Prostate CarcinomaNCT04763980
Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer
A study testing Educational Intervention, Genetic Testing and Survey Administration in people with Prostate Carcinoma, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Educational Intervention, Genetic Testing and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2021to 31 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:
- Participants:
- Age >=18 years old.
- Able to speak and read in English.
- Have no known cancer risk genetic mutation.
- Self-identify as Black or African American.
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- Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines.
- ENROLLING: PART 1:
- Participants:
- Age >=18 years old.
- Able to speak and read in English.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to verbally consent.
- Self-identifies as Black or African-American.
- Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer.
- Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback.
- Providers:
- Self-identifies as a medical oncologist or genetics provider.
- Able to speak and read in English.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to verbally consent.
- ENROLLING: PART 2:
- Participants:
- Age >=18 years old.
- Able to speak and read in English.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to provide written informed consent.
- Have no known cancer risk genetic mutation.
- Self-identify as Black or African American.
- Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines.
- For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.
Who cannot join
- CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
- Prior germline genetic test.
- Age <18 years old.
- Unable to read or answer forms.
- ENROLLING: PART 1:
- 1. Contraindication to any study-related procedure or assessment.
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- ENROLLING: PART 2:
- Self-reports prior germline genetic test.
- Contraindication to any study-related procedure or assessment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Miriam Perales, Miriam.Perales@ucsf.edu
- Not yet recruiting
San Francisco Veterans Administration Medical Center
San Francisco, California, 94121
- Recruiting
University of California San Francisco
San Francisco, California, 94143
UCSF Genitourinary Medical Oncology Recruitment, 877-827-3222, GUTrials@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts).
II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2).
SECONDARY OBJECTIVES:
- To assess decisional conflict among African American men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach (Initial Pilot Cohorts).
II. To assess facilitators to the intervention (Part 1).
III. To assess acceptability of the intervention (Parts 1 and 2).
IV. To characterize patient and health coach use of ProGene (Part 1).
- To evaluate completion rate of germline testing among participants receiving the intervention (Part 2).
VI. To evaluate change in participant knowledge about germline testing among patient participants (Part 2).
VII. To evaluate change in participant attitudes toward germline testing among patient participants (Part 2).
VIII. To evaluate change in decisional conflict about germline testing among patient participants (Part 2).
IX. To evaluate reach of the intervention (Part 2).
- To evaluate barriers and facilitators to the intervention (Part 2).
XI. To identify reasons for declining germline testing.
TERTIARY OBJECTIVE:
- To assess the germline mutation rate among African American men with prostate cancer (Initial Pilot Cohorts)
OUTLINE: The initial pilot phase of the study has concluded. Participants are assigned to Parts 1 or 2 of current study.
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A:
Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing.
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT B:
Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
PART 1:
Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
PART 2:
Participants in this secondary pilot engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
- Conditions
- Prostate Carcinoma
- Being tested
- Educational Intervention, Genetic Testing, Survey Administration, ProGene Artificial Intelligence (AI) Platform, Interviews
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in educational session with health coach
Genetic TestingOther
Also called Genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Survey AdministrationOther
Also called Questionnaire Administration
Complete surveys throughout course of study.
ProGene Artificial Intelligence (AI) PlatformOther
Also called ProGene AI Platform, ProGene
AI Platform to be used by health coach during sessions
InterviewsOther
Also called Participant interviews
Participant and provider interviews will be conducted by study staff.
| Study group | Role | What they receive |
|---|---|---|
| CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing) | Active comparator | Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing. Receives: Other: Genetic Testing; Other: Survey Administration |
| CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing) | Experimental | Participants engage in educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing. Participant and provider interviews will be conducted at end of study. Receives: Other: Educational Intervention; Other: Genetic Testing; Other: Survey Administration |
| Part 1 (educational session, survey, genetic testing) | Experimental | Participants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing. Receives: Other: Educational Intervention; Other: Genetic Testing; Other: Survey Administration; Other: ProGene Artificial Intelligence (AI) Platform; Other: Interviews |
| Part 2 Pilot (educational session, survey, genetic testing) | Experimental | Clinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing. Receives: Other: Educational Intervention; Other: Genetic Testing; Other: Survey Administration; Other: ProGene Artificial Intelligence (AI) Platform; Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate for germline testing (Initial Pilot Cohort and Part 2)
The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.
