Prostate CancerNCT07690579
Social, Structural, and Lifestyle Drivers of Prostate Cancer Disparities
An observational study of Prostate Cancer and Prostate Cancer Recurrent, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Metastases
- What is being tested?
- Questionnaires and Medical Record Review
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with prostate cancer with a planned RP scheduled to be performed at a University of California, San Francisco (UCSF) facility.
Who may be able to join
- Participants who have elected radical prostatectomy as prostate cancer treatment.
- Participants who have agreed to participate in the Urology Biobank.
Who cannot join
- Participant does not plan nor schedule a radical prostatectomy (RP) procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Kiana Washington, 415.514.8026, Kiana.Washington@ucsf.edu
Karina Acevedo, 415.353.7615, Karina.Acevedo@ucsf.edu
About this study
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.
Read the 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.
- Being tested
- Questionnaires, Medical Record Review
- Keywords
- Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Surveys
Participants will receive surveys to complete online via a secure system.
Medical Record ReviewOther
Also called Medical Chart Review
Data will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires; Other: Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start31 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew Cooperberg, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690579
- Sponsor's protocol ID
- 255517
- Other IDs
- U54CA302452
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with study collaborators during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social, Structural, and Lifestyle Drivers of Prostate Cancer Disparities
- ClinicalTrials.gov ID
- NCT07690579
- Acronym / sponsor ID
- 255517
- Keywords
- Radical Prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with prostate cancer | – | Other: Questionnaires, Other: Medical Record ReviewParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with prostate cancer with a planned RP scheduled to be performed at a University of California, San Francisco (UCSF) facility.
Key inclusion criteria (2 listed)
- Participants who have elected radical prostatectomy as prostate cancer treatment.
- Participants who have agreed to participate in the Urology Biobank.
Key exclusion criteria (1 listed)
- Participant does not plan nor schedule a radical prostatectomy (RP) procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants will receive surveys to complete online via a secure system. | Other | Men with prostate cancer |
| Medical Record ReviewAlso: Medical Chart ReviewData will be collected from participants medical charts which includes disease history, pathological findings, and other disease characteristics. | Other | Men with prostate cancer |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with study collaborators during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Cooperberg, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Cancer Recurrent, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiana Washington (415.514.8026, Kiana.Washington@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of not yet identified factors contributing to prostate cancer (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.