Cancer of the Prostate, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer, Prostatic Neoplasms
Conditions
Keywords
Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Prostate Tumor, Prostate Surgery
Brief summary
The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.
Detailed description
In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues. The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Interventions
RADIATIONCyberKnife Stereotactic Radiosurgery - Low Risk
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate
RADIATIONCyberKnife Stereotactic Radiosurgery - Intermediate Risk
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally
Sponsors
Accuray Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Histologically proven prostate adenocarcinoma * Biopsy within 1 year of date of registration * Clinical Stage (CS) T1b-T2b, N0, M0 * Patients belonging to one of the following risk categories: * Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) \< or = 10 ng/ml * Intermediate Risk: CS T2b, Gleason Score 2-6, PSA \< or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA \< or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA \< or = 10 ng/ml * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion criteria
* Clinical Stage T2c or greater * Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy of the prostate or lower pelvis * Implanted hardware or other material that would prohibit appropriate treatment planning or delivery * History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years * Hormone ablation for two months prior to enrollment or during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed in both low-risk and intermediate-risk cohorts during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event. |
| Biochemical Disease-Free Survival (bDFS) | Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Disease Control and Survival Outcomes | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. |
| Quality of Life Assessments: EPIC-26 Sexual | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: EPIC-26 Bowel | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. | EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided. |
| Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 5 years. Sites and patients had the option of continuing follow-up through 10 years. | AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always) Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms |
Countries
United States
Participant flow
Recruitment details
From October 2007 through December 2011, 307 subjects signed informed consent and were enrolled in the study at 18 centers in the United States.
Pre-assignment details
Of these 307 subjects, 48 patients did not receive study treatment and were withdrawn from the study. Reasons for withdrawal included meeting exclusion criteria after central pathology review, insurance did not approve participation in a clinical study, or patient decision to withdraw prior to receiving treatment. 259 subjects were assigned to either the Low Risk or Intermediate Risk groups after central pathology review results.
Participants by arm
| Arm | Count |
|---|---|
| CyberKnife Stereotactic Radiosurgery - Low Risk 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate | 112 |
| CyberKnife Stereotactic Radiosurgery - Intermediate Risk 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally | 147 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 9 |
| Overall Study | Lost to Follow-up | 42 | 51 |
Baseline characteristics
| Characteristic | CyberKnife Stereotactic Radiosurgery - Low Risk | Total | CyberKnife Stereotactic Radiosurgery - Intermediate Risk |
|---|---|---|---|
| Age, Continuous | 67.2 years | 67.8 years | 68.4 years |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml | 0 Participants | 9 Participants | 9 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml | 0 Participants | 136 Participants | 136 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml | 0 Participants | 2 Participants | 2 Participants |
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group Low: CS T1b-T2a, Gleason 2-6, PSA ≤ 10 ng/ml | 112 Participants | 112 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction | 109 Participants | 246 Participants | 137 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = Restricted in physically strenuous activity | 2 Participants | 11 Participants | 9 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = Capable of all selfcare but unable to carry out any work activities | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = Capable of only limited selfcare | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Unreported | 1 Participants | 2 Participants | 1 Participants |
| Prostate Specific Antigen (PSA) | 4.72 ng/mL | 5.6 ng/mL | 6.31 ng/mL |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 13 Participants | 12 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 105 Participants | 232 Participants | 127 Participants |
| Region of Enrollment United States | 112 Participants | 259 Participants | 147 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 112 Participants | 259 Participants | 147 Participants |
| Total Gleason Score Gleason 2 - 6 | 112 Participants | 123 Participants | 11 Participants |
| Total Gleason Score Gleason 7 | 0 Participants | 136 Participants | 136 Participants |
| Tumor Clinical Stage (CS) T1b = Tumor incidental histological finding in >5% of tissue resected | 0 Participants | 0 Participants | 0 Participants |
| Tumor Clinical Stage (CS) T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable | 85 Participants | 183 Participants | 98 Participants |
