Trial Outcomes & Findings for Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment (NCT NCT04890314)

Results Overview

All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated.

Recruitment status

COMPLETED

Target enrollment

1953 participants

Primary outcome timeframe

8 months

Results posted on

2025-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	625	226	218	139	745
Overall Study COMPLETED	625	226	218	139	745
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.	Total n=1953 Participants Total of all reporting groups
Age, Continuous	67 years n=93 Participants	70 years n=4 Participants	71 years n=27 Participants	69 years n=483 Participants	64 years n=36 Participants	68 years n=10 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	625 Participants n=93 Participants	226 Participants n=4 Participants	218 Participants n=27 Participants	139 Participants n=483 Participants	745 Participants n=36 Participants	1953 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants	14 Participants n=483 Participants	66 Participants n=36 Participants	137 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	563 Participants n=93 Participants	211 Participants n=4 Participants	193 Participants n=27 Participants	123 Participants n=483 Participants	659 Participants n=36 Participants	1749 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants	2 Participants n=483 Participants	20 Participants n=36 Participants	67 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Asian	24 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	5 Participants n=483 Participants	34 Participants n=36 Participants	77 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Black or African American	55 Participants n=93 Participants	15 Participants n=4 Participants	34 Participants n=27 Participants	8 Participants n=483 Participants	93 Participants n=36 Participants	205 Participants n=10 Participants
Race (NIH/OMB) White	538 Participants n=93 Participants	204 Participants n=4 Participants	177 Participants n=27 Participants	121 Participants n=483 Participants	603 Participants n=36 Participants	1643 Participants n=10 Participants
Race (NIH/OMB) More than one race	4 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants	11 Participants n=36 Participants	20 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: 8 months

Population: Only subjects who returned 8 month surveys are included in the overall number of participants analyzed.

All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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 Interval 2.1 to 6.0	4.3 percentage of participants Interval 0.9 to 7.6	4.1 percentage of participants Interval 0.5 to 7.7	10 percentage of participants Interval 3.7 to 16.0	7.6 percentage of participants Interval 5.2 to 10.0

PRIMARY outcome

Timeframe: 12 months

Population: subjects who returned 12 month surveys are included in the overall number of participants analyzed.

