Improving Germline Testing in At-Risk Patients With Prostate Cancer (IMPRINT)

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Educational intervention.

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University Of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Educational intervention; In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.	Behavioral: Educational intervention.; Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.	Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.	Within 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Baseline Knowledge of Germline Testing	Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge	Baseline
Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing	Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge	Within 18 months
Number of Participants With Pathogenic Germline Mutations	Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.	within 18 months
Patient Knowledge of Germline Testing After the Educational Intervention.	Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge	within 18 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Rana McKay, MD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prostate cancer; Education; Video; Germline testing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Early Intervention, Educational
• Other Study ID Numbers: 20-0551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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