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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants with at least one germline pathogenic/likely pathogenic variant
Participants with at least one variant of uncertain significance

Recruiting Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21231
Contact:
Channing Paller, MD

Memorial Sloan Kettering Cancer Center
New York, New York 10065

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Heather Cheng, MD

More Details

Status
Recruiting
Sponsor
Prostate Cancer Clinical Trials Consortium

Study Contact

Jacob Vinson
646-449-3363
pcctcpromise@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.