Measured: At baseline (1 day)
Frequency of reported barriers to interventions (Part 1)
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Measured: Up to 30 days
Secondary outcomes (11)
Decisional conflict scale score (Initial Pilot Cohort and Part 2)
The decisional conflict scale will be scored using a validated instrument. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Summary statistics with median and interquartile range will be obtained.
Measured: Up to 120 days
Frequency of reported facilitators to interventions (Part 1 and 2)
Participant- and provider-reported facilitators to engaging in the intervention for participants to make an informed decision about germline testing.
Measured: Up to 120 days
Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)
Participant-reported acceptability of the intervention will be described using the TFA questionnaire. Scores on the TFA items will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. All negatively worded items will be reverse-scored for a total score of 24-120. Higher scores represent greater acceptability (more positive attitudes). The mean score and standard deviation will be reported.
Measured: Up to 120 days
Number of recorded inputs into ProGene (Part 1)
The number of recorded data inputs into the ProGene platform will be reported descriptively to characterize patient-participant and health coach use of ProGene.
Measured: Up to 30 days
Proportion of patient participants who complete germline testing (Part 2)
The completion rate is defined as the proportion of patient-participants who complete germline testing within 90 days of intervention will be reported.
Measured: Up to 120 days
Mean score of adapted KnowGene germline testing knowledge survey (Part 2)
Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al.+ select questions from a survey from Rogith, et al. will be utilized to measure the level of cancer genomic testing knowledge. "Don't know" will be scored as incorrect. The proportion of correct responses will be calculated to generate a total score between 0-100, with a higher score indicating greater knowledge. No items will be weighted. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.
Measured: Up to 120 days
Mean score of genetic testing attitudes survey (Part 2)
Attitude and expectations measure for tumor genetic testing is a 17-item measure adapted from a validated survey from Blanchette, et al. including one open-ended investigator-created item. Items on the attitude scoring scale range from "Yes" = 1 and "No" or "Unsure" = 0
Measured: Up to 120 days
Proportion of individuals classified as "supporters" (Part 2)
Proportion of individuals classified as "supporters" of genetic testing
Measured: Up to 120 days
Proportion of participants who consent to study (Part 2)
Proportion of participants who consent to study among those approached as potential participants will be reported
Measured: Up to 120 days
Frequency of reported barriers to interventions (Part 2)
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Measured: Up to 120 days
Frequency of reasons for declining testing (Part 2)
Patient-participant reported reasons for declining germline testing will be reported descriptively.
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Jan 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Lazarex Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel Kwon, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763980
- Sponsor's protocol ID
- 20553
- Other IDs
- NCI-2021-01027
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2021
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04763980
- Acronym / sponsor ID
- 20553
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Lazarex Cancer Foundation
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Feb 2021 (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.
This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.
Detailed description
PRIMARY OBJECTIVES:
- To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts).
II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2).
SECONDARY OBJECTIVES:
- To assess decisional conflict among African American men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach (Initial Pilot Cohorts).
II. To assess facilitators to the intervention (Part 1).
III. To assess acceptability of the intervention (Parts 1 and 2).
IV. To characterize patient and health coach use of ProGene (Part 1).
- To evaluate completion rate of germline testing among participants receiving the intervention (Part 2).
VI. To evaluate change in participant knowledge about germline testing among patient participants (Part 2).
VII. To evaluate change in participant attitudes toward germline testing among patient participants (Part 2).
VIII. To evaluate change in decisional conflict about germline testing among patient participants (Part 2).
IX. To evaluate reach of the intervention (Part 2).
- To evaluate barriers and facilitators to the intervention (Part 2).
XI. To identify reasons for declining germline testing.
TERTIARY OBJECTIVE:
- To assess the germline mutation rate among African American men with prostate cancer (Initial Pilot Cohorts)
OUTLINE: The initial pilot phase of the study has concluded. Participants are assigned to Parts 1 or 2 of current study.
