N/A
Completed N=1,953
Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment
Source: ClinicalTrials.gov NCT04890314 ↗Enrolled (actual)
1,953
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 — 4.1; 4.3; 4.1; 10 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
6.5; 6.8; 6.5; 16; 12 | — |
| PRIMARY Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L |
0.87; 0.88; 0.86; 0.89; 0.89; 0.88 | — |
| 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) |
83; 84; 83; 87; 77; 83 | — |
| PRIMARY Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) |
10; 12; 13; 11; 15; 10 | — |
| PRIMARY Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) |
16; 15; 15; 14; 15 | — |
| PRIMARY Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels |
15; 6.6; 12; 21; 13 | — |
| PRIMARY Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry |
12; 9.5; 9.5; 10; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA 20 ng/mL
- Unable to read/speak English or Spanish
- Unwilling or unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT04890314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.