PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness

Overview

PROMISE aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, PSA greater than 100 ng/dL and/or radiographic evidence of disease and receiving systemic therapy for prostate cancer. Patients at all stages of disease will be welcome to participate in the PROMISE Registry. Participants will be recruited \& screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results. Participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures. PROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data. Participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants. Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years. 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. For more information, visit the study website at: prostatecancerpromise.org

Primary outcome measures

• Frequency of at least one germline pathogenic or likely pathogenic variant [Time frame: 5 years]

Secondary outcome measures (6)

• Frequency of pathogenic or likely pathogenic germline variants of interest [Time frame: 5 years]
• Identify and recruit control group of patients with a variant of uncertain significance (VUS) [Time frame: 5 years]
• Association between disease characteristics and genetic variants [Time frame: 15 years]
• Analysis of patient reported outcomes (PRO) measures [Time frame: 15 years]
• Analysis of longitudinal outcome data [Time frame: 15 years]
• Comparison of overall survival [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

• Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:

• tissue biopsy, and/or
• PSA greater than 100 ng/dL (1ng/ml), and/or
• clear radiographic evidence of disease
• Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)

Exclusion criteria

• Unable or unwilling to provide all of the necessary information for eligibility
• Incomplete inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 3 centers

• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
• Memorial Sloan Kettering Cancer Center — New York
• University of Washington Medical Center — Seattle

Identifiers

NCT: NCT04995198 · c19-235

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