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A:
Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing.
CLOSED TO ENROLLMENT: INITIAL PILOT COHORT B:
Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
PART 1:
Participants engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
PART 2:
Participants in this secondary pilot engage in an educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing) | Active comparator | Other: Genetic Testing, Other: Survey AdministrationParticipants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing. |
| CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing) | Experimental | Other: Educational Intervention, Other: Genetic Testing, Other: Survey AdministrationParticipants engage in educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing. Participant and provider interviews will be conducted at end of study. |
| Part 1 (educational session, survey, genetic testing) | Experimental | Other: Educational Intervention, Other: Genetic Testing, Other: Survey Administration, Other: ProGene Artificial Intelligence (AI) Platform, Other: InterviewsParticipants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing. |
| Part 2 Pilot (educational session, survey, genetic testing) | Experimental | Other: Educational Intervention, Other: Genetic Testing, Other: Survey Administration, Other: ProGene Artificial Intelligence (AI) Platform, Other: InterviewsClinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Age >=18 years old.
- Able to speak and read in English.
- Have no known cancer risk genetic mutation.
- Self-identify as Black or African American.
- Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines.
Key exclusion criteria (9 listed)
- CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
- Prior germline genetic test.
- Age <18 years old.
- Unable to read or answer forms.
- 1. Contraindication to any study-related procedure or assessment.
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalParticipate in educational session with health coach | Other | CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing), Part 1 (educational session, survey, genetic testing), Part 2 Pilot (educational session, survey, genetic testing) |
| Genetic TestingAlso: Genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing), CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing), Part 1 (educational session, survey, genetic testing), Part 2 Pilot (educational session, survey, genetic testing) |
| Survey AdministrationAlso: Questionnaire AdministrationComplete surveys throughout course of study. | Other | CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing), CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing), Part 1 (educational session, survey, genetic testing), Part 2 Pilot (educational session, survey, genetic testing) |
| ProGene Artificial Intelligence (AI) PlatformAlso: ProGene AI Platform, ProGeneAI Platform to be used by health coach during sessions | Other | Part 1 (educational session, survey, genetic testing), Part 2 Pilot (educational session, survey, genetic testing) |
| InterviewsAlso: Participant interviewsParticipant and provider interviews will be conducted by study staff. | Other | Part 1 (educational session, survey, genetic testing), Part 2 Pilot (educational session, survey, genetic testing) |
Primary outcome
Consent rate for germline testing (Initial Pilot Cohort and Part 2)
Time frame: At baseline (1 day)
The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.
Frequency of reported barriers to interventions (Part 1)
Time frame: Up to 30 days
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
11 secondary outcomes
Decisional conflict scale score (Initial Pilot Cohort and Part 2)
Time frame: Up to 120 days
Frequency of reported facilitators to interventions (Part 1 and 2)
Time frame: Up to 120 days
Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)
Time frame: Up to 120 days
Number of recorded inputs into ProGene (Part 1)
Time frame: Up to 30 days
Proportion of patient participants who complete germline testing (Part 2)
Time frame: Up to 120 days
Mean score of adapted KnowGene germline testing knowledge survey (Part 2)
Time frame: Up to 120 days
Mean score of genetic testing attitudes survey (Part 2)
Time frame: Up to 120 days
Proportion of individuals classified as "supporters" (Part 2)
Time frame: Up to 120 days
Proportion of participants who consent to study (Part 2)
Time frame: Up to 120 days
Frequency of reported barriers to interventions (Part 2)
Time frame: Up to 120 days
Frequency of reasons for declining testing (Part 2)
Time frame: Up to 120 days
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 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Daniel Kwon, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Genetic Testing and Survey Administration in people with Prostate Carcinoma, run by University of California, San Francisco at 3 sites 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 31 inclusion and 9 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 UCSF Genitourinary Medical Oncology Recruitment (877-827-3222, GUTrials@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate for germline testing (Initial Pilot Cohort and Part 2) (time frame: At baseline (1 day)). The study lists 2 primary outcomes in all. 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 31 Dec 2025.