Understanding gene mutations in prostate cancer
A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer
This study is looking at gene changes in men with prostate cancer to see how these changes affect the disease and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 11 sites (La Jolla, California and 10 other locations) |
| Trial ID | NCT04706663 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate gene mutations in men diagnosed with prostate cancer to better understand how these mutations influence disease progression and treatment responses. Researchers will review medical records and gene test results, and conduct interviews with participants to gather comprehensive data. The study focuses on identifying additional germline and somatic variants that may contribute to prostate cancer risk and aggressiveness, with the goal of informing future treatment strategies and biomarker development.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed prostate cancer and known germline or somatic variants related to the disease.
Not a fit: Patients without any identified gene mutations or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of prostate cancer genetics, potentially guiding more personalized treatment approaches for patients.
How similar studies have performed: Other studies have shown success in identifying genetic factors in prostate cancer, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California and 10 other locations
- 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)
Study contacts
- Principal investigator: Fatima H Karzai, M.D. — National Cancer Institute (NCI)
- Study coordinator: Katherine O Lee-Wisdom, R.N.
- Email: katherine.lee-wisdom@nih.gov
- Phone: (240) 858-3525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.