Observational Study of Genomics in Prostate Cancer

This observational study is looking at the natural history (how a disease progresses without intervention) of prostate cancer in men who have specific genetic changes. Researchers want to understand how these genetic changes, called variants, relate to how prostate cancer develops and responds to treatment. They are studying variants in genes like BRCA1, BRCA2, and others, as well as tumor mutational burden (TMB), which is a measure of how many mutations are in a tumor. You may be able to join if you are an adult male (18 or older) with prostate cancer and have certain known genetic variants. The study aims to follow the course of your prostate cancer over time to better understand these genetic links.

Study design
This is an observational study, meaning researchers will watch the natural course of the disease without providing any specific interventions. It plans to include up to 2000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will observe the natural history of prostate cancer with known genetic variants and TMB-H (high tumor mutational burden) on an ongoing basis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04706663

Precision-Based Genomics in Prostate Cancer

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~2,000 participants
Updated 2026-08-25 on ClinicalTrials.gov

At a glance

Recruiting sites
7 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
natural history of prostate cancer with known germline and/or somatic variants
Measured over ongoing
+1 more outcome measured
Prostate Cancer
11 sites across 8 states
New York3
California2
Illinois1
Maryland1
Massachusetts1
Michigan1
Oregon1
Washington1
  • Fatima H Karzai, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

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)
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

None
  • natural history of prostate cancer with known germline and/or somatic variantsongoing

    clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival

  • natural history of TMB-H prostate cancerongoing

    clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival