Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.
Detailed description
This is a Canadian Post Marketing Observational Study utilizing a prospective cohort design. Patients with Prostate Cancer who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.
Interventions
None listed
Sponsors
JSS Medical Research Inc.
CMX Research
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel * Diagnosed with Prostate Cancer * Prescribed Lupron as part of his treatment by his treating physician
Exclusion criteria
* Currently participating in another prospective study including controlled clinical trials and observational studies. * Patient cannot or will not sign informed consent * Survival expectancy less than 2-3 years as per the treating physician's judgment * Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Prostate Cancer * History of alcohol or drug abuse * No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 | 36 months | PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. |
| Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests | 36 months | A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 | Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, \> 0.7 to ≤ 1.7 nmol/L, and \> 1.7 nmol/L are provided at each time point. |
| Total Serum Testosterone Levels at Each Visit | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 | Total serum testosterone was assessed at each study visit. |
| Total Serum Testosterone: Time to Increase Over Castrate Levels | 36 months | Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (\>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. |
| Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 | Serum PSA was assessed at each study visit. The percentage of participants with serum PSA \< 1 ng/mL, 1 to \< 5 ng/mL, 5 to \< 10 ng/mL, and ≥10 ng/mL are provided at each time point. |
| Prostatic Specific Antigen (PSA) Levels at Each Visit | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 | Serum PSA was assessed at each study visit. |
| Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL. |
| Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL. |
| International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36 | IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Castration Resistant Prostate Cancer (CRPC): Number of Participants | 36 months | CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Treatment Compliance | Months 3, 6, 12, 18, 24, 30, and 36 | Treatment compliance by participants was assessed as the number of missed injections since the last visit. |
| Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Months 3, 6, 12, 18, 24, 30, and 36 | Participants were asked Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?; if Yes, was the change Initiation of new mediation/Change in Dose/Frequency or Discontinuation of medication. The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented. |
| Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. |
| Castration Resistant Prostate Cancer (CRPC): Time to Event | 36 months | CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Prostate Cancer Patients with prostate cancer who were receiving treatment with Lupron. | 552 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Alternative Therapy Required | 37 |
| Overall Study | Death | 47 |
| Overall Study | Disease Progression | 28 |
| Overall Study | Lost to Follow-up | 51 |
| Overall Study | Missing | 3 |
| Overall Study | Noncompliance | 8 |
| Overall Study | Other | 51 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal of Consent | 44 |
Baseline characteristics
| Characteristic | Patients With Prostate Cancer |
|---|---|
| Age, Continuous | 76.3 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 552 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 77 / 552 |
| serious Total, serious adverse events | 132 / 552 |
Outcome results
Primary
Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests
A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Prostate Cancer | Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests | 21.89 months | Standard Error 0.69 |
Primary
Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0
PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Prostate Cancer | Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 | 20.76 months | Standard Error 0.59 |
Secondary
Castration Resistant Prostate Cancer (CRPC): Number of Participants
CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests.
Time frame: 36 months
Population: All participants who achieved PSA levels ≤ 2 ng/mL
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Prostate Cancer | Castration Resistant Prostate Cancer (CRPC): Number of Participants | 84 participants |
Secondary
Castration Resistant Prostate Cancer (CRPC): Time to Event
CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.
Time frame: 36 months
Population: All participants who achieved PSA levels ≤2 ng/mL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Prostate Cancer | Castration Resistant Prostate Cancer (CRPC): Time to Event | 26.01 months | Standard Error 0.42 |
Secondary
Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit
The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 3 | -0.9 units on a scale | Standard Error 0.6 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 6 | -2.2 units on a scale | Standard Error 0.6 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 12 | -1.7 units on a scale | Standard Error 0.6 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 18 | -1.0 units on a scale | Standard Error 0.7 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 24 | -1.4 units on a scale | Standard Error 0.7 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 30 | -1.3 units on a scale | Standard Error 0.7 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | Month 36 | -1.9 units on a scale | Standard Error 0.8 |
Secondary
Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit
The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 3 | -1.1 units on a scale | Standard Error 0.8 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 6 | -2.8 units on a scale | Standard Error 0.8 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 12 | -2.4 units on a scale | Standard Error 0.9 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 18 | -1.8 units on a scale | Standard Error 0.9 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 24 | -2.1 units on a scale | Standard Error 0.9 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 30 | -2.3 units on a scale | Standard Error 1 |
| Patients With Prostate Cancer | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | Month 36 | -3.0 units on a scale | Standard Error 1 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who were admitted to the hospital and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 0 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 3 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 6 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 12 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 18 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 24 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 30 | 1.0 admissions to the hospital | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | Month 36 | 1.0 admissions to the hospital | Standard Deviation 0 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 0 | 4 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 3 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 6 | 4 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 12 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 18 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 24 | 3 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 30 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | Month 36 | 1 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 0 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 3 | 8 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 6 | 12 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 12 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 18 | 5 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 24 | 6 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 30 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | Month 36 | 2 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 0 | 20 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 3 | 23 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 6 | 20 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 12 | 21 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 18 | 8 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 24 | 11 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 30 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | Month 36 | 3 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 0 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 3 | 7 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 6 | 3 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 12 | 8 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 18 | 5 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 24 | 6 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 30 | 4 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | Month 36 | 2 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 0 | 38 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 3 | 44 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 6 | 38 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 12 | 34 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 18 | 20 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 24 | 23 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 30 | 14 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | Month 36 | 8 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 0 | 3 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 3 | 2 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 6 | 1 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 12 | 4 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 18 | 3 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 24 | 0 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 30 | 0 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | Month 36 | 1 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 0 | 29 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 3 | 14 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 6 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 12 | 14 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 18 | 9 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 24 | 5 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 30 | 4 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | Month 36 | 8 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available data at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 0 | 452 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 3 | 408 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 6 | 384 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 12 | 328 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 18 | 279 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 24 | 258 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 30 | 220 Participants |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | Month 36 | 196 Participants |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had used an ambulance service and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | Month 0 | 1.0 ambulance service uses |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | Month 6 | 1.0 ambulance service uses |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | Month 18 | 1.0 ambulance service uses |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | Month 30 | 1.0 ambulance service uses |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had visited for any other medical service and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 0 | 7.4 visits for any other medical service | Standard Deviation 12.66 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 3 | 2.0 visits for any other medical service | Standard Deviation 2 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 6 | 1.0 visits for any other medical service | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 12 | 1.0 visits for any other medical service | Standard Deviation 0 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | Month 36 | 1.0 visits for any other medical service | — |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had visited complementary/alternate therapy and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | Month 0 | 1.0 complementary/alternate therapy visits | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | Month 3 | 1.0 complementary/alternate therapy visits | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | Month 12 | 3.5 complementary/alternate therapy visits | Standard Deviation 2.12 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had visited a hospital emergency room and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 0 | 1.2 hospital emergency room visits | Standard Deviation 0.45 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 3 | 1.0 hospital emergency room visits | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 6 | 1.0 hospital emergency room visits | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 12 | 1.4 hospital emergency room visits | Standard Deviation 0.55 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 18 | 1.0 hospital emergency room