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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,953

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2021

Typical duration for all trials

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

May 13, 2021

Completed

2 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

May 6, 2025

Completed

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

May 13, 2021

Results QC Date

March 6, 2025

Last Update Submit

May 12, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (10)

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.
8 months
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.
12 months
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.
8 months, 12 months
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.
8 months, 12 months
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).
8 months, 12 months
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.
12 months
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.
8 months
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.
12 months
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.
8 months
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.
12 months