Prostate CarcinomaNCT07377006
Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer
A study testing Behavioral Intervention, Biospecimen Collection and Electronic Health Record Review in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. 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?
- Behavioral Intervention, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 31 Dec 2030
- 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
- 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
Who cannot join
- Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Debanjan Pain, 713-563-0020, DPain@mdanderson.org
Debanjan Pain
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Behavioral Intervention, Biospecimen Collection, Electronic Health Record Review, Genetic Counseling, Genetic Testing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
View decision support tool
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Electronic Health Record ReviewOther
Ancillary studies
Genetic CounselingOther
Meet with genetic counselor
Genetic TestingOther
Also called Genetic Analysis, Genetic Examination, Genetic Test
Undergo standard of care genetic testing
InterviewOther
Complete qualitative interview
InterviewOther
Complete cognitive interview
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Qualitative interview) | Other | Patients complete a qualitative interview that informs the development of the decision support tool. Receives: 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. Receives: 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. Receives: Behavioral: Behavioral Intervention; Procedure: Biospecimen Collection; Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 Feb 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 Dec 2030 (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 M.D. Anderson Cancer CenterThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debanjan Pain, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377006
- Sponsor's protocol ID
- 2025-1272
- Other IDs
- NCI-2025-06571, 2025-1272
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital
- ClinicalTrials.gov ID
- NCT07377006
- Acronym / sponsor ID
- 2025-1272
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jan 2026 (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 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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Qualitative interview) | Other | Other: Electronic Health Record Review, Other: InterviewPatients complete a qualitative interview that informs the development of the decision support tool. |
| Group 2 (Draft decision support tool, cognitive interview) | Other | Behavioral: Behavioral Intervention, Other: InterviewPatients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study. |
| Group 3 (Decision tool) | Experimental | Behavioral: Behavioral Intervention, Procedure: Biospecimen Collection, Other: Genetic Counseling, Other: Genetic Testing, Other: Survey AdministrationPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyView decision support tool | Behavioural | Group 2 (Draft decision support tool, cognitive interview), Group 3 (Decision tool) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group 3 (Decision tool) |
| Electronic Health Record ReviewAncillary studies | Other | Group 1 (Qualitative interview) |
| Genetic CounselingMeet with genetic counselor | Other | Group 3 (Decision tool) |
| Genetic TestingAlso: Genetic Analysis, Genetic Examination, Genetic TestUndergo standard of care genetic testing | Other | Group 3 (Decision tool) |
| InterviewComplete qualitative interview | Other | Group 1 (Qualitative interview) |
| InterviewComplete cognitive interview | Other | Group 2 (Draft decision support tool, cognitive interview) |
| Survey AdministrationAncillary studies | Other | Group 3 (Decision tool) |
Primary outcome
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
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 25 Sep 2026.
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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.
Debanjan Pain principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Biospecimen Collection and Electronic Health Record Review in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 4 inclusion and 1 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 25 Sep 2026.