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NCT04706663Recruiting

Precision-Based Genomics in Prostate Cancer

A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
12 Jan 2021
Start date
Sept 2021
Primary completion date
Jun 2029
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT04706663

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From Sept 2021 to the primary completion date, Jun 2029
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • -None

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to 120 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesNot yet recruiting
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
Dana Farber Cancer Institute, Boston, MA
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
NorthShore University HealthSystem
Coordinator of this site? Confirm its status
EvanstonUnited StatesRecruiting
University of California San Diego
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Mount Sinai Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
Oregon Health Sciences University
Coordinator of this site? Confirm its status
PortlandUnited StatesNot yet recruiting
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.