Precision-Based Genomics in Prostate Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 12, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Precision-Based Genomics in Prostate Cancer," is focused on understanding how certain gene changes might affect prostate cancer in men. Prostate cancer is the most commonly diagnosed cancer in men and is a leading cause of cancer-related deaths. Researchers are looking to identify specific gene mutations that could indicate a higher risk of developing prostate cancer and may also influence how aggressive the disease is and how well it responds to treatment. By studying these gene changes, the team hopes to improve care for men diagnosed with prostate cancer.

To participate in this study, men aged 18 and older must have prostate cancer and have specific gene mutations that the researchers are interested in. This includes individuals who have had successful treatment or stable disease for some time. Participants will not need to visit the National Institutes of Health (NIH) regularly, but they will be contacted every six months to check on their health. They may also provide blood and urine samples for further research. The study will follow participants for life to gather valuable data that could lead to new insights into prostate cancer treatment and outcomes.

Gender

MALE

Eligibility 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