Prostate Tissue Biobank for People at Genetic Risk for Aggressive Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Clinical and pathological data for patients with prostate tissue samples
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kara Maxwell
Principal investigator
Abramson Cancer Center at Penn Medicine