Cancer of Prostate, Cancer of the Prostate, Prostate Cancer, Prostatic Cancer
Conditions
Brief summary
Through this study, the investigators seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies-every three vs. six vs. 12 months. Using the National Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the investigators aim to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies and compare quality-of-life outcomes. The overall goal of the study is to provide high-quality data that will allow development of a personalized, risk-based tailored approach to post-treatment surveillance for prostate cancer.
Detailed description
We seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies--every three vs. six vs. 12 months. We hypothesize that patients with a low risk of recurrence may experience more harm than benefit, while patients with a high risk of recurrence may have improved survival from frequent surveillance. Specific aims: The specific aims are 1) compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies; and 2) compare quality-of-life outcomes. Methods: Aim 1 will use the National Cancer Database, which includes 70 percent of cancer patients across the United States, and will provide results representative of outcomes of prostate cancer survivors. We will compare the effectiveness of the three most common surveillance frequencies (PSA testing every 3 months vs. 6 months vs. 12 months) stratified by risk of recurrence (low-risk, intermediate-risk, high-risk; as defined by the National Comprehensive Cancer Network (NCCN)) and initial treatment (surgery or radiation). The objective of this aim is to quantify the potential benefits (survival) and harms (procedures/tests, treatments, morbidity consequences) of different PSA surveillance frequencies in the 6 patient groups. The objective of Aim 2 is to quantify the impact of different surveillance frequencies from the patient's perspective. This aim will use quality-of-life data from the North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS), PI Ronald Chen, a prospective population-based cohort of \>1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013. Comparison groups are the same as Aim 1. PSA frequency will be similarly defined using medical record abstraction. Patient and stakeholder engagement: Through a five-year process, patients have worked with the PI in all phases of this research, including 1) identifying the highest priority research topic, 2) defining the study population/comparators, and 3) identifying outcomes of highest relevance to patients. Patients and other stakeholders will continue to 4) monitor study conduct and progress and 5) design dissemination activities.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
Alliance Foundation Trials, LLC.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
for the National Cancer Data Base cohort: * Patient data part of the NCDB * Diagnosed with prostate cancer in 2004-2005. * Treated for prostate cancer with surgery (prostatectomy) or radiation therapy Inclusion/
Exclusion criteria
for the NC ProCESS cohort: Inclusion Criteria: * Newly-diagnosed, histologically-proven, localized prostate adenocarcinoma. * Completion of baseline interview prior to initiating therapy. * Patient ability to complete study interview: no cognitive impairment, language or hearing problems. * Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP). * Age 35-80. * English speaking. * Has telephone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From completion of primary treatment with surgery or radiation to the earliest occurrence of death, loss to follow-up, or the end of the study period. | Time to death or date of last follow-up after primary treatment with surgery or radiation. |
| Prostate Cancer Anxiety | 12 to 60 months after participant enrollment | Prostate cancer anxiety was measured annually (starting 12 months after participant enrollment) using the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The instrument contains 18 questions across 3 subscales assessing anxiety related to prostate cancer (11 items), PSA testing (3 items), and fear of recurrence (4 items). Each item was scored on a Likert-type scale (1 to 4), with a higher score indicating greater anxiety. The subscale means represent the average scores across the items in that sub-scale. The mean Total MAX-PC scores represent the average scores across the 3 subscales (anxiety related to prostate cancer; anxiety related to PSA testing; and anxiety related to prostate cancer recurrence). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Prostate Cancer Recurrence | Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period | Time to recurrence represents the period between completion of the first course of treatment (i.e., radiation or surgery) and the date of prostate cancer recurrence (if prostate cancer recurrence occurred). |
| Treatment for Prostate Cancer Recurrence | Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period | Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation. |
| Prostate Cancer-Specific Health-Related Quality of Life | 12 to 60 months after participant enrollment | Prostate cancer-specific health-related quality of life was assessed using the validated and well-published Prostate Cancer Symptom Indices (PCSI). PCSI assesses treatment-related morbidity and includes scales that measure sexual, bowel, and urinary symptoms. Patient responses are converted to a score from 0 (no symptoms) to 100 (maximum symptoms). A higher score indicates greater morbidity and poorer organ system function. PCSI was assessed at baseline, 3 months, 12 months and annually thereafter. |
