18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0Primary· 8 months
All adverse events will be graded as an event occurred, event will indicate an adverse event occurred.
observations only; intervention not indicated.
Group
Value
95% CI
Active Surveillance (AS)
4.1
2.1 – 6.0
Stereotactic Body Radiation Therapy (SBRT)
4.3
0.9 – 7.6
Intensity-Modulated Radiation Therapy (IMRT)
4.1
0.5 – 7.7
Partial Gland Ablation (PGA)
10
3.7 – 16
Radical Prostatectomy (RP)
7.6
5.2 – 10
Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0Primary· 12 months
All adverse events will be graded as an event occurred, event will indicate an adverse event occurred.
observations only; intervention not indicated.
Group
Value
95% CI
Active Surveillance (AS)
6.5
3.4 – 9.6
Stereotactic Body Radiation Therapy (SBRT)
6.8
1.3 – 12
Intensity-Modulated Radiation Therapy (IMRT)
6.5
0.6 – 12
Partial Gland Ablation (PGA)
16
5.9 – 25
Radical Prostatectomy (RP)
12
7.9 – 16
Change in Patient-Reported Quality of Life as Measured on EQ-5D-5LPrimary· 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.
8 Months
Group
Value
95% CI
Active Surveillance (AS)
0.87
0.85 – 0.89
Stereotactic Body Radiation Therapy (SBRT)
0.88
0.85 – 0.90
Intensity-Modulated Radiation Therapy (IMRT)
0.86
0.83 – 0.88
Partial Gland Ablation (PGA)
0.89
0.86 – 0.91
Radical Prostatectomy (RP)
0.89
0.87 – 0.90
12 Months
Group
Value
95% CI
Active Surveillance (AS)
0.88
0.86 – 0.89
Stereotactic Body Radiation Therapy (SBRT)
0.89
0.86 – 0.92
Intensity-Modulated Radiation Therapy (IMRT)
0.87
0.84 – 0.89
Partial Gland Ablation (PGA)
0.88
0.85 – 0.91
Radical Prostatectomy (RP)
0.89
0.87 – 0.91
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)Primary· 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.
8 Months Urinary Function
Group
Value
95% CI
Active Surveillance (AS)
83
81 – 85
Stereotactic Body Radiation Therapy (SBRT)
84
82 – 87
Intensity-Modulated Radiation Therapy (IMRT)
83
81 – 85
Partial Gland Ablation (PGA)
87
84 – 89
Radical Prostatectomy (RP)
77
75 – 78
12 Months Urinary Function
Group
Value
95% CI
Active Surveillance (AS)
83
81 – 85
Stereotactic Body Radiation Therapy (SBRT)
87
84 – 90
Intensity-Modulated Radiation Therapy (IMRT)
87
83 – 90
Partial Gland Ablation (PGA)
87
84 – 91
Radical Prostatectomy (RP)
80
79 – 82
8 Months Urinary Incontinence
Group
Value
95% CI
Active Surveillance (AS)
83
80 – 86
Stereotactic Body Radiation Therapy (SBRT)
86
83 – 90
Intensity-Modulated Radiation Therapy (IMRT)
84
80 – 87
Partial Gland Ablation (PGA)
87
83 – 91
Radical Prostatectomy (RP)
67
64 – 69
12 Months Urinary Incontinence
Group
Value
95% CI
Active Surveillance (AS)
82
80 – 85
Stereotactic Body Radiation Therapy (SBRT)
86
81 – 91
Intensity-Modulated Radiation Therapy (IMRT)
85
80 – 91
Partial Gland Ablation (PGA)
87
82 – 92
Radical Prostatectomy (RP)
72
69 – 75
8 Months Urinary Irritation
Group
Value
95% CI
Active Surveillance (AS)
84
83 – 86
Stereotactic Body Radiation Therapy (SBRT)
83
81 – 85
Intensity-Modulated Radiation Therapy (IMRT)
83
81 – 86
Partial Gland Ablation (PGA)
87
85 – 90
Radical Prostatectomy (RP)
86
85 – 88
12 Months Urinary Irritation
Group
Value
95% CI
Active Surveillance (AS)
84
83 – 86
Stereotactic Body Radiation Therapy (SBRT)
87
84 – 90
Intensity-Modulated Radiation Therapy (IMRT)
88
85 – 92
Partial Gland Ablation (PGA)
88
85 – 91
Radical Prostatectomy (RP)
88
86 – 90
8 Months Sexual Function
Group
Value
95% CI
Active Surveillance (AS)
57
53 – 60
Stereotactic Body Radiation Therapy (SBRT)
52
47 – 57
Intensity-Modulated Radiation Therapy (IMRT)
48
44 – 53
Partial Gland Ablation (PGA)
55
49 – 60
Radical Prostatectomy (RP)
36
32 – 39
12 Months Sexual Function
Group
Value
95% CI
Active Surveillance (AS)
57
54 – 60
Stereotactic Body Radiation Therapy (SBRT)
53
47 – 59
Intensity-Modulated Radiation Therapy (IMRT)
53
47 – 58
Partial Gland Ablation (PGA)
56
49 – 63
Radical Prostatectomy (RP)
40
36 – 43
Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD)Primary· 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).
