Recruiting

NCT Number: NCT06659614

Prostate Tissue BioBank

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.

Recruiting

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Key information

Conditions

Prostate Cancer Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Caitlin M Orr, PhD

CONTACT

215-615-3004

Kara N Maxwell, MD, PhD

CONTACT

215-898-9698

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):

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

Treatment and study plan

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 contacts

Contact information is provided by the study sponsor or research team.

Caitlin M Orr, PhD

CONTACT

215-615-3004

Kara N Maxwell, MD, PhD

CONTACT

215-898-9698

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Prostate Tissue Biobank for People at Genetic Risk for Aggressive Disease

Acronym: PTBB

Important dates

Study start: 2024
Primary completion: 2034
Study completion: 2034
First posted: Oct 26, 2024
Registry last updated: Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting