Prostate Cancer
Conditions
Brief summary
This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.
Detailed description
Prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most common cause of cancer death in U.S. men. Technological advances have enabled new treatment options, such as stereotactic body radiation therapy (SBRT) and partial gland ablation (PGA). Although heavily marketed as more convenient with fewer side effects, there is an absence of high-level, comparative effective research (CER) to discern relative outcomes to traditional therapies such as active surveillance (AS), radical prostatectomy (RP) and intensity modulated radiation therapy (IMRT). Investigators hypothesize that PGA will be associated with less reduction of urinary and sexual function compared to before treatment than both RP and IMRT. SBRT is hypothesized to be associated with less reduction of urinary and sexual function before treatment compared to RP and IMRT. SBRT is hypothesized to be associated with less reduction in bowel function compared to IMRT. PGA hypothesized to be associated with better overall quality of life at 12 months compared to AS. Investigators hypothesize PGA and SBRT will be associated with fewer adverse events compared to RP and IMRT. The investigators will conduct a pragmatic, population-based cohort study of men with newly diagnosed low and intermediate risk prostate cancer in Southern California (SCa) and New York State (NYS) Surveillance Epidemiology and End Results (SEER) regions to bridge the evidence gap concerning adverse events and patient reported outcomes. This study will inform multiple stakeholders, who contributed to the study design. Stakeholders include prostate cancer survivors, payers, medical device manufacturers, professional organizations, community and academic prostate cancer experts and the Food and Drug Administration (FDA).
Interventions
OTHERPatient-reported questionnaire
Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Sponsors
Patient-Centered Outcomes Research Institute
Weill Medical College of Cornell University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA \<10 ng/mL) or intermediate risk (T2b-T2c or, Gleason 7, Grade Group 2 or 3 or PSA 10-20 ng/mL)72 at one of the selected hospitals in SCa and NYS * Diagnosis date during the 18 month recruitment window * Able to read/speak English or Spanish * Agree to participate by completing the baseline questionnaire
Exclusion criteria
* Clinically metastatic disease or high-risk PCa (T3a-T4, Gleason Grade Group 4 or 5 or PSA \>20 ng/mL * Unable to read/speak English or Spanish * Unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 8 months | All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. |
| Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 months, 12 months | Adjusted quality of life scores for active surveillance (AS), radical prostatectomy (RP) and partial gland ablation (PGA) at 8 and 12 months showing the mean reported score on a scale from 0-100 with a higher score indicating better function or better health. |
| Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 months, 12 months | The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire, dichotomized by severity, assessing four domains: urinary, sexual, bowel, and hormonal function. Each domain is scored 0-100, with higher scores indicating greater dysfunction. |
| Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 months, 12 months | The Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) is a 4-item questionnaire measuring severity of ejaculatory dysfunction. The 4 items are degree of bother, ejaculatory force, ejaculatory volume, and frequency of ejaculation, and the total score is measured on a scale of 1-20, with higher scores indicating greater dysfunction. Scores were adjusted for age, race (Black, white or other), number of comorbidities (0, 1, 2, \>= 3) and NCCN risk (low vs intermediate). |
| Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 12 months | The Memorial Anxiety Scores for Prostate Cancer (MAX-PC) is an 18-item questionnaire measuring treatment anxiety. Total scores ranged from 0-54, with higher scores associated with higher anxiety, the mean of patient reported MAX-PC scores by treatment group are shown below. |
| Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 8 months | Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results. Information below reflects the percentage of subjects that were estimated to have risk of recurrence based on their reported PSA by treatment group. |
| Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 8 months | Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret. All items are scored 0-100, with higher scores indicating greater treatment regret. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Surveillance (AS) Doctor will monitor the patient without directly treating the cancer.
Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 625 |
| Stereotactic Body Radiation Therapy (SBRT) Radiation treatment of prostate cancer requiring less than 2 weeks of treatment.
Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 226 |
| Intensity-Modulated Radiation Therapy (IMRT) Radiation treatment of prostate cancer requiring more than 2 weeks of treatment.
Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 218 |
| Partial Gland Ablation (PGA) Prostate cancer treatment that involves only treating part of the prostate that has cancer. Examples include, but are not limited to, high intensity focused ultrasound (HIFU) and cryotherapy.
Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 139 |
| Radical Prostatectomy (RP) Prostate surgery that removes the whole prostate.
Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 745 |
| Total | 1,953 |
Baseline characteristics
| Characteristic | Partial Gland Ablation (PGA) | Active Surveillance (AS) | Stereotactic Body Radiation Therapy (SBRT) | Intensity-Modulated Radiation Therapy (IMRT) | Radical Prostatectomy (RP) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69 years | 67 years | 70 years | 71 years | 64 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 37 Participants | 8 Participants | 12 Participants | 66 Participants | 137 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 563 Participants | 211 Participants | 193 Participants | 659 Participants | 1749 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 25 Participants | 7 Participants | 13 Participants | 20 Participants | 67 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 24 Participants | 7 Participants | 7 Participants | 34 Participants | 77 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 55 Participants | 15 Participants | 34 Participants | 93 Participants | 205 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 0 Participants | 0 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 121 Participants | 538 Participants | 204 Participants | 177 Participants | 603 Participants | 1643 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 139 Participants | 625 Participants | 226 Participants | 218 Participants | 745 Participants | 1953 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 625 | 0 / 226 | 0 / 218 | 0 / 139 | 0 / 745 |
| other Total, other adverse events | 55 / 625 | 22 / 226 | 19 / 218 | 32 / 139 | 150 / 745 |
| serious Total, serious adverse events | 0 / 625 | 0 / 226 | 0 / 218 | 0 / 139 | 0 / 745 |
Outcome results
Primary
Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated.
Time frame: 12 months
Population: subjects who returned 12 month surveys are included in the overall number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance (AS) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6.5 percentage of participants |
| Stereotactic Body Radiation Therapy (SBRT) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6.8 percentage of participants |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6.5 percentage of participants |
| Partial Gland Ablation (PGA) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 16 percentage of participants |
| Radical Prostatectomy (RP) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 12 percentage of participants |
Primary
Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated.
Time frame: 8 months
Population: Only subjects who returned 8 month surveys are included in the overall number of participants analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance (AS) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 4.1 percentage of participants |
| Stereotactic Body Radiation Therapy (SBRT) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 4.3 percentage of participants |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 4.1 percentage of participants |
| Partial Gland Ablation (PGA) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 10 percentage of participants |
| Radical Prostatectomy (RP) | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 7.6 percentage of participants |
Primary
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results. Information below reflects the percentage of subjects that were estimated to have risk of recurrence based on their reported PSA by treatment group.
Time frame: 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance (AS) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 4.9 percentage of participants |
| Stereotactic Body Radiation Therapy (SBRT) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 2.1 percentage of participants |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 4.1 percentage of participants |
| Partial Gland Ablation (PGA) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 7.4 percentage of participants |
| Radical Prostatectomy (RP) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 4.3 percentage of participants |
Primary
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results. Information below reflects the percentage of subjects that were estimated to have risk of recurrence based on their reported PSA by treatment group.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance (AS) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 15 percentage of participants |
| Stereotactic Body Radiation Therapy (SBRT) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 6.6 percentage of participants |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 12 percentage of participants |
| Partial Gland Ablation (PGA) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 21 percentage of participants |
| Radical Prostatectomy (RP) | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 13 percentage of participants |
Primary
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret. All items are scored 0-100, with higher scores indicating greater treatment regret.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Surveillance (AS) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 12 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 9.5 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 9.5 score on a scale |
| Partial Gland Ablation (PGA) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 10 score on a scale |
| Radical Prostatectomy (RP) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 14 score on a scale |
Primary
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret. All items are scored 0-100, with higher scores indicating greater treatment regret.
