PROMISE Registry: A prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness.

Recently approved treatments and updates to genetic testing recommendations for prostate cancer have created a need for correlated analyses of patient outcomes data via germline genetic mutation status. Genetic registries address these gaps by identifying candidates for recently approved targeted treatments, expanding clinical trial data examining specific gene mutations, and understanding effects of targeted treatments in the real-world setting.

The PROMISE Registry is a 20-year (5-year recruitment, 15-year follow-up), US-wide, prospective genetic registry for prostate cancer patients. Five thousand patients will be screened through an online at-home germline testing to identify and enroll 500 patients with germline mutations, including: pathogenic or likely pathogenic variants and variants of uncertain significance in genes of interest. Patients will be followed for 15 years and clinical data with real time patient reported outcomes will be collected. Eligible patients will enter long-term follow-up (6-month PRO surveys and medical record retrieval). As a virtual study with patient self-enrollment, the PROMISE Registry may fill gaps in genetics services in underserved areas and for patients within sufficient insurance coverage.

The PROMISE Registry opened in May 2021. 2114 patients have enrolled to date across 48 US states and 23 recruiting sites. 202 patients have met criteria for long-term follow-up. PROMISE is on target with the study's goal of 5000 patients screened and 500 patients eligible for long-term follow-up by 2026.

The PROMISE Registry is a novel, prospective, germline registry that will collect long-term patient outcomes data to address current gaps in understanding resulting from recently FDA-approved treatments and updates to genetic testing recommendations for prostate cancer. Through inclusion of a broad nationwide sample, including underserved patients and those unaffiliated with major academic centers, the PROMISE Registry aims to provide access to germline genetic testing and to collect data to understand disease characteristics and treatment responses across the disease spectrum for prostate cancer with rare germline genetic variants.

The Prostate. 2023 Nov 14 [Epub ahead of print]

Channing J Paller, Pedro C Barata, Justin Lorentz, Leonard J Appleman, Andrew J Armstrong, Tiffani A DeMarco, Robert Dreicer, Jo Ann B Elrod, Mark Fleming, Christopher George, Elisabeth I Heath, Maha H A Hussain, Shifeng Mao, Rana R McKay, Alicia K Morgans, Matthew Orton, Roberto Pili, Elyn Riedel, Biren Saraiya, Joelle Sigmond, Alexandra Sokolova, Walter M Stadler, Christina Tran, Natalie Macario, Jacob Vinson, Rebecca Green, Heather H Cheng, PROMISE Trial Investigators

Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., University Hospitals Seidman Cancer Center, Cleveland, Ohio, USA., Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, USA., Duke Cancer Institute Center for Prostate & Urologic Cancers, Durham, North Carolina, USA., Inova Translational Medicine Institute, Fairfax, Virginia, USA., University of Virginia Comprehensive Cancer Center, Charlottesville, Virginia, USA., Fred Hutchinson Cancer Center, Clinical Research Division, Seattle, Washington, USA., Virginia Oncology Associates, Norfolk, Virginia, USA., Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, USA., Department of Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan, USA., Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania, USA., Department of Oncology, University of California San Diego Moores Cancer Center, La Jolla, California, USA., Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Indiana University Health Arnett Cancer Center, Lafayette, Indiana, USA., Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA., Prostate Cancer Clinical Trials Consortium, New York, New York, USA., Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA., Cleveland Clinic, Akron, Ohio, USA., Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, USA., Department of Medicine, The University of Chicago Comprehensive Cancer Center, The University of Chicago Medicine, Chicago, Illinois, USA.