Prostate Tissue BioBank

NCT06659614 | Recruiting DMC

• 2 other identifiers: UPCC 21823IRB 854327
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Genetic Predisposition

Outcome Measures

Primary Outcomes (1)

• Clinical and pathological data for patients with prostate tissue samples

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

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People assigned male at birth, undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

You may qualify if:

• 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):
• \. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer

You may not qualify if:

• N/A

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collecting biospecimens including blood and tissue. DNA may be derived from either sample type. Tissue biospecimens will be collected from primary prostate biopsy via needle core biopsy, prostatectomy and metastatic soft tissue and bone biopsy.

MeSH Terms

Conditions

Prostatic Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kara N Maxwell, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara N Maxwell, MD, PhD

CONTACT

215-898-9698

Caitlin M Orr, PhD

CONTACT

215-615-3004

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)