visits | — |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | Month 30 | 1.0 hospital emergency room visits | Standard Deviation 0 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had visited a healthcare professional and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 0 | 7.8 healthcare professional visits | Standard Deviation 14.05 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 3 | 3.5 healthcare professional visits | Standard Deviation 4.11 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 6 | 18.5 healthcare professional visits | Standard Deviation 19.06 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 12 | 3.1 healthcare professional visits | Standard Deviation 2.12 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 18 | 2.3 healthcare professional visits | Standard Deviation 0.96 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 24 | 1.7 healthcare professional visits | Standard Deviation 1.15 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | Month 30 | 1.6 healthcare professional visits | Standard Deviation 0.89 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants who had visited a physician and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 0 | 1.2 physician visits | Standard Deviation 0.56 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 3 | 1.5 physician visits | Standard Deviation 0.84 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 6 | 7.1 physician visits | Standard Deviation 13.93 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 12 | 1.6 physician visits | Standard Deviation 1.17 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 18 | 2.7 physician visits | Standard Deviation 1.86 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 24 | 2.4 physician visits | Standard Deviation 1.14 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 30 | 2.0 physician visits | Standard Deviation 1 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | Month 36 | 2.0 physician visits | Standard Deviation 0 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for health care or extra help at home and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 0 | 4.9 dollars (CAD) | Standard Deviation 58.06 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 3 | 4.9 dollars (CAD) | Standard Deviation 60.31 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 6 | 14.7 dollars (CAD) | Standard Deviation 189.44 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 12 | 28.9 dollars (CAD) | Standard Deviation 390.75 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 18 | 0.4 dollars (CAD) | Standard Deviation 6.21 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 24 | 1.4 dollars (CAD) | Standard Deviation 14.26 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 30 | 3.0 dollars (CAD) | Standard Deviation 24.16 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | Month 36 | 11.8 dollars (CAD) | Standard Deviation 92.4 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for medical devices and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 0 | 4.0 dollars (CAD) | Standard Deviation 40.46 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 3 | 7.5 dollars (CAD) | Standard Deviation 58 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 6 | 21.0 dollars (CAD) | Standard Deviation 292.53 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 12 | 7.3 dollars (CAD) | Standard Deviation 96.5 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 18 | 2.1 dollars (CAD) | Standard Deviation 16.79 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 24 | 2.4 dollars (CAD) | Standard Deviation 22.88 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 30 | 1.5 dollars (CAD) | Standard Deviation 12.96 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | Month 36 | 2.0 dollars (CAD) | Standard Deviation 24.66 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for medical procedures and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 0 | 14.0 dollars (CAD) | Standard Deviation 91.76 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 3 | 2.6 dollars (CAD) | Standard Deviation 22.01 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 6 | 4.1 dollars (CAD) | Standard Deviation 33.59 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 12 | 3.0 dollars (CAD) | Standard Deviation 20.96 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 18 | 2.7 dollars (CAD) | Standard Deviation 18.39 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 24 | 6.8 dollars (CAD) | Standard Deviation 54.35 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 30 | 5.2 dollars (CAD) | Standard Deviation 35.89 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | Month 36 | 2.9 dollars (CAD) | Standard Deviation 20.11 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for over-the-counter medications and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 0 | 21.5 dollars (CAD) | Standard Deviation 73.5 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 3 | 19.3 dollars (CAD) | Standard Deviation 101.66 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 6 | 25.5 dollars (CAD) | Standard Deviation 130.41 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 12 | 26.6 dollars (CAD) | Standard Deviation 101.28 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 18 | 20.9 dollars (CAD) | Standard Deviation 80.53 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 24 | 13.9 dollars (CAD) | Standard Deviation 60.01 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 30 | 13.4 dollars (CAD) | Standard Deviation 54.69 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | Month 36 | 13.1 dollars (CAD) | Standard Deviation 55.12 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 0 | 14.0 dollars (CAD) | Standard Deviation 91.76 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 3 | 2.6 dollars (CAD) | Standard Deviation 22.01 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 6 | 4.1 dollars (CAD) | Standard Deviation 33.59 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 12 | 3.0 dollars (CAD) | Standard Deviation 20.96 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 18 | 2.7 dollars (CAD) | Standard Deviation 18.39 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 24 | 6.8 dollars (CAD) | Standard Deviation 54.35 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 30 | 5.2 dollars (CAD) | Standard Deviation 35.89 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | Month 36 | 2.9 dollars (CAD) | Standard Deviation 20.11 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for payments to health care professionals and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 0 | 0.9 dollars (CAD) | Standard Deviation 11.66 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 3 | 2.5 dollars (CAD) | Standard Deviation 30.24 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 6 | 2.5 dollars (CAD) | Standard Deviation 31.18 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 12 | 0.8 dollars (CAD) | Standard Deviation 12.8 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 18 | 2.4 dollars (CAD) | Standard Deviation 34.67 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 24 | 2.6 dollars (CAD) | Standard Deviation 36.27 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 30 | 1.6 dollars (CAD) | Standard Deviation 19.95 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | Month 36 | 7.9 dollars (CAD) | Standard Deviation 62.5 |
Secondary
Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer
The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time frame: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with out of pocket expenses for transportation costs and with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 0 | 20.0 dollars (CAD) | Standard Deviation 124.86 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 3 | 19.5 dollars (CAD) | Standard Deviation 77.92 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 6 | 23.0 dollars (CAD) | Standard Deviation 96.03 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 12 | 9.2 dollars (CAD) | Standard Deviation 27.87 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 18 | 6.3 dollars (CAD) | Standard Deviation 19.88 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 24 | 10.6 dollars (CAD) | Standard Deviation 87.22 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 30 | 8.2 dollars (CAD) | Standard Deviation 26.54 |
| Patients With Prostate Cancer | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | Month 36 | 2.7 dollars (CAD) | Standard Deviation 9.3 |
Secondary
International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit
IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.
