Prostate Tissue BioBank

NCT ID: NCT06659614

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2034-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Genetic Predisposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kara Maxwell

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kara N Maxwell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kara N Maxwell, MD, PhD

Role: CONTACT

215-898-9698

Caitlin M Orr, PhD

Role: CONTACT

215-615-3004

Facility Contacts

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Kara N Maxwell, MD, PhD

Role: primary

215-898-9698

Caitlin M Orr, PhD

Role: backup

215-615-3004

Other Identifiers

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IRB 854327

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 21823

Identifier Type: -

Identifier Source: org_study_id

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