Precision-Based Genomics in Prostate Cancer
A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer
- Prostate Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- National Cancer Institute (NCI)
- Enrolment target
- 2,000
- Started
- 14 September 2021
- Main results due
- 30 June 2029
- Study sites
- 11
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 120 years.
- Men only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
* INCLUSION CRITERIA: * Subjects with histologically confirmed prostate cancer. * Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high(\[defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB \[greater than or equal to 16 mut/Mb\]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified) OR * be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration * Age greater than or equal to 18 years old. * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -None
What this study is about
In the sponsor’s own words, from the registry.
Background:
Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is.
Objective:
To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment.
Eligibility:
Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study and/or have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time.
Design:
Participants will be screened with a review of their medical records. Their gene test results will be reviewed, if available. They will be asked questions over the phone or in person.
Participants do not need to visit the NIH for this study. But if they visit NIH for another study, their data and test results will be collected. They may give blood and urine samples. They may give leftover tumor samples. These samples will be used to study their genes.
Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail. They will be asked questions about their health. Data from their medical records will be collected.
Participants will have testosterone and prostate-specific antigen (PSA) tests.
Participants may be invited to NIH to give blood samples for research.
Participants on this study will be followed for life.
Study sites(11)
University of California San Diego
La Jolla, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Recruiting
NorthShore University HealthSystem
Evanston, Illinois, United States
Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting
Dana Farber Cancer Institute, Boston, MA
Boston, Massachusetts, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Mount Sinai Hospital
New York, New York, United States
Not yet recruiting
Weill Cornell Medicine
New York, New York, United States
Not yet recruiting
Oregon Health Sciences University
Portland, Oregon, United States
Not yet recruiting
University of Washington
Seattle, Washington, United States
Recruiting
Showing 11 of 11 sites. 7 of the 11 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04706663. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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