NCT07690579

Brief Summary

Prostate Cancer (PC) is the most common non-cutaneous malignancy diagnosed and second leading cause of cancer death among men across the United States. PC among Black men accounts for a higher proportion alike of cancer diagnoses and deaths. In the prostate specific antigen (PSA)-based screening era, mortality rates improved at a similar velocity among Black and White men, but the 2- to 3-fold excess mortality burden borne by Black men has persisted over the past 40 years, the second highest among all major cancers. In recent years mortality is rising among Black men, and at a rapid velocity. The explanations for this disparity-the extent to which it is attributable to genetics, environmental factors including Structural and Social Determinants of Health (SSDH), or access to care-are multifactorial and have been elucidated to a limited extent. A large meta-analysis recently found that across dozens of studies and cohorts, greater adjustment for clinical and SSDH factors generally resulted in race itself dropping as a significant predictor. These and other findings suggest that the determinants of disparity be identified at time of, and prior to, cancer diagnosis, and that both genetic and environmental factors contribute to earlier development and progression.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress17%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Identification of not yet identified factors contributing to prostate cancer

    Genomic and SSDH factors will be evaluated to locate not yet identified factors that are associated with greater immune activation and prediction of unfavorable vs. favorable prostate cancer biology by race and ethnicity groups.

    Up to 2 years

Study Arms (1)

Men with prostate cancer

Participants who have planned or completed a non-investigational radical prostatectomy will be asked to complete a series of questionnaires online covering a subset of community-informed SSDH measures and individual exposures. Responses will be recorded in a secured database. . It will take about up to 2 hours to complete the surveys. There will be questions about your demographics (education level, income, employment, etc.); health care access and quality; lifestyle and behaviors. Data from your medical record about your prostate cancer and treatment will also be collected.

Other: QuestionnairesOther: Medical Record Review

Interventions

Participants will receive surveys to complete online via a secure system.

Also known as: Surveys
Men with prostate cancer

Data will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics.

Also known as: Medical Chart Review
Men with prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with prostate cancer with a planned RP scheduled to be performed at a University of California, San Francisco (UCSF) facility.

You may qualify if:

  • Participants who have elected radical prostatectomy as prostate cancer treatment.
  • Participants who have agreed to participate in the Urology Biobank.

You may not qualify if:

  • Participant does not plan nor schedule a radical prostatectomy (RP) procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Matthew Cooperberg, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified data may be shared with study collaborators during the course of the study.

Shared Documents
STUDY PROTOCOL, SAP

Locations