Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer

NCT07377006 | Not Yet Recruiting

• 2 other identifiers: 2025-1272NCI-2025-06571
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (3)

Group 1 (Qualitative interview)

OTHER

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

Other: Electronic Health Record Review; Other: Interview

Group 2 (Draft decision support tool, cognitive interview)

OTHER

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

Behavioral: Behavioral Intervention; Other: Interview

Group 3 (Decision tool)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Procedure: Biospecimen Collection; Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

View decision support tool

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Group 2 (Draft decision support tool, cognitive interview); Group 3 (Decision tool)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group 3 (Decision tool)

Electronic Health Record Review OTHER

Ancillary studies

Group 1 (Qualitative interview)

Genetic Counseling OTHER

Meet with genetic counselor

Group 3 (Decision tool)

Genetic Testing OTHER

Undergo standard of care genetic testing

Also known as: Genetic Analysis, Genetic Examination, Genetic Test

Group 3 (Decision tool)

Interview OTHER

Complete qualitative interview

Group 1 (Qualitative interview)

Survey Administration OTHER

Ancillary studies

Group 3 (Decision tool)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Behavior Therapy; Specimen Handling; Genetic Counseling; Genetic Testing; Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Genetic Techniques; Diagnostic Services; Preventive Health Services; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Debanjan Pain

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: January 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)