| Global Health-Related Quality of Life | 12 to 60 months after participant enrollment | Global health-related quality of life was assessed using the validated Short-Form 12 (SF-12). The SF-12 survey consists of Likert response formats and assesses overall health, mental health, vitality, social functioning, and whether one's daily physical activities are limited by their health or pain. The SF-12 also includes four binary response (yes or no) questions that assess limitations in function due to physical and emotional health. The SF-12 provides a Mental Component Score and a Physical Component Score, each calculated using norm-based scoring, with a mean score of 50 and standard deviation of 10. A lower score indicates lower health-related quality of life. SF-12 was assessed at baseline, 3 months, 12 months and annually thereafter. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| National Cancer Data Base Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort. | 10,479 |
| NC ProCESS The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a prospective population-based cohort of \>1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013. | 835 |
| Total | 11,314 |
Baseline characteristics
| Characteristic | National Cancer Data Base | Total | NC ProCESS |
|---|---|---|---|
| Age, Customized Age group <55 | 1329 Participants | 1444 Participants | 115 Participants |
| Age, Customized Age group 55-64 | 4059 Participants | 4393 Participants | 334 Participants |
| Age, Customized Age group 65-75 | 5091 Participants | 5436 Participants | 345 Participants |
| Age, Customized Age group >75 | 0 Participants | 41 Participants | 41 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1375 Participants | 1623 Participants | 248 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 7561 Participants | 8111 Participants | 550 Participants |
| Race/Ethnicity, Customized Other | 1543 Participants | 1580 Participants | 37 Participants |
| Region of Enrollment United States | 10479 participants | 11314 participants | 835 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10479 Participants | 11314 Participants | 835 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Survival
Time to death or date of last follow-up after primary treatment with surgery or radiation.
Time frame: From completion of primary treatment with surgery or radiation to the earliest occurrence of death, loss to follow-up, or the end of the study period.
Population: Analysis population comprised patients in the National Cancer Data Base, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Survival data on patients in NC ProCESS were not collected for this assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Low Risk/Radiation | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.2 years |
| Low Risk/Radiation | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 8.7 years |
| Low Risk/Radiation | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.2 years |
| Low Risk/Surgery | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.4 years |
| Low Risk/Surgery | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 8.8 years |
| Low Risk/Surgery | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.6 years |
| Intermediate Risk/Radiation | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.3 years |
| Intermediate Risk/Radiation | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 8.6 years |
| Intermediate Risk/Radiation | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.3 years |
| Intermediate Risk/Surgery | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.7 years |
| Intermediate Risk/Surgery | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 9.0 years |
| Intermediate Risk/Surgery | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.9 years |
| High Risk/Radiation | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.6 years |
| High Risk/Radiation | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 8.8 years |
| High Risk/Radiation | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.36 years |
| High Risk/Surgery | Overall Survival | Participants with <= 1 PSA test in the first year after treatment | 8.9 years |
| High Risk/Surgery | Overall Survival | Participants with >=3 PSA tests in the first year after treatment | 8.9 years |
| High Risk/Surgery | Overall Survival | Participants with 2 PSA tests in the first year after treatment | 8.6 years |
Primary
Prostate Cancer Anxiety
Prostate cancer anxiety was measured annually (starting 12 months after participant enrollment) using the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The instrument contains 18 questions across 3 subscales assessing anxiety related to prostate cancer (11 items), PSA testing (3 items), and fear of recurrence (4 items). Each item was scored on a Likert-type scale (1 to 4), with a higher score indicating greater anxiety. The subscale means represent the average scores across the items in that sub-scale. The mean Total MAX-PC scores represent the average scores across the 3 subscales (anxiety related to prostate cancer; anxiety related to PSA testing; and anxiety related to prostate cancer recurrence).
