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NCT Number: NCT07377006

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location contact

Debanjan Pain

CONTACT

[email protected]

713-563-0020

Debanjan Pain

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer.

II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community.

III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas.

SECONDARY OBJECTIVES:

I. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas.

II. Assess the change in completion of germline genetic testing with utilization of the decision support tool.

OUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial.

GROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool.

GROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.

GROUP 3: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

View decision support tool

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Electronic Health Record Review

Other

Ancillary studies

Genetic Counseling

Other

Meet with genetic counselor

Genetic Testing

Other

Undergo standard of care genetic testing

Other names: Genetic Analysis, Genetic Examination, Genetic Test

interview

Other

Complete qualitative interview

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year

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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 29, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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