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. 2024 Feb;84(3):292-302.
doi: 10.1002/pros.24650. Epub 2023 Nov 14.

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

Channing J Paller  1 , Pedro C Barata  2 , Justin Lorentz  3 , Leonard J Appleman  4 , Andrew J Armstrong  5 , Tiffani A DeMarco  6 , Robert Dreicer  7 , Jo Ann B Elrod  8 , Mark Fleming  9 , Christopher George  10 , Elisabeth I Heath  11 , Maha H A Hussain  10 , Shifeng Mao  12 , Rana R McKay  13 , Alicia K Morgans  14 , Matthew Orton  15 , Roberto Pili  16 , Elyn Riedel  17 , Biren Saraiya  18 , Joelle Sigmond  19 , Alexandra Sokolova  20 , Walter M Stadler  21 , Christina Tran  17 , Natalie Macario  17 , Jacob Vinson  17 , Rebecca Green  17 , Heather H Cheng  8   22 ; PROMISE Trial Investigators
Affiliations

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

Channing J Paller et al. Prostate. 2024 Feb.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: PROMISE; genetic testing; germline; prostate cancer; registry; targeted therapy.

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References

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