All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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 Interval 3.4 to 9.6	6.8 percentage of participants Interval 1.3 to 12.0	6.5 percentage of participants Interval 0.6 to 12.0	16 percentage of participants Interval 5.9 to 25.0	12 percentage of participants Interval 7.9 to 16.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L 12 Months	0.88 score on a scale Interval 0.86 to 0.89	0.89 score on a scale Interval 0.86 to 0.92	0.87 score on a scale Interval 0.84 to 0.89	0.88 score on a scale Interval 0.85 to 0.91	0.89 score on a scale Interval 0.87 to 0.91
Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L 8 Months	0.87 score on a scale Interval 0.85 to 0.89	0.88 score on a scale Interval 0.85 to 0.9	0.86 score on a scale Interval 0.83 to 0.88	0.89 score on a scale Interval 0.86 to 0.91	0.89 score on a scale Interval 0.87 to 0.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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 Interval 80.0 to 85.0	81 score on a scale Interval 76.0 to 85.0	84 score on a scale Interval 80.0 to 88.0	83 score on a scale Interval 77.0 to 88.0	82 score on a scale Interval 79.0 to 84.0
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 Interval 81.0 to 85.0	84 score on a scale Interval 82.0 to 87.0	83 score on a scale Interval 81.0 to 85.0	87 score on a scale Interval 84.0 to 89.0	77 score on a scale Interval 75.0 to 78.0
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 Interval 81.0 to 85.0	87 score on a scale Interval 84.0 to 90.0	87 score on a scale Interval 83.0 to 90.0	87 score on a scale Interval 84.0 to 91.0	80 score on a scale Interval 79.0 to 82.0
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 Interval 80.0 to 86.0	86 score on a scale Interval 83.0 to 90.0	84 score on a scale Interval 80.0 to 87.0	87 score on a scale Interval 83.0 to 91.0	67 score on a scale Interval 64.0 to 69.0
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 Interval 80.0 to 85.0	86 score on a scale Interval 81.0 to 91.0	85 score on a scale Interval 80.0 to 91.0	87 score on a scale Interval 82.0 to 92.0	72 score on a scale Interval 69.0 to 75.0
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 Interval 83.0 to 86.0	83 score on a scale Interval 81.0 to 85.0	83 score on a scale Interval 81.0 to 86.0	87 score on a scale Interval 85.0 to 90.0	86 score on a scale Interval 85.0 to 88.0
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 Interval 83.0 to 86.0	87 score on a scale Interval 84.0 to 90.0	88 score on a scale Interval 85.0 to 92.0	88 score on a scale Interval 85.0 to 91.0	88 score on a scale Interval 86.0 to 90.0
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 Interval 53.0 to 60.0	52 score on a scale Interval 47.0 to 57.0	48 score on a scale Interval 44.0 to 53.0	55 score on a scale Interval 49.0 to 60.0	36 score on a scale Interval 32.0 to 39.0
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 Interval 54.0 to 60.0	53 score on a scale Interval 47.0 to 59.0	53 score on a scale Interval 47.0 to 58.0	56 score on a scale Interval 49.0 to 63.0	40 score on a scale Interval 36.0 to 43.0
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 Interval 92.0 to 95.0	91 score on a scale Interval 89.0 to 93.0	90 score on a scale Interval 88.0 to 92.0	95 score on a scale Interval 93.0 to 97.0	94 score on a scale Interval 93.0 to 95.0
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 Interval 93.0 to 95.0	94 score on a scale Interval 91.0 to 96.0	93 score on a scale Interval 90.0 to 96.0	96 score on a scale Interval 93.0 to 98.0	95 score on a scale Interval 94.0 to 97.0
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 Interval 80.0 to 84.0	80 score on a scale Interval 77.0 to 83.0	81 score on a scale Interval 78.0 to 84.0	85 score on a scale Interval 81.0 to 89.0	81 score on a scale Interval 78.0 to 83.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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 Interval 9.6 to 11.0	12 score on a scale Interval 11.0 to 13.0	13 score on a scale Interval 12.0 to 14.0	11 score on a scale Interval 10.0 to 12.0	15 score on a scale Interval 14.0 to 16.0
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 Interval 9.8 to 11.0	12 score on a scale Interval 11.0 to 13.0	13 score on a scale Interval 12.0 to 14.0	12 score on a scale Interval 11.0 to 13.0	15 score on a scale Interval 14.0 to 16.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC)	16 score on a scale Interval 15.0 to 17.0	15 score on a scale Interval 13.0 to 17.0	15 score on a scale Interval 13.0 to 17.0	14 score on a scale Interval 12.0 to 16.0	15 score on a scale Interval 14.0 to 16.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels	4.9 percentage of participants Interval 3.0 to 6.8	2.1 percentage of participants Interval 0.4 to 3.9	4.1 percentage of participants Interval 1.4 to 6.9	7.4 percentage of participants Interval 3.2 to 11.0	4.3 percentage of participants Interval 2.6 to 6.0

PRIMARY outcome

Timeframe: 12 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels	15 percentage of participants Interval 9.7 to 19.0	6.6 percentage of participants Interval 1.0 to 12.0	12 percentage of participants Interval 4.1 to 21.0	21 percentage of participants Interval 9.0 to 34.0	13 percentage of participants Interval 8.6 to 17.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Surveillance (AS) n=625 Participants 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.	Stereotactic Body Radiation Therapy (SBRT) n=226 Participants 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.	Intensity-Modulated Radiation Therapy (IMRT) n=218 Participants 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.	Partial Gland Ablation (PGA) n=139 Participants 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.	Radical Prostatectomy (RP) n=745 Participants Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry	13 score on a scale Interval 11.0 to 15.0	9.3 score on a scale Interval 6.6 to 12.0	11 score on a scale Interval 7.5 to 14.0	10 score on a scale Interval 6.7 to 13.0	14 score on a scale Interval 12.0 to 16.0

PRIMARY outcome

Timeframe: 12 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.