NCT05470036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

July 17, 2022

Results QC Date

November 8, 2025

Last Update Submit

December 27, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerGermline testingEducationVideo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient Baseline Knowledge of Germline Testing

    Baseline

  • Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing

    Within 18 months

  • Number of Participants With Pathogenic Germline Mutations

    within 18 months

  • Patient Knowledge of Germline Testing After the Educational Intervention.

    within 18 months

Study Arms (1)

Educational intervention

OTHER

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

Behavioral: Educational intervention.

Interventions

Educational intervention.BEHAVIORAL

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

Educational intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have had prior germline testing.
  • Have somatic genetic testing that is positive for a possible germline variant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Results Point of Contact

Title
Rana McKay, MD
Organization
University of California, San Diego
CancerCTO@health.ucsd.edu
(858) 822-5354

Study Officials

  • Rana McKay, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Urology

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 22, 2022

Study Start

September 27, 2022

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

January 16, 2026

Results First Posted

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)