Time frame: Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 6 | -2.7 units on a scale | Standard Error 0.3 |
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 12 | -3.2 units on a scale | Standard Error 0.3 |
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 18 | -3.3 units on a scale | Standard Error 0.3 |
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 24 | -3.7 units on a scale | Standard Error 0.3 |
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 30 | -3.5 units on a scale | Standard Error 0.3 |
| Patients With Prostate Cancer | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | Month 36 | -3.3 units on a scale | Standard Error 0.3 |
Secondary
Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.
Participants were asked Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?; if Yes, was the change Initiation of new mediation/Change in Dose/Frequency or Discontinuation of medication. The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented.
Time frame: Months 3, 6, 12, 18, 24, 30, and 36
Population: The number of participants with changes in current prostate cancer treatment since the last visit at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 3 Initiation or Change in Dose/Frequency | 9.4 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 3 Discontinuation of Medication | 90.6 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 6 Initiation or Change in Dose/Frequency | 42.6 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 6 Discontinuation of Medication | 57.4 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 12 Initiation or Change in Dose/Frequency | 54.1 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 12 Discontinuation of Medication | 45.9 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 18 Initiation or Change in Dose/Frequency | 45.0 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 18 Discontinuation of Medication | 45.0 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 24 Initiation or Change in Dose/Frequency | 60.0 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 24 Discontinuation of Medication | 40.0 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 30 Initiation or Change in Dose/Frequency | 71.4 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 30 Discontinuation of Medication | 28.6 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 36 Initiation or Change in Dose/Frequency | 57.1 percentage of participants |
| Patients With Prostate Cancer | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Month 36 Discontinuation of Medication | 42.9 percentage of participants |
Secondary
Prostatic Specific Antigen (PSA) Levels at Each Visit
Serum PSA was assessed at each study visit.
Time frame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 0 | 65.0 ng/ml | Standard Deviation 377.6 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 3 | 6.5 ng/ml | Standard Deviation 41.33 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 6 | 12.0 ng/ml | Standard Deviation 80.64 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 12 | 19.1 ng/ml | Standard Deviation 128.51 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 18 | 13.3 ng/ml | Standard Deviation 113.98 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 24 | 11.2 ng/ml | Standard Deviation 56.69 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 30 | 13.5 ng/ml | Standard Deviation 65.79 |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA) Levels at Each Visit | Month 36 | 8.2 ng/ml | Standard Deviation 37.12 |
Secondary
Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit
Serum PSA was assessed at each study visit. The percentage of participants with serum PSA \< 1 ng/mL, 1 to \< 5 ng/mL, 5 to \< 10 ng/mL, and ≥10 ng/mL are provided at each time point.
Time frame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available date at given time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 24: ≥10 ng/mL | 16.1 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 0: <1 ng/mL | 15.2 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 3: <1 ng/mL | 55.9 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 6: <1 ng/mL | 61.8 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 12: <1 ng/mL | 63.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 18: <1 ng/mL | 64.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 24: <1 ng/mL | 60.7 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 30: <1 ng/mL | 56.9 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 36: <1 ng/mL | 57.5 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 0: 1 to <5 ng/mL | 17.4 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 3: 1 to <5 ng/mL | 31.4 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 6: 1 to <5 ng/mL | 21.5 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 12: 1 to <5 ng/mL | 16.8 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 18: 1 to <5 ng/mL | 17.9 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 24: 1 to <5 ng/mL | 16.4 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 30: 1 to <5 ng/mL | 19.8 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 36: 1 to <5 ng/mL | 18.9 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 0: 5 to <10 ng/mL | 17.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 3: 5 to <10 ng/mL | 4.1 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 6: 5 to <10 ng/mL | 7.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 12: 5 to <10 ng/mL | 7.5 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 18: 5 to <10 ng/mL | 8.9 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 24: 5 to <10 ng/mL | 6.8 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 30: 5 to <10 ng/mL | 7.5 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 36: 5 to <10 ng/mL | 9.0 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 0: ≥10 ng/mL | 49.7 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 3: ≥10 ng/mL | 8.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 6: ≥10 ng/mL | 9.0 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 12: ≥10 ng/mL | 12.1 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 18: ≥10 ng/mL | 8.6 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 30: ≥10 ng/mL | 15.8 percentage of participants |
| Patients With Prostate Cancer | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Month 36: ≥10 ng/mL | 14.6 percentage of participants |
Secondary
Total Serum Testosterone Levels at Each Visit
Total serum testosterone was assessed at each study visit.
