Prostate Tissue BioBank (PTBB)

November 4, 2025 updated by: Kara Maxwell, Abramson Cancer Center at Penn Medicine

Prostate Tissue Biobank for People at Genetic Risk for Aggressive Disease

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kara N Maxwell, MD, PhD
  • Phone Number: 215-898-9698

Study Contact Backup

  • Name: Caitlin M Orr, PhD
  • Phone Number: 215-615-3004

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Kara N Maxwell, MD, PhD
          • Phone Number: 215-898-9698
        • Contact:
          • Caitlin M Orr, PhD
          • Phone Number: 215-615-3004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Kara N Maxwell, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2034

Study Completion (Estimated)

January 1, 2034

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 21823
  • IRB 854327 (Other Identifier: University of Pennsylvania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study participant research data will be securely stored by the study investigators. Any plan to share this data will require a Data Use Agreement executed and approved by the University of Pennsylvania.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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