Precision-Based Genomics in Prostate Cancer
Recruiting · NCT04706663 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Cancer Institute (NCI)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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)
- 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
Where it is running
11 locations listed across 8 US states.
- University of California San Diego - La Jolla, California, United States
- University of California San Francisco - San Francisco, California, United States
- NorthShore University HealthSystem - Evanston, Illinois, United States
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States
- Dana Farber Cancer Institute, Boston, MA - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Mount Sinai Hospital - New York, New York, United States
- Weill Cornell Medicine - New York, New York, United States
- Oregon Health Sciences University - Portland, Oregon, United States
- University of Washington - Seattle, Washington, United States