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

NCT ID: NCT03807492

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-16

Study Completion Date

2024-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JT 13180

Identifier Type: OTHER

Identifier Source: secondary_id

18D.644

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prostate Cancer Prospective Cohort
NCT00937586 ACTIVE_NOT_RECRUITING