Prostate CancerPTBBNCT06659614
Prostate Tissue BioBank
An observational study of Prostate Cancer and Genetic Predisposition, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Genetic Predisposition
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Jan 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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):
- 1. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kara N Maxwell, MD, PhD contact
Caitlin M Orr, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kara N Maxwell, MD, PhD, 215-898-9698
Caitlin M Orr, PhD, 215-615-3004
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Genetic Predisposition
- Medical subject headings
- Prostatic Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jan 2024
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Maxwell, Abramson Cancer Center at Penn Medicine
- Investigators
- Kara N Maxwell, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659614
- Sponsor's protocol ID
- UPCC 21823
- Other IDs
- IRB 854327
- Acronym
- PTBB
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Tissue Biobank for People at Genetic Risk for Aggressive Disease
- ClinicalTrials.gov ID
- NCT06659614
- Acronym / sponsor ID
- PTBB / UPCC 21823
- Conditions
- Prostate Cancer, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- 1. Patients undergoing prostate biopsies as a part of their prostate cancer screening OR biopsy or prostatectomy due to a diagnosis of prostate cancer
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara N Maxwell, MD, PhD contact
Caitlin M Orr, PhD contact
Kara N Maxwell, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Genetic Predisposition, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara N Maxwell, MD, PhD (215-898-9698), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and pathological data for patients with prostate tissue samples (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.