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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational intervention.
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate cancer, Germline testing, Education, Video

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Educational intervention

Arm Description

In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Impact of germline testing results on prostate cancer management
Assessment via clinician survey upon receipt of germline testing results.
Prevalence of pathogenic germline mutations in patient population
Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.

Full Information

First Posted
July 17, 2022
Last Updated
November 2, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05470036
Brief Title
Improving Germline Testing in At-Risk Patients With Prostate Cancer
Acronym
IMPRINT
Official Title
IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Germline testing, Education, Video

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Other
Arm Description
In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention.
Intervention Description
Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.
Primary Outcome Measure Information:
Title
Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.
Description
Accrual rate from study activation
Time Frame
1 year
Title
Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
Description
Rate of patients agreeing to proceed with germline testing among those approached with the educational intervention.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention.
Description
Assessment via baseline and post intervention knowledge questionnaire.
Time Frame
18 months
Title
Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing
Description
Assessment via baseline and post intervention questionnaire.
Time Frame
18 months
Title
Impact of germline testing results on prostate cancer management
Description
Assessment via clinician survey upon receipt of germline testing results.
Time Frame
18 months
Title
Prevalence of pathogenic germline mutations in patient population
Description
Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.
Time Frame
18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men, age greater than or equal to 18 years of age. Diagnosis of prostate cancer of any histology. Must meet NCCN guidelines for germline testing Exclusion Criteria: Have had prior germline testing. Have somatic genetic testing that is positive for a possible germline variant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana McKay, MD
Phone
8588226185
Email
rmckay@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana McKay, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana R McKay, MD
Phone
858-822-6185
Email
rmckay@health.ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Germline Testing in At-Risk Patients With Prostate Cancer

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