(UroToday.com) A substantial minority of patients with prostate cancer have germline mutations in genes involved in DNA damage repair. Based on the prevalence of these alterations in advanced disease and the potential therapeutic benefit of targeting germline DNA damage repair vulnerabilities, treatment guidelines recommend genetic testing in high-risk localized, node positive, and metastatic disease.
To obtain a broader real-world understanding of the prevalence of potentially targetable DNA damage repair alterations as well as the efficacy of therapies such as PARP inhibitors, the PROMISE registry effort aims to screen 5,000 prostate cancer patients to identify and enroll 500 patients (based on estimated 10% prevalence) with germline variants that are known pathogenic, likely pathogenic, or of unknown significance in selected DNA damage repair genes (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, FAM175A, GEN1, HOXB13, MRE11A, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, PTEN, RAD51C, RAD51D, TP53 and XRCC2).
Patients with serologic, biopsy or radiographic evidence of prostate cancer are eligible. After enrollment, patients will receive genetic counseling and routine information updates on relevant treatments and trials. Patient report outcomes surveys and medical record abstraction will be updated every six months. The data gathered from this registry will provide a cohort of patients with pathogenic or likely pathogenic germline variants in the above genes, a control cohort of patients with variants of unknown significance in these genes, and patient-reported as well as clinical outcomes longitudinally. The registry will recruit over five years, with fifteen years of planned follow-up, and is run under clinical trial ID NCT04995198.
Presented By: Channing Judith Paller, MD, medical oncologist at the Johns Hopkins University School of Medicine, Baltimore, MD
Written By: Alok K. Tewari, MD, PhD, medical oncologist at Dana-Farber Cancer Institute, @aloktewar on Twitter during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022