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

NCT03807492 | Completed

• 2 other identifiers: 18D.644JT 13180
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EMPOWeR Study

This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As this is a study on prostate cancer, women and children are not included. Minorities meeting eligibility criteria may participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any male \>18 years with prostate cancer is eligible. Furthermore, unaffected men at higher risk for prostate cancer (family history of prostate cancer or African American males) are also eligible for the study. Men will be approached by their providers or study staff during their clinical appointments for participation. Emails or mailings may also be sent to introduce the study to patients and to contact us for participation. Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR.

You may qualify if:

• 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 -

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 17, 2019
• Study Start: January 16, 2019
• Primary Completion: June 1, 2022
• Study Completion: February 7, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)