| Tumor Clinical Stage (CS) T2a = Tumor involves ½ of one side or less | 27 Participants | 73 Participants | 46 Participants |
| Tumor Clinical Stage (CS) T2b = Tumor involves >½ of one side but not both sides | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 112 | 14 / 147 |
| other Total, other adverse events | 103 / 112 | 142 / 147 |
| serious Total, serious adverse events | 17 / 112 | 25 / 147 |
Outcome results
Primary
Biochemical Disease-Free Survival (bDFS)
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
Time frame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Risk | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Intermediate Risk | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 5 years post-CyberKnife treatment | 89.1 percentage of participants |
| Intermediate Risk | Biochemical Disease-Free Survival (bDFS) | Probability of remaining disease-free at 10 years post-CyberKnife treatment | 80 percentage of participants |
Primary
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed in both low-risk and intermediate-risk cohorts during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Time frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GU Grade 3+ event(s) | 1.8 percentage of participants |
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ events 5 years post treatment | 1.0 percentage of participants |
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GI Grade 3+ event(s) | 0 percentage of participants |
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment | 0 percentage of participants |
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment | 1.0 percentage of participants |
| Low Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ events 5 years post treatment | 0 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment | 3.7 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment | 0 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GI Grade 3+ event(s) | 0 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Acute GU Grade 3+ event(s) | 0.7 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GI Grade 3+ events 5 years post treatment | 0 percentage of participants |
| Intermediate Risk | Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity | Probability of experiencing Late GU Grade 3+ events 5 years post treatment | 3.7 percentage of participants |
Secondary
Disease Control and Survival Outcomes
To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from disease at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of remaining free from disease at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of surviving prostate cancer at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of surviving prostate cancer at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of Overall survival at 5 years post-CyberKnife treatment | 95.4 percentage of participants |
| Low Risk | Disease Control and Survival Outcomes | Probability of Overall survival at 10 years post-CyberKnife treatment | 83.8 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of surviving prostate cancer at 10 years post-CyberKnife treatment | 100 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment | 98.3 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from disease at 10 years post-CyberKnife treatment | 80 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment | 98.3 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of Overall survival at 10 years post-CyberKnife treatment | 86.4 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment | 95 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of surviving prostate cancer at 5 years post-CyberKnife treatment | 100 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment | 95 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of Overall survival at 5 years post-CyberKnife treatment | 91.7 percentage of participants |
| Intermediate Risk | Disease Control and Survival Outcomes | Probability of remaining free from disease at 5 years post-CyberKnife treatment | 89.1 percentage of participants |
Secondary
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always) Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms
Time frame: AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: AUA questionnaires were to be completed by patients for each follow-up visit. All questions need to be completed in order to calculate the score. During follow-up, patients may have withdrawn from the study, did not consent to continue follow-up through 10 years, were lost to follow-up, decided not to complete a questionnaire, or did not fully complete a questionnaire. Scores were calculated on fully completed questionnaires even if received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 108 Months Post Treatment | 8.00 score on a scale | Standard Deviation 7.35 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Baseline | 7.05 score on a scale | Standard Deviation 6.32 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Last Day of Treatment | 9.49 score on a scale | Standard Deviation 7.53 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Week Post Treatment | 13.57 score on a scale | Standard Deviation 9.17 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Month Post Treatment | 11.00 score on a scale | Standard Deviation 7.3 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 3 Months Post Treatment | 7.09 score on a scale | Standard Deviation 5.55 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 6 Months Post Treatment | 7.78 score on a scale | Standard Deviation 7.1 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 12 Months Post Treatment | 8.39 score on a scale | Standard Deviation 6.69 