Recruiting

Germline Genetic Testing

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07377006

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Intervention

Biospecimen Collection

Electronic Health Record Review

Genetic Counseling

Genetic Testing

Study Details

Brief summary:

This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.

Conditions

Prostate Carcinoma

Study ID

NCT07377006

Start date

Feb 2, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital
  • Were recommended for germline genetic testing by their oncology provider
  • Can provide informed consent
  • Can communicate in English or Spanish

Exclusion Criteria:

  • Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition

Study Design

Enrollment

108 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Group 1 (Qualitative interview)

Patients complete a qualitative interview that informs the development of the decision support tool.

other: Group 2 (Draft decision support tool, cognitive interview)

Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.

experimental: Group 3 (Decision tool)

Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.

Interventions

Behavioral Intervention

View decision support tool

Biospecimen Collection

Undergo blood sample collection

Electronic Health Record Review

Ancillary studies

Genetic Counseling

Meet with genetic counselor

Genetic Testing

Undergo standard of care genetic testing

Interview

Complete qualitative interview

Interview

Complete cognitive interview

Survey Administration

Ancillary studies

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Debanjan Pain

713-563-0020DPain@mdanderson.org

Principal Investigator:

Debanjan Pain

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.