Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03807492
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-01-14
• Study Start: 2019-01-16
• Study First Posted: 2019-01-17
• Primary Completion: 2022-06-01
• Study Completion: 2024-02-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 241

Inclusion Criteria

• Men with a personal history of prostate cancer
• Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)
• Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7
• Men with a known familial mutation
• Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -

Exclusion Criteria

• Age < 18 years
• Mental or cognitive impairment that interferes with ability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.	6 months	Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States