Time frame: 12 to 60 months after participant enrollment
Population: The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness \& Survivorship Study who received primary treatment with either radiation therapy or surgery.~Data were not collected from the National Cancer Data Base for this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 12 months | 1.56 score on a scale | Standard Deviation 0.7 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 48 months | 1.64 score on a scale | Standard Deviation 0.58 |
| Low Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 24 months | 1.10 score on a scale | Standard Deviation 0.32 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 12 months | 1.70 score on a scale | Standard Deviation 0.68 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 36 months | 1.60 score on a scale | Standard Deviation 0.63 |
| Low Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 36 months | 1.16 score on a scale | Standard Deviation 0.39 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 48 months | 1.40 score on a scale | Standard Deviation 0.44 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 24 months | 1.68 score on a scale | Standard Deviation 0.63 |
| Low Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 48 months | 1.10 score on a scale | Standard Deviation 0.26 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 48 months | 1.40 score on a scale | Standard Deviation 0.44 |
| Low Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 60 months | 1.11 score on a scale | Standard Deviation 0.3 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 12 months | 1.53 score on a scale | Standard Deviation 0.59 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 36 months | 1.43 score on a scale | Standard Deviation 0.51 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 36 months | 1.40 score on a scale | Standard Deviation 0.57 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 60 months | 1.40 score on a scale | Standard Deviation 0.53 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 24 months | 1.38 score on a scale | Standard Deviation 0.47 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 60 months | 1.37 score on a scale | Standard Deviation 0.64 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 24 months | 1.35 score on a scale | Standard Deviation 0.57 |
| Low Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 60 months | 1.70 score on a scale | Standard Deviation 0.7 |
| Low Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 12 months | 1.19 score on a scale | Standard Deviation 0.55 |
| Low Risk/Surgery | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 24 months | 1.23 score on a scale | Standard Deviation 0.53 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 36 months | 1.57 score on a scale | Standard Deviation 0.56 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 60 months | 1.49 score on a scale | Standard Deviation 0.51 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 12 months | 1.60 score on a scale | Standard Deviation 0.74 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 24 months | 1.57 score on a scale | Standard Deviation 0.7 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 48 months | 1.51 score on a scale | Standard Deviation 0.53 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 36 months | 1.51 score on a scale | Standard Deviation 0.64 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 60 months | 1.47 score on a scale | Standard Deviation 0.63 |
| Low Risk/Surgery | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 12 months | 1.22 score on a scale | Standard Deviation 0.49 |
| Low Risk/Surgery | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 36 months | 1.25 score on a scale | Standard Deviation 0.55 |
| Low Risk/Surgery | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 48 months | 1.23 score on a scale | Standard Deviation 0.51 |
| Low Risk/Surgery | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 60 months | 1.19 score on a scale | Standard Deviation 0.48 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 12 months | 1.82 score on a scale | Standard Deviation 0.69 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 24 months | 1.78 score on a scale | Standard Deviation 0.61 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 36 months | 1.85 score on a scale | Standard Deviation 0.73 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 48 months | 1.73 score on a scale | Standard Deviation 0.62 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 60 months | 1.77 score on a scale | Standard Deviation 0.59 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 12 months | 1.59 score on a scale | Standard Deviation 0.6 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 24 months | 1.57 score on a scale | Standard Deviation 0.55 |
| Low Risk/Surgery | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 48 months | 1.51 score on a scale | Standard Deviation 0.53 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 36 months | 1.44 score on a scale | Standard Deviation 0.49 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 36 months | 1.68 score on a scale | Standard Deviation 0.63 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 12 months | 1.15 score on a scale | Standard Deviation 0.39 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 24 months | 1.45 score on a scale | Standard Deviation 0.6 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 48 months | 1.75 score on a scale | Standard Deviation 0.71 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 60 months | 1.39 score on a scale | Standard Deviation 0.61 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 60 months | 1.42 score on a scale | Standard Deviation 0.49 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 60 months | 1.69 score on a scale | Standard Deviation 0.65 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 48 months | 1.47 score on a scale | Standard Deviation 0.55 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 12 months | 1.50 score on a scale | Standard Deviation 0.49 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 36 months | 1.46 score on a scale | Standard Deviation 0.63 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 48 months | 1.16 score on a scale | Standard Deviation 0.48 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 12 months | 1.52 score on a scale | Standard Deviation 0.62 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 60 months | 1.11 score on a scale | Standard Deviation 0.34 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Total MAX-PC (average of subscale means) at 24 months | 1.45 score on a scale | Standard Deviation 0.5 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 12 months | 1.71 score on a scale | Standard Deviation 0.6 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 36 months | 1.16 score on a scale | Standard Deviation 0.41 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Anxiety (Subscale 1) at 48 months | 1.47 score on a scale | Standard Deviation 0.55 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | Prostate Cancer Recurrence Anxiety (Subscale 3) at 24 months | 1.70 score on a scale | Standard Deviation 0.66 |
| Intermediate Risk/Radiation | Prostate Cancer Anxiety | PSA Test Anxiety (Subscale 2) at 24 months | 1.13 score on a scale | Standard Deviation 0.39 |
Secondary
Global Health-Related Quality of Life
Global health-related quality of life was assessed using the validated Short-Form 12 (SF-12). The SF-12 survey consists of Likert response formats and assesses overall health, mental health, vitality, social functioning, and whether one's daily physical activities are limited by their health or pain. The SF-12 also includes four binary response (yes or no) questions that assess limitations in function due to physical and emotional health. The SF-12 provides a Mental Component Score and a Physical Component Score, each calculated using norm-based scoring, with a mean score of 50 and standard deviation of 10. A lower score indicates lower health-related quality of life. SF-12 was assessed at baseline, 3 months, 12 months and annually thereafter.
