Improving Germline Testing in At-Risk Patients With Prostate Cancer

NCT ID: NCT05470036

Last Updated: 2026-01-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educational intervention

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

Group Type OTHER

Educational intervention.

Intervention Type BEHAVIORAL

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

Interventions

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Educational intervention.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Rana Mckay

Associate Professor of Medicine and Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rana McKay, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-0551

Identifier Type: -

Identifier Source: org_study_id

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