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 18 Months Post Treatment | 8.39 score on a scale | Standard Deviation 6.9 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 24 Months Post Treatment | 7.80 score on a scale | Standard Deviation 6.88 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 36 Months Post Treatment | 7.25 score on a scale | Standard Deviation 7.06 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 48 Months Post Treatment | 6.69 score on a scale | Standard Deviation 6.73 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 60 Months Post Treatment | 7.23 score on a scale | Standard Deviation 7.15 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 72 Months Post Treatment | 7.81 score on a scale | Standard Deviation 7.04 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 84 Months Post Treatment | 7.59 score on a scale | Standard Deviation 6.28 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 96 Months Post Treatment | 8.76 score on a scale | Standard Deviation 8.05 |
| Low Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 120 Months Post Treatment | 7.94 score on a scale | Standard Deviation 7.41 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 72 Months Post Treatment | 8.16 score on a scale | Standard Deviation 7.56 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 24 Months Post Treatment | 9.47 score on a scale | Standard Deviation 7.53 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Baseline | 7.12 score on a scale | Standard Deviation 5.79 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 108 Months Post Treatment | 8.75 score on a scale | Standard Deviation 6.6 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | Last Day of Treatment | 8.64 score on a scale | Standard Deviation 7.14 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 36 Months Post Treatment | 7.88 score on a scale | Standard Deviation 6.62 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Week Post Treatment | 14.14 score on a scale | Standard Deviation 8.85 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 84 Months Post Treatment | 9.84 score on a scale | Standard Deviation 8.53 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 1 Month Post Treatment | 10.74 score on a scale | Standard Deviation 6.91 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 48 Months Post Treatment | 7.97 score on a scale | Standard Deviation 6.01 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 3 Months Post Treatment | 7.26 score on a scale | Standard Deviation 5.88 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 120 Months Post Treatment | 8.69 score on a scale | Standard Deviation 6.89 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 6 Months Post Treatment | 8.09 score on a scale | Standard Deviation 6.51 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 60 Months Post Treatment | 9.19 score on a scale | Standard Deviation 7.03 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 12 Months Post Treatment | 10.05 score on a scale | Standard Deviation 7.23 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 96 Months Post Treatment | 8.64 score on a scale | Standard Deviation 6.83 |
| Intermediate Risk | Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) | 18 Months Post Treatment | 10.24 score on a scale | Standard Deviation 8.22 |
Secondary
Quality of Life Assessments: EPIC-26 Bowel
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 6 Months Post Treatment | 93.45 score on a scale | Standard Deviation 12.06 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 60 Months Post Treatment | 94.49 score on a scale | Standard Deviation 11.67 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 24 Months Post Treatment | 93.68 score on a scale | Standard Deviation 11.16 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 72 Months Post Treatment | 94.3 score on a scale | Standard Deviation 10.98 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 1 Month Post Treatment | 89.32 score on a scale | Standard Deviation 14.63 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 84 Months Post Treatment | 92.42 score on a scale | Standard Deviation 11.31 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 36 Months Post Treatment | 94.82 score on a scale | Standard Deviation 9.27 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 96 Months Post Treatment | 91.67 score on a scale | Standard Deviation 14.22 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 12 Months Post Treatment | 93.51 score on a scale | Standard Deviation 11.41 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 108 Months Post Treatment | 90.07 score on a scale | Standard Deviation 12.56 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 48 Months Post Treatment | 94.65 score on a scale | Standard Deviation 9.77 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | 120 Months Post Treatment | 91.17 score on a scale | Standard Deviation 13.07 |