Time frame: 12 to 60 months after participant enrollment
Population: The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness \& Survivorship Study who received primary treatment with either radiation therapy or surgery.~Data were not collected from the National Cancer Data Base for this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 12-months | 48.0 score on a scale | Standard Deviation 9.7 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 24-months | 45.9 score on a scale | Standard Deviation 10.5 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 36-months | 48.2 score on a scale | Standard Deviation 10.4 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 48-months | 47.9 score on a scale | Standard Deviation 9.1 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 60-months | 45.8 score on a scale | Standard Deviation 10.5 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 12-months | 53.9 score on a scale | Standard Deviation 8 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 24-months | 53.2 score on a scale | Standard Deviation 8.3 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 36-months | 53.6 score on a scale | Standard Deviation 9.5 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 48-months | 52.4 score on a scale | Standard Deviation 10.3 |
| Low Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 60-months | 53.6 score on a scale | Standard Deviation 9.5 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Mental health score at 48-months | 54.2 score on a scale | Standard Deviation 8.5 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Physical health score at 12-months | 49.2 score on a scale | Standard Deviation 9.1 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Mental health score at 12-months | 54.1 score on a scale | Standard Deviation 7.4 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Physical health score at 60-months | 45.5 score on a scale | Standard Deviation 10.9 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Physical health score at 24-months | 48.2 score on a scale | Standard Deviation 10.2 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Mental health score at 60-months | 54.7 score on a scale | Standard Deviation 7.8 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Mental health score at 36-months | 53.8 score on a scale | Standard Deviation 9.1 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Physical health score at 36-months | 48.0 score on a scale | Standard Deviation 10.7 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Mental health score at 24-months | 53.2 score on a scale | Standard Deviation 9.4 |
| Low Risk/Surgery | Global Health-Related Quality of Life | Physical health score at 48-months | 47.6 score on a scale | Standard Deviation 10 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 36-months | 54.7 score on a scale | Standard Deviation 8.5 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 48-months | 48.0 score on a scale | Standard Deviation 10.5 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 60-months | 47.5 score on a scale | Standard Deviation 9.9 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 12-months | 54.7 score on a scale | Standard Deviation 8.1 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 48-months | 55.2 score on a scale | Standard Deviation 8.6 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 24-months | 55.1 score on a scale | Standard Deviation 8.4 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 12-months | 49.9 score on a scale | Standard Deviation 9.7 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Mental health score at 60-months | 55.3 score on a scale | Standard Deviation 8.1 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 24-months | 48.5 score on a scale | Standard Deviation 9.8 |
| Intermediate Risk/Radiation | Global Health-Related Quality of Life | Physical health score at 36-months | 48.7 score on a scale | Standard Deviation 9.4 |
Secondary
Prostate Cancer-Specific Health-Related Quality of Life
Prostate cancer-specific health-related quality of life was assessed using the validated and well-published Prostate Cancer Symptom Indices (PCSI). PCSI assesses treatment-related morbidity and includes scales that measure sexual, bowel, and urinary symptoms. Patient responses are converted to a score from 0 (no symptoms) to 100 (maximum symptoms). A higher score indicates greater morbidity and poorer organ system function. PCSI was assessed at baseline, 3 months, 12 months and annually thereafter.
