RECRUITING

Prostate Cancer Genetic Risk Evaluation and Screening Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Official Title

Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Quick Facts

Study Start:2020-02-12
Study Completion:2040-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05129605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 74 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men 35-74 years old
  2. * No known diagnosis of prostate cancer
  3. * Life expectancy \>10 years
  4. * Meet cohort A, B, or C criteria
  5. * Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
  6. * Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
  7. * Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
  1. * Prior diagnosis or treatment of prostate cancer
  2. * Inability to undergo prostate MRI
  3. * Inability to receive MRI contrast agent

Contacts and Locations

Study Contact

Olympia Price
CONTACT
857-238-3838
oprice@partners.org

Principal Investigator

Keyan Salari, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Keyan Salari, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-12
Study Completion Date2040-12

Study Record Updates

Study Start Date2020-02-12
Study Completion Date2040-12

Terms related to this study

Keywords Provided by Researchers

  • BRCA2
  • BRCA1
  • Mismatch Repair Deficiency
  • Lynch Syndrome
  • HOXB13
  • Family History of Prostate Cancer

Additional Relevant MeSH Terms

  • Prostatic Neoplasm
  • Prostate Cancer
  • BRCA2 Mutation
  • BRCA1 Mutation
  • ATM Gene Mutation
  • MMR Mutation
  • Lynch Syndrome
  • Genetic Predisposition to Disease