Trial Outcomes & Findings for Improving Germline Testing in At-Risk Patients With Prostate Cancer (NCT NCT05470036)

Last Updated: 2026-01-16

Results Overview

Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Within 1 year

Results posted on

2026-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Video Intervention Group All patients were enrolled to the video intervention group.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Germline Testing in At-Risk Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Education Intervention Group n=50 Participants In-clinic educational session on germline testing in prostate cancer with a trained educator including video intervention.
Age, Continuous	68 years n=9 Participants
Sex: Female, Male Female	0 Participants n=9 Participants
Sex: Female, Male Male	50 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	39 Participants n=9 Participants
Race (NIH/OMB) More than one race	5 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=9 Participants
Family history No family history of cancer	15 Participants n=9 Participants
Family history Family history of cancer	35 Participants n=9 Participants

PRIMARY outcome

Timeframe: Within 1 year

Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.

Outcome measures

Outcome measures
Measure	Educational Intervention Group n=50 Participants In person educational intervention group
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.	41 Participants

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
Measure	Educational Intervention Group n=50 Participants In person educational intervention group
Patient Baseline Knowledge of Germline Testing	9.1 Units on a scale Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: Within 18 months

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

Outcome measures

Outcome measures
Measure	Educational Intervention Group n=50 Participants In person educational intervention group
Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing	9.2 Units on a scale Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: within 18 months

Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.

Outcome measures

Outcome measures
Measure	Educational Intervention Group n=50 Participants In person educational intervention group
Number of Participants With Pathogenic Germline Mutations	5 Participants

SECONDARY outcome

Timeframe: within 18 months

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

Outcome measures

Outcome measures
Measure	Educational Intervention Group n=50 Participants In person educational intervention group
Patient Knowledge of Germline Testing After the Educational Intervention.	9.2 units on a scale Interval 8.0 to 11.0

Adverse Events

Education Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rana McKay, MD

University of California, San Diego

Phone: (858) 822-5354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place