Time frame: 8 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Surveillance (AS) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 13 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 9.3 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 11 score on a scale |
| Partial Gland Ablation (PGA) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 10 score on a scale |
| Radical Prostatectomy (RP) | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 14 score on a scale |
Primary
Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD)
The Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) is a 4-item questionnaire measuring severity of ejaculatory dysfunction. The 4 items are degree of bother, ejaculatory force, ejaculatory volume, and frequency of ejaculation, and the total score is measured on a scale of 1-20, with higher scores indicating greater dysfunction. Scores were adjusted for age, race (Black, white or other), number of comorbidities (0, 1, 2, \>= 3) and NCCN risk (low vs intermediate).
Time frame: 8 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Surveillance (AS) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 Months | 10 score on a scale |
| Active Surveillance (AS) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 12 Months | 10 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 Months | 12 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 12 Months | 12 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 Months | 13 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 12 Months | 13 score on a scale |
| Partial Gland Ablation (PGA) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 12 Months | 12 score on a scale |
| Partial Gland Ablation (PGA) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 Months | 11 score on a scale |
| Radical Prostatectomy (RP) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 8 Months | 15 score on a scale |
| Radical Prostatectomy (RP) | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 12 Months | 15 score on a scale |
Primary
Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L
Adjusted quality of life scores for active surveillance (AS), radical prostatectomy (RP) and partial gland ablation (PGA) at 8 and 12 months showing the mean reported score on a scale from 0-100 with a higher score indicating better function or better health.
Time frame: 8 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Surveillance (AS) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 Months | 0.87 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 12 Months | 0.88 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 Months | 0.88 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 12 Months | 0.89 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 Months | 0.86 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 12 Months | 0.87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 12 Months | 0.88 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 Months | 0.89 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 8 Months | 0.89 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 12 Months | 0.89 score on a scale |
Primary
Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26)
The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire, dichotomized by severity, assessing four domains: urinary, sexual, bowel, and hormonal function. Each domain is scored 0-100, with higher scores indicating greater dysfunction.
Time frame: 8 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Sexual Function | 57 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Hormone Function | 82 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Function | 83 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Incontinence | 82 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Irritation | 84 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Hormone Function | 82 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Bowel Function | 94 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Incontinence | 83 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Irritation | 84 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Sexual Function | 57 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Function | 83 score on a scale |
| Active Surveillance (AS) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Bowel Function | 94 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Hormone Function | 81 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Irritation | 87 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Function | 87 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Sexual Function | 52 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Function | 84 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Hormone Function | 80 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Incontinence | 86 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Sexual Function | 53 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Bowel Function | 94 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Incontinence | 86 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Bowel Function | 91 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Irritation | 83 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Hormone Function | 81 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Function | 83 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Function | 87 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Incontinence | 84 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Incontinence | 85 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Irritation | 83 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Irritation | 88 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Sexual Function | 48 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Sexual Function | 53 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Bowel Function | 90 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Bowel Function | 93 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Hormone Function | 84 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Irritation | 88 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Function | 87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Sexual Function | 56 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Irritation | 87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Bowel Function | 95 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Incontinence | 87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Hormone Function | 83 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Bowel Function | 96 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Incontinence | 87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Function | 87 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Hormone Function | 85 score on a scale |
| Partial Gland Ablation (PGA) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Sexual Function | 55 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Irritation | 88 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Bowel Function | 95 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Function | 77 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Sexual Function | 40 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Function | 80 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Urinary Incontinence | 72 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 12 Months Hormone Function | 82 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Irritation | 86 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Bowel Function | 94 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Sexual Function | 36 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Urinary Incontinence | 67 score on a scale |
| Radical Prostatectomy (RP) | Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26) | 8 Months Hormone Function | 81 score on a scale |
Primary
Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC)
The Memorial Anxiety Scores for Prostate Cancer (MAX-PC) is an 18-item questionnaire measuring treatment anxiety. Total scores ranged from 0-54, with higher scores associated with higher anxiety, the mean of patient reported MAX-PC scores by treatment group are shown below.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Surveillance (AS) | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 16 score on a scale |
| Stereotactic Body Radiation Therapy (SBRT) | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 15 score on a scale |
| Intensity-Modulated Radiation Therapy (IMRT) | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 15 score on a scale |
| Partial Gland Ablation (PGA) | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 14 score on a scale |
| Radical Prostatectomy (RP) | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 15 score on a scale |