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Nationwide enrollment has started for the Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness (PROMISE) observational study examining germline pathogenic variants in patients with prostate cancer.1,2
“If we want to better understand prostate cancer, we have to better understand genes. This information is the next step in our collective fight against the disease,” Heather Cheng, PhD, co-lead investigator of the PROMISE trial and associate professor of medical oncology at the University of Washington School of Medicine; director of the Prostate Cancer Genetics Clinic at Seattle Cancer Care Alliance; and a faculty member at Fred Hutchinson Cancer Research Center, stated in a recent news release.
The long-term PROMISE study (NCT04995198) requires that individuals provide an initial saliva sample that screens for 30 cancer risk genes, a baseline demographic survey outlining family history, a medical record examination, and a follow-up every 6 months for at least 15 years. Participants register online, receive a home-based DNA test kit for their saliva sample, and send it to study investigators through prepaid US mail. The trial is free for its participants, who can continue to see their current health care provider throughout the course of the study.
To enroll in the trial, participants must be males at least 18 years of age and have a confirmed prostate cancer diagnosis via tissue biopsy, prostate specific antigen (PSA) greater than 100 ng/dL and/or radiographic evidence of the disease. In addition, participants must reside in the United States and be receiving systemic therapy for prostate cancer. The estimated enrollment for this study is 500 participants and patient recruitment and screenings will take place over a 5-year period.
The primary end point of the PROMISE study is pathogenic germline variant frequency, with secondary end points being pathogenic germline variant frequency (of variants of interest), variants of uncertain significance, association between disease characteristics and genetic variants, patient reported outcomes, longitudinal outcome data, and overall survival.
The estimated study completion date for the PROMISE study is February 2036. Locations include Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, Memorial Sloan Kettering Cancer Center, New York, New York, and University of Washington Medical Center, Seattle, Washington.
Eligible participants will receive free genetic testing and counseling that will determine potential gene mutation and propose plans for treatment. Investigators strongly encourage patients at all ages of disease to participate.
Cheng’s co-lead investigator on the PROMISE trial is Channing Paller, MD, associate professor of oncology and urology at Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center and associate director for oncology of the Johns Hopkins Clinical Research Network.
“The PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for,” the investigators wrote in a summary on the study’s ClinicalTrials.gov site.
1. First-of-its-Kind Study Looks at Link Between Genes and Prostate Cancer. Published online August 26, 2021. Accessed September 3, 2021. https://prn.to/3tdpjBW.
2. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Prostate Cancer Registry of Outcomes and Germline Mutations (PROMISE). Updated August 6, 2021. Accessed September 3, 2021. https://clinicaltrials.gov/ct2/show/NCT04995198