Time frame: 12 to 60 months after participant enrollment
Population: The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness \& Survivorship Study who received primary treatment with either radiation therapy or surgery.~Data were not collected from the National Cancer Data Base for this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 36-months | 69.4 score on a scale | Standard Deviation 32.7 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 36-months | 21.4 score on a scale | Standard Deviation 11.4 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 36-months | 24.3 score on a scale | Standard Deviation 25.6 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 48-months | 6.8 score on a scale | Standard Deviation 7 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 24-months | 20.2 score on a scale | Standard Deviation 11.3 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 48-months | 21.1 score on a scale | Standard Deviation 23.9 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 60-months | 8.5 score on a scale | Standard Deviation 10.9 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 12-months | 24.9 score on a scale | Standard Deviation 14.2 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 60-months | 24.0 score on a scale | Standard Deviation 23.1 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 24-months | 7.6 score on a scale | Standard Deviation 9.3 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 48-months | 74.9 score on a scale | Standard Deviation 29.6 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 24-months | 68.4 score on a scale | Standard Deviation 31.5 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 12-months | 8.7 score on a scale | Standard Deviation 12.4 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 60-months | 75.4 score on a scale | Standard Deviation 26.8 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 12-months | 70.7 score on a scale | Standard Deviation 32.9 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 60-months | 21.3 score on a scale | Standard Deviation 11.6 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 12-months | 25.4 score on a scale | Standard Deviation 26.6 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 36-months | 7.7 score on a scale | Standard Deviation 9.9 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 48-months | 20.0 score on a scale | Standard Deviation 11.1 |
| Low Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 24-months | 22.9 score on a scale | Standard Deviation 26.6 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 36-months | 23.5 score on a scale | Standard Deviation 24.9 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 12-months | 64.5 score on a scale | Standard Deviation 34.5 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 24-months | 63.8 score on a scale | Standard Deviation 35.2 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 36-months | 64.8 score on a scale | Standard Deviation 32.9 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 48-months | 64.2 score on a scale | Standard Deviation 34.8 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 60-months | 69.7 score on a scale | Standard Deviation 32.8 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 12-months | 22.3 score on a scale | Standard Deviation 26.6 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 24-months | 22.5 score on a scale | Standard Deviation 24.1 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 48-months | 25.0 score on a scale | Standard Deviation 25.2 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 60-months | 26.6 score on a scale | Standard Deviation 27.4 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 12-months | 21.8 score on a scale | Standard Deviation 14 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 24-months | 20.4 score on a scale | Standard Deviation 13.5 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 36-months | 20.6 score on a scale | Standard Deviation 12.8 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 48-months | 20.4 score on a scale | Standard Deviation 13.3 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 60-months | 21.4 score on a scale | Standard Deviation 14.2 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 12-months | 7.6 score on a scale | Standard Deviation 9.6 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 24-months | 8.0 score on a scale | Standard Deviation 12.4 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 36-months | 6.8 score on a scale | Standard Deviation 9 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 48-months | 6.2 score on a scale | Standard Deviation 8.6 |
| Low Risk/Surgery | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 60-months | 6.8 score on a scale | Standard Deviation 9.3 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 12-months | 29.4 score on a scale | Standard Deviation 27.1 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 12-months | 68.9 score on a scale | Standard Deviation 31.3 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 48-months | 20.8 score on a scale | Standard Deviation 13.2 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 60-months | 66.0 score on a scale | Standard Deviation 35.4 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 36-months | 5.9 score on a scale | Standard Deviation 9.4 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 60-months | 19.5 score on a scale | Standard Deviation 12.6 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 48-months | 69.3 score on a scale | Standard Deviation 33.7 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 60-months | 6.1 score on a scale | Standard Deviation 9 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 12-months | 6.3 score on a scale | Standard Deviation 9 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 36-months | 67.5 score on a scale | Standard Deviation 33.9 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 60-months | 29.1 score on a scale | Standard Deviation 26.3 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 48-months | 29.5 score on a scale | Standard Deviation 26.3 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 48-months | 5.5 score on a scale | Standard Deviation 8.4 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 12-months | 21.8 score on a scale | Standard Deviation 14.1 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 36-months | 27.5 score on a scale | Standard Deviation 27.1 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Bowel dysfunction at 24-months | 5.7 score on a scale | Standard Deviation 8.2 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 24-months | 20.6 score on a scale | Standard Deviation 13.7 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary incontinence at 24-months | 29.1 score on a scale | Standard Deviation 26.8 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Sexual dysfunction at 24-months | 68.2 score on a scale | Standard Deviation 32.6 |
| Intermediate Risk/Radiation | Prostate Cancer-Specific Health-Related Quality of Life | Urinary obstruction/irritation at 36-months | 19.9 score on a scale | Standard Deviation 13 |
Secondary
Time to Prostate Cancer Recurrence
Time to recurrence represents the period between completion of the first course of treatment (i.e., radiation or surgery) and the date of prostate cancer recurrence (if prostate cancer recurrence occurred).
