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Clinical Trials/NCT06659614
NCT06659614
Recruiting
Not Applicable

Prostate Tissue Biobank for People at Genetic Risk for Aggressive Disease

Abramson Cancer Center at Penn Medicine1 site in 1 country200 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
200
Locations
1
Primary Endpoint
Clinical and pathological data for patients with prostate tissue samples
Status
Recruiting
Last Updated
5 months ago

Overview

Brief 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. The investigators 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
January 1, 2034
Last Updated
5 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kara Maxwell

Principal investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

Inclusion Criteria

  • Carriers (Group 1):
  • Confirmed pathogenic or likely pathogenic variant in a known prostate cancer risk gene.
  • 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

  • Not provided

Outcomes

Primary Outcomes

Clinical and pathological data for patients with prostate tissue samples

Time Frame: 5 years

Data will be collected on consented patients who undergo prostate biopsy, prostatectomy or metastatic biopsy.

Study Sites (1)

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