Prostate Tissue BioBank

Clinicaltrials.gov ID: NCT06659614
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 200

Conditions

Prostate Cancer, Genetic Predisposition

Summary

Prostate cancer is also the most common cancer in men with inherited pathogenic variants in BRCA1 and BRCA2. Beyond BRCA1/2, other genes are known to increase the risk of prostate cancer, including ATM, TP53 and HOXB13. We have shown that 5% of men diagnosed with prostate cancer localized to their prostate gland and up to 10-15% of patients with metastatic prostate cancer gland are carriers of an inherited gene mutation.The Prostate Tissue BioBank is a prospective study which aims to create a biorepository of prostate tissue samples from prostate biopsies and prostatectomies and matched germline DNA from pathogenic mutation carriers in addition to age-matched control samples. Our primary goal is to investigate prostate cancer development and treatment response in carriers of germline DNA repair mutations, as compared to non-carrier controls.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Kara N Maxwell, MD, PhD
  • 215-898-9698

Principal Investigator

  • Kara N Maxwell, MD, PhD

Eligibility Criteria

Inclusion Criteria:

Carriers (Group 1):

1. Confirmed pathogenic or likely pathogenic variant in a known prostate cancer risk gene.
2. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Controls (Group 2):

1. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

Exclusion Criteria:

* N/A

Study Plan

Carriers

Eligible subjects will have confirmed pathogenic or likely pathogenic variants in a prostate cancer risk gene, and will also be undergoing prostate needle biopsy, prostatectomy or metastatic biopsy. Study participation will request access to medical information, blood and tissue samples.

Controls

Eligible subjects will be undergoing prostate needle biopsy, prostatectomy or metastatic biopsy. Study participation will request access to medical information, blood and tissue samples.

Outcome Measures

Primary Outcome Measures

Clinical and pathological data for patients with prostate tissue samples

Time Frame: 5 years

Timeline

  • Last Updated
    October 26, 2024
  • Start Date
    October 26, 2024
  • Today
    May 12, 2025
  • Completion Date ( Estimated )
    January 1, 2034

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