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

February 17, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Debanjan Pain
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1 (Qualitative interview)
Patients complete a qualitative interview that informs the development of the decision support tool.
Other: Electronic Health Record Review
Ancillary studies
Other: Interview
Complete cognitive interview
Other: Interview
Complete qualitative interview
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.
Other: Interview
Complete cognitive interview
Other: Interview
Complete qualitative interview
Behavioral: Behavioral Intervention
View decision support tool
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
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.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Survey Administration
Ancillary studies
Behavioral: Behavioral Intervention
View decision support tool
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioral
Other: Genetic Counseling
Meet with genetic counselor
Other: Genetic Testing
Undergo standard of care genetic testing
Other Names:
  • Genetic Examination
  • Genetic Test
  • Genetic Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Debanjan Pain, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 15, 2025

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1272 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2025-06571 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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