Improving Germline Testing in At-Risk Patients With Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Educational intervention.

• Registration Number: NCT05470036
• Lead Sponsor: University of California, San Diego

Brief Summary

A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

Detailed Description

This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.

Study Timeline

• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Study Start: 2022-09-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. Men, age greater than or equal to 18 years of age.
2. Diagnosis of prostate cancer of any histology.
3. Must meet NCCN guidelines for germline testing

Exclusion Criteria

1. Have had prior germline testing.
2. Have somatic genetic testing that is positive for a possible germline variant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Educational intervention	Educational intervention.	In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.

Primary Outcome Measures

Name	Time	Method
Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.	1 year	Rate of patients agreeing to proceed with germline testing among those approached with the educational intervention.
Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.	1 year	Accrual rate from study activation

Secondary Outcome Measures

Name	Time	Method
Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing	18 months	Assessment via baseline and post intervention questionnaire.
Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention.	18 months	Assessment via baseline and post intervention knowledge questionnaire.
Impact of germline testing results on prostate cancer management	18 months	Assessment via clinician survey upon receipt of germline testing results.
Prevalence of pathogenic germline mutations in patient population	18 months	Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States