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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807492
• Other study ID #: 18D.644
• Status: Completed
• Start date: January 16, 2019
• Est. completion date: February 7, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: February 7, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.	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.	6 months

External Links

•   Thomas Jefferson University Hospital