Time frame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 0 | 10.9 nmol/L | Standard Deviation 8.9 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 3 | 0.6 nmol/L | Standard Deviation 0.98 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 6 | 1.0 nmol/L | Standard Deviation 2.32 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 12 | 1.5 nmol/L | Standard Deviation 3.29 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 18 | 1.9 nmol/L | Standard Deviation 4.05 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 24 | 2.1 nmol/L | Standard Deviation 4.31 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 30 | 2.3 nmol/L | Standard Deviation 4.81 |
| Patients With Prostate Cancer | Total Serum Testosterone Levels at Each Visit | Month 36 | 2.9 nmol/L | Standard Deviation 4.69 |
Secondary
Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit
Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, \> 0.7 to ≤ 1.7 nmol/L, and \> 1.7 nmol/L are provided at each time point.
Time frame: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available data at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 0: ≤ 0.7 nmol/L | 16.3 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 3: ≤ 0.7 nmol/L | 65.3 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 6: ≤ 0.7 nmol/L | 62.9 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 12: ≤ 0.7 nmol/L | 68.8 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 18: ≤ 0.7 nmol/L | 69.0 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 24: ≤ 0.7 nmol/L | 68.8 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 30: ≤ 0.7 nmol/L | 69.2 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 36: ≤ 0.7 nmol/L | 55.7 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 0: > 0.7 to ≤ 1.7 nmol/L | 6.3 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 3: > 0.7 to ≤ 1.7 nmol/L | 32.7 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 6: > 0.7 to ≤ 1.7 nmol/L | 31.4 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 12: > 0.7 to ≤ 1.7 nmol/L | 18.8 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 18: > 0.7 to ≤ 1.7 nmol/L | 15.5 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 24: > 0.7 to ≤ 1.7 nmol/L | 12.5 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 30: > 0.7 to ≤ 1.7 nmol/L | 12.8 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 36: > 0.7 to ≤ 1.7 nmol/L | 15.6 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 0: > 1.7 nmol/L | 77.4 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 3: > 1.7 nmol/L | 2.0 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 6: > 1.7 nmol/L | 5.7 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 12: > 1.7 nmol/L | 12.5 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 18: > 1.7 nmol/L | 15.5 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 24: > 1.7 nmol/L | 18.8 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 30: > 1.7 nmol/L | 18.0 percentage of participants |
| Patients With Prostate Cancer | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Month 36: > 1.7 nmol/L | 28.7 percentage of participants |
Secondary
Total Serum Testosterone: Time to Increase Over Castrate Levels
Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (\>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time frame: 36 months
Population: All participants who achieved castrate testosterone levels (≤1.7 nmol/L)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Prostate Cancer | Total Serum Testosterone: Time to Increase Over Castrate Levels | 31.20 months | Standard Error 0.67 |
Secondary
Treatment Compliance
Treatment compliance by participants was assessed as the number of missed injections since the last visit.
Time frame: Months 3, 6, 12, 18, 24, 30, and 36
Population: All participants with available data at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Prostate Cancer | Treatment Compliance | Month 6 | 0.0 missed injections | Standard Deviation 0.17 |
| Patients With Prostate Cancer | Treatment Compliance | Month 3 | 0.0 missed injections | Standard Deviation 0.12 |
| Patients With Prostate Cancer | Treatment Compliance | Month 12 | 0.1 missed injections | Standard Deviation 0.35 |
| Patients With Prostate Cancer | Treatment Compliance | Month 18 | 0.2 missed injections | Standard Deviation 0.53 |
| Patients With Prostate Cancer | Treatment Compliance | Month 24 | 0.2 missed injections | Standard Deviation 0.66 |
| Patients With Prostate Cancer | Treatment Compliance | Month 30 | 0.2 missed injections | Standard Deviation 0.57 |
| Patients With Prostate Cancer | Treatment Compliance | Month 36 | 0.2 missed injections | Standard Deviation 0.83 |