NCT03076242

Brief Summary

This is a prospective research registry and prospective genetic testing cohort study. The goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

March 6, 2017

Last Update Submit

April 28, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

  • Family cancer history collection

    Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility.

    Three years

  • Behavioral measure collection

    Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process

    Three years

  • Biospecimen bank

    Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk

    Three years

  • Genetic and genomic sequencing

    Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk

    Three years

  • Participant follow-up

    Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

    Three years

Study Arms (1)

Gem Registry

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

Other: GEM Registry

Interventions

GEM RegistryOTHER

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

Gem Registry

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer

You may qualify if:

  • Men with a personal history of prostate cancer
  • Unaffected males who are at higher risk for prostate cancer

You may not qualify if:

  • Age \< 18 years
  • Mental or cognitive impairment that interferes with ability to provide informed consent
  • Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Giri Veda, M.D.

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 10, 2017

Study Start

October 23, 2014

Primary Completion

January 15, 2019

Study Completion

May 16, 2019

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

US(3)