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Status:

RECRUITING

Precision-Based Genomics in Prostate Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Brief Summary

Background: Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s...

Detailed Description

Background: * Prostate cancer is the most common cancer and the second leading cause of death in males in the United States with an estimated 191,930 new cases and 33,330 deaths in 2020. * There has ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Subjects with histologically confirmed prostate cancer.
  • Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high(\[defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB \[greater than or equal to 16 mut/Mb\]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified)
  • OR
  • be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration
  • Age greater than or equal to 18 years old.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • EXCLUSION CRITERIA:
  • None

Exclusion

    Key Trial Info

    Start Date :

    September 14 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2027

    Estimated Enrollment :

    2000 Patients enrolled

    Trial Details

    Trial ID

    NCT04706663

    Start Date

    September 14 2021

    End Date

    June 30 2027

    Last Update

    January 9 2026

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    University of California San Diego

    La Jolla, California, United States, 92093

    2

    University of California San Francisco

    San Francisco, California, United States, 94143

    3

    NorthShore University HealthSystem

    Evanston, Illinois, United States, 60201

    4

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892