Social, Structural, and Lifestyle Drivers of Prostate Cancer Disparities

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.

Study Overview

Detailed Description

The investigators hypothesize that SSDH factors drive cancer development differentially by race, and including SSDH factors in prediction models can improve risk prediction to guide decision-making regarding screening, diagnosis, and treatment across race and ethnic groups.

PRIMARY OBJECTIVE:

To identify not yet discovered SSDH and lifestyle factors that associate with identification of unfavorable vs. favorable prostate cancer histology between Black, Hispanic, and Asian men.

OUTLINE:

UCSF participants who agreed to participate in the Urology 90991 Biobank Consent (UCSF internal review board (IRB) #11-05226), and urology surgeons at community hospitals may refer participants for radical prostatectomy to University of California, San Francisco. Potential participants will be approached by the UCSF study team for an offer to participate and Non-UCSF participants will be asked to sign a medical release form prior to the research team collecting data from your medical record about your prostate cancer and treatment.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mathew Cooperberg, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Participants will receive surveys to complete online via a secure system.
Other Names:
  • Surveys
Data will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics.
Other Names:
  • Medical Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of not yet identified factors contributing to prostate cancer
Time Frame: Up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Cooperberg, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

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