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: Recruiting
• 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 (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana McKay, MD; Phone Number: 8588226185; Email: rmckay@ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Rana R McKay, MD; Phone Number: 858-822-6185; Email: rmckay@health.ucsd.edu

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
Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.	Accrual rate from study activation	1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Impact of germline testing results on prostate cancer management	Assessment via clinician survey upon receipt of germline testing results.	18 months
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

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 (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

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 (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; Education; Video; Germline testing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• 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