Time frame: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
Population: Analysis population comprised patients in the National Cancer Data Base, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Prostate cancer recurrence was assessed within each strata by PSA testing frequency. Recurrence data on patients in NC ProCESS were not collected for this assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk/Radiation | Time to Prostate Cancer Recurrence | 2 PSA tests | 5.5 years | Standard Deviation 2.4 |
| Low Risk/Radiation | Time to Prostate Cancer Recurrence | <= 1 PSA test | 4.4 years | Standard Deviation 2.9 |
| Low Risk/Radiation | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 4.8 years | Standard Deviation 2.9 |
| Low Risk/Surgery | Time to Prostate Cancer Recurrence | 2 PSA tests | 2.8 years | Standard Deviation 2.2 |
| Low Risk/Surgery | Time to Prostate Cancer Recurrence | <= 1 PSA test | 3.2 years | Standard Deviation 3.2 |
| Low Risk/Surgery | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 3.4 years | Standard Deviation 2.6 |
| Intermediate Risk/Radiation | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 3.9 years | Standard Deviation 2.2 |
| Intermediate Risk/Radiation | Time to Prostate Cancer Recurrence | <= 1 PSA test | 4.4 years | Standard Deviation 2.8 |
| Intermediate Risk/Radiation | Time to Prostate Cancer Recurrence | 2 PSA tests | 4.5 years | Standard Deviation 2.4 |
| Intermediate Risk/Surgery | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 3.7 years | Standard Deviation 2.4 |
| Intermediate Risk/Surgery | Time to Prostate Cancer Recurrence | 2 PSA tests | 3.2 years | Standard Deviation 2.4 |
| Intermediate Risk/Surgery | Time to Prostate Cancer Recurrence | <= 1 PSA test | 3.3 years | Standard Deviation 2.7 |
| High Risk/Radiation | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 4.1 years | Standard Deviation 2.6 |
| High Risk/Radiation | Time to Prostate Cancer Recurrence | <= 1 PSA test | 3.5 years | Standard Deviation 2.7 |
| High Risk/Radiation | Time to Prostate Cancer Recurrence | 2 PSA tests | 3.8 years | Standard Deviation 2.2 |
| High Risk/Surgery | Time to Prostate Cancer Recurrence | <= 1 PSA test | 2.7 years | Standard Deviation 2.5 |
| High Risk/Surgery | Time to Prostate Cancer Recurrence | >= 3 PSA tests | 2.9 years | Standard Deviation 2.3 |
| High Risk/Surgery | Time to Prostate Cancer Recurrence | 2 PSA tests | 3.2 years | Standard Deviation 2.6 |
Secondary
Treatment for Prostate Cancer Recurrence
Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation.
Time frame: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
Population: Analysis population comprised patients in the National Cancer Data Base with prostate cancer recurrence, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Treatment for recurrence was assessed within each strata by PSA testing frequency. Data on patients in NC ProCESS were not collected for this assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Risk/Radiation | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 71.4 percentage of men with recurrence |
| Low Risk/Radiation | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 68.8 percentage of men with recurrence |
| Low Risk/Radiation | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 63.2 percentage of men with recurrence |
| Low Risk/Surgery | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 91.3 percentage of men with recurrence |
| Low Risk/Surgery | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 88.7 percentage of men with recurrence |
| Low Risk/Surgery | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 84.4 percentage of men with recurrence |
| Intermediate Risk/Radiation | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 72.8 percentage of men with recurrence |
| Intermediate Risk/Radiation | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 74.2 percentage of men with recurrence |
| Intermediate Risk/Radiation | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 77.6 percentage of men with recurrence |
| Intermediate Risk/Surgery | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 88.3 percentage of men with recurrence |
| Intermediate Risk/Surgery | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 94.7 percentage of men with recurrence |
| Intermediate Risk/Surgery | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 89.6 percentage of men with recurrence |
| High Risk/Radiation | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 83.0 percentage of men with recurrence |
| High Risk/Radiation | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 72.8 percentage of men with recurrence |
| High Risk/Radiation | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 83.8 percentage of men with recurrence |
| High Risk/Surgery | Treatment for Prostate Cancer Recurrence | 2 PSA tests | 92.6 percentage of men with recurrence |
| High Risk/Surgery | Treatment for Prostate Cancer Recurrence | <= 1 PSA test | 94.2 percentage of men with recurrence |
| High Risk/Surgery | Treatment for Prostate Cancer Recurrence | >= 3 PSA tests | 94.9 percentage of men with recurrence |