Recruiting

BioBank

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06659614

Conditions

Prostate Cancer

Genetic Predisposition

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06659614

Start date

Jan 1, 2024

Status verified date

Nov, 2025

Completion date

Jan, 2034

Anticipated

Primary completion date

Jan, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Clinical and pathological data for patients with prostate tissue samples [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kara N Maxwell, MD, PhD

215-898-9698

Caitlin M Orr, PhD

215-615-3004

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kara N Maxwell, MD, PhD

215-898-9698

Caitlin M Orr, PhD

215-615-3004

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-11-05.