Improving Germline Testing in At-Risk Patients With Prostate Cancer

Prostate Cancer Clinical Trial

— IMPRINT  

Official title:

IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470036
• Other study ID #: 20-0551
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Rana McKay, MD
• Phone: 8588226185
• Email: rmckay[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Educational intervention.
Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.	Accrual rate from study activation	1 year
Primary	Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.	Rate of patients agreeing to proceed with germline testing among those approached with the educational intervention.	1 year
Secondary	Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention.	Assessment via baseline and post intervention knowledge questionnaire.	18 months
Secondary	Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing	Assessment via baseline and post intervention questionnaire.	18 months
Secondary	Impact of germline testing results on prostate cancer management	Assessment via clinician survey upon receipt of germline testing results.	18 months
Secondary	Prevalence of pathogenic germline mutations in patient population	Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.	18 months