| Low Risk | Quality of Life Assessments: EPIC-26 Bowel | Baseline | 96.25 score on a scale | Standard Deviation 8.14 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 120 Months Post Treatment | 93.59 score on a scale | Standard Deviation 11.07 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | Baseline | 94.84 score on a scale | Standard Deviation 9.96 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 1 Month Post Treatment | 86.05 score on a scale | Standard Deviation 16.66 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 6 Months Post Treatment | 89.92 score on a scale | Standard Deviation 15.91 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 12 Months Post Treatment | 87.97 score on a scale | Standard Deviation 17.42 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 24 Months Post Treatment | 89.28 score on a scale | Standard Deviation 17.26 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 36 Months Post Treatment | 93.29 score on a scale | Standard Deviation 12.48 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 48 Months Post Treatment | 92.04 score on a scale | Standard Deviation 12.28 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 60 Months Post Treatment | 91.03 score on a scale | Standard Deviation 15.38 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 72 Months Post Treatment | 89.54 score on a scale | Standard Deviation 17.07 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 84 Months Post Treatment | 90.49 score on a scale | Standard Deviation 16.09 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 96 Months Post Treatment | 91.27 score on a scale | Standard Deviation 13.73 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Bowel | 108 Months Post Treatment | 91.33 score on a scale | Standard Deviation 12.74 |
Secondary
Quality of Life Assessments: EPIC-26 Sexual
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 6 Months Post Treatment | 50.06 score on a scale | Standard Deviation 31.91 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 60 Months Post Treatment | 32.22 score on a scale | Standard Deviation 31.16 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 24 Months Post Treatment | 40.77 score on a scale | Standard Deviation 32.15 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 72 Months Post Treatment | 30.89 score on a scale | Standard Deviation 27.26 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 1 Month Post Treatment | 47.46 score on a scale | Standard Deviation 33.58 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 84 Months Post Treatment | 28.15 score on a scale | Standard Deviation 25.51 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 36 Months Post Treatment | 42.5 score on a scale | Standard Deviation 33.57 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 96 Months Post Treatment | 27.55 score on a scale | Standard Deviation 26.55 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 12 Months Post Treatment | 44.86 score on a scale | Standard Deviation 34.82 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 108 Months Post Treatment | 28.8 score on a scale | Standard Deviation 30.09 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 48 Months Post Treatment | 38.3 score on a scale | Standard Deviation 31.56 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | 120 Months Post Treatment | 23.88 score on a scale | Standard Deviation 23.55 |
| Low Risk | Quality of Life Assessments: EPIC-26 Sexual | Baseline | 55.27 score on a scale | Standard Deviation 33.41 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 120 Months Post Treatment | 33.69 score on a scale | Standard Deviation 30.97 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | Baseline | 56.32 score on a scale | Standard Deviation 32.6 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 1 Month Post Treatment | 50.58 score on a scale | Standard Deviation 31.82 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 6 Months Post Treatment | 51.23 score on a scale | Standard Deviation 33.47 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 12 Months Post Treatment | 45.2 score on a scale | Standard Deviation 32.46 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 24 Months Post Treatment | 39.73 score on a scale | Standard Deviation 30.39 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 36 Months Post Treatment | 40.99 score on a scale | Standard Deviation 31.59 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 48 Months Post Treatment | 38.95 score on a scale | Standard Deviation 31.8 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 60 Months Post Treatment | 36.89 score on a scale | Standard Deviation 32.44 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 72 Months Post Treatment | 33.13 score on a scale | Standard Deviation 29.08 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 84 Months Post Treatment | 35.14 score on a scale | Standard Deviation 29.68 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 96 Months Post Treatment | 34.74 score on a scale | Standard Deviation 30.05 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Sexual | 108 Months Post Treatment | 36.19 score on a scale | Standard Deviation 29.48 |
Secondary
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 6 Months Post Treatment | 86.75 score on a scale | Standard Deviation 14.69 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 60 Months Post Treatment | 87.72 score on a scale | Standard Deviation 14.9 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 24 Months Post Treatment | 86.56 score on a scale | Standard Deviation 15.09 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 72 Months Post Treatment | 85.19 score on a scale | Standard Deviation 13.84 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 1 Month Post Treatment | 74.11 score on a scale | Standard Deviation 17.49 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 84 Months Post Treatment | 87.07 score on a scale | Standard Deviation 13.84 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 36 Months Post Treatment | 86.99 score on a scale | Standard Deviation 15.09 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 96 Months Post Treatment | 85.78 score on a scale | Standard Deviation 14.22 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 12 Months Post Treatment | 83.29 score on a scale | Standard Deviation 15.45 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 108 Months Post Treatment | 85.8 score on a scale | Standard Deviation 14.43 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 48 Months Post Treatment | 87.81 score on a scale | Standard Deviation 13.03 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 120 Months Post Treatment | 85.0 score on a scale | Standard Deviation 17.42 |
