Prostate Cancer Genetic Risk Evaluation and Screening Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05129605
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
35 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Prostate cancer screening — DIAGNOSTIC_TEST
    Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Study Details

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.

Key Dates

Start date
Feb 12, 2020
Status verified
Oct 2024
Primary completion
Dec 31, 2030
Completion
Dec 31, 2040

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Cohort A
    Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
  • Arm: Cohort B
    Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes
  • Arm: Cohort C
    Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Primary Outcome Measure

Diagnosis of prostate cancer [ Time Frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Massachusetts General Hospital· Boston, MA

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