Recruiting

Genomics

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04706663

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT04706663

Start date

Sep 14, 2021

Status verified date

Aug 21, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Subjects with histologically confirmed prostate cancer and genomic testing results

Cohort 2

Subjects with histologically confirmed prostate cancer who deemed to be an exceptional responder with or without genomic testing results

Primary outcome measure

  • natural history of prostate cancer with known germline and/or somatic variants [ Time Frame: ongoing ]
  • natural history of TMB-H prostate cancer [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Dana Farber Cancer Institute, Boston, MA

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10007

Contacts

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 25, 2026

Last verified

Aug 21, 2026

Keywords

  • germline variants
  • somatic variants
  • Genetic Predisposition
  • Molecular Genetics
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-25.