| Low Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | Baseline | 87.67 score on a scale | Standard Deviation 13.96 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 120 Months Post Treatment | 86.25 score on a scale | Standard Deviation 11.69 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | Baseline | 87.59 score on a scale | Standard Deviation 12.32 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 1 Month Post Treatment | 74.03 score on a scale | Standard Deviation 17.82 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 6 Months Post Treatment | 82.91 score on a scale | Standard Deviation 17.4 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 12 Months Post Treatment | 80.1 score on a scale | Standard Deviation 18.79 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 24 Months Post Treatment | 81.05 score on a scale | Standard Deviation 18.71 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 36 Months Post Treatment | 85.77 score on a scale | Standard Deviation 16.77 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 48 Months Post Treatment | 84.03 score on a scale | Standard Deviation 16.36 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 60 Months Post Treatment | 84.15 score on a scale | Standard Deviation 14.32 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 72 Months Post Treatment | 87.95 score on a scale | Standard Deviation 13.37 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 84 Months Post Treatment | 83.13 score on a scale | Standard Deviation 20.13 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 96 Months Post Treatment | 84.58 score on a scale | Standard Deviation 14.45 |
| Intermediate Risk | Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive | 108 Months Post Treatment | 82.09 score on a scale | Standard Deviation 15.11 |
Secondary
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Population: EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 6 Months Post Treatment | 92.81 score on a scale | Standard Deviation 14.08 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 60 Months Post Treatment | 89.5 score on a scale | Standard Deviation 18.31 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 24 Months Post Treatment | 87.66 score on a scale | Standard Deviation 17.32 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 72 Months Post Treatment | 87.44 score on a scale | Standard Deviation 19.55 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 1 Month Post Treatment | 90.33 score on a scale | Standard Deviation 14.56 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 84 Months Post Treatment | 86.26 score on a scale | Standard Deviation 19.89 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 36 Months Post Treatment | 90.2 score on a scale | Standard Deviation 19.38 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 96 Months Post Treatment | 86.32 score on a scale | Standard Deviation 18.84 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 12 Months Post Treatment | 90.64 score on a scale | Standard Deviation 17.39 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 108 Months Post Treatment | 84.17 score on a scale | Standard Deviation 23.54 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 48 Months Post Treatment | 88.74 score on a scale | Standard Deviation 20.88 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 120 Months Post Treatment | 87.04 score on a scale | Standard Deviation 18.55 |
| Low Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | Baseline | 95.77 score on a scale | Standard Deviation 10.42 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 120 Months Post Treatment | 78.12 score on a scale | Standard Deviation 26.25 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | Baseline | 91.59 score on a scale | Standard Deviation 14.39 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 1 Month Post Treatment | 88.83 score on a scale | Standard Deviation 16.85 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 6 Months Post Treatment | 88.48 score on a scale | Standard Deviation 16.51 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 12 Months Post Treatment | 85.37 score on a scale | Standard Deviation 19.23 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 24 Months Post Treatment | 78.44 score on a scale | Standard Deviation 25.72 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 36 Months Post Treatment | 81.08 score on a scale | Standard Deviation 22.8 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 48 Months Post Treatment | 80.62 score on a scale | Standard Deviation 22.11 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 60 Months Post Treatment | 80.04 score on a scale | Standard Deviation 20.8 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 72 Months Post Treatment | 75.17 score on a scale | Standard Deviation 24.86 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 84 Months Post Treatment | 76.43 score on a scale | Standard Deviation 25.68 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 96 Months Post Treatment | 76.79 score on a scale | Standard Deviation 25.46 |
| Intermediate Risk | Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence | 108 Months Post Treatment | 73.72 score on a scale | Standard Deviation 28.88 |