8 Months
Group
Value
95% CI
Active Surveillance (AS)
10
9.6 – 11
Stereotactic Body Radiation Therapy (SBRT)
12
11 – 13
Intensity-Modulated Radiation Therapy (IMRT)
13
12 – 14
Partial Gland Ablation (PGA)
11
10 – 12
Radical Prostatectomy (RP)
15
14 – 16
12 Months
Group
Value
95% CI
Active Surveillance (AS)
10
9.8 – 11
Stereotactic Body Radiation Therapy (SBRT)
12
11 – 13
Intensity-Modulated Radiation Therapy (IMRT)
13
12 – 14
Partial Gland Ablation (PGA)
12
11 – 13
Radical Prostatectomy (RP)
15
14 – 16
Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC)Primary· 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.
Group
Value
95% CI
Active Surveillance (AS)
16
15 – 17
Stereotactic Body Radiation Therapy (SBRT)
15
13 – 17
Intensity-Modulated Radiation Therapy (IMRT)
15
13 – 17
Partial Gland Ablation (PGA)
14
12 – 16
Radical Prostatectomy (RP)
15
14 – 16
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen LevelsPrimary· 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.
Group
Value
95% CI
Active Surveillance (AS)
4.9
3.0 – 6.8
Stereotactic Body Radiation Therapy (SBRT)
2.1
0.4 – 3.9
Intensity-Modulated Radiation Therapy (IMRT)
4.1
1.4 – 6.9
Partial Gland Ablation (PGA)
7.4
3.2 – 11
Radical Prostatectomy (RP)
4.3
2.6 – 6.0
Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen LevelsPrimary· 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.
Group
Value
95% CI
Active Surveillance (AS)
15
9.7 – 19
Stereotactic Body Radiation Therapy (SBRT)
6.6
1.0 – 12
Intensity-Modulated Radiation Therapy (IMRT)
12
4.1 – 21
Partial Gland Ablation (PGA)
21
9.0 – 34
Radical Prostatectomy (RP)
13
8.6 – 17
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health WorryPrimary· 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.
Group
Value
95% CI
Active Surveillance (AS)
13
11 – 15
Stereotactic Body Radiation Therapy (SBRT)
9.3
6.6 – 12
Intensity-Modulated Radiation Therapy (IMRT)
11
7.5 – 14
Partial Gland Ablation (PGA)
10
6.7 – 13
Radical Prostatectomy (RP)
14
12 – 16
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health WorryPrimary· 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.
Group
Value
95% CI
Active Surveillance (AS)
12
10 – 14
Stereotactic Body Radiation Therapy (SBRT)
9.5
5.9 – 13
Intensity-Modulated Radiation Therapy (IMRT)
9.5
5.0 – 14
Partial Gland Ablation (PGA)
10
5.4 – 15
Radical Prostatectomy (RP)
14
12 – 16
Adverse events — posted to ClinicalTrials.gov
Time frame: The occurrence of treatment complications indicating an adverse event were patient-reported complications based on survey questions asked on both month 8 and month 12 surveys..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 22 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04890314.