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

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

Clinicaltrials.gov identifier:
NCT04995198

Surveys, Registries, Interviews

Study Contact Information:

Contact the study coordinator at this email:

Study phone line: 646-449-3363


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

About the Study

PROMISE is a nationwide registry of prostate cancer patients with inherited mutations by screening approximately 5,000 participants with a prostate cancer diagnosis.

The PROMISE team is studying how these mutations affect patient outcomes. We hope to help patients learn more about their disease, the treatments that they may benefit most from, and any research studies that they may be eligible for.

Visit prostatecancerpromise.org to learn more about the study and sign up.

What the Study Entails

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.
    • Genetic testing and the genetic counselor appointment are free.
  • Fill out a 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) to obtain clinical data.
  • Participants with certain inherited 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.
  • Participants will receive newsletters twice a year with information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants.

PROMISE is completely free. Participants don’t have to leave their current healthcare provider or their house to join.

Lead Researchers and Affiliation

Co-PI: Heather Cheng, MD PhD

Fred Hutchinson Cancer Research Center

University of Washington

 

Co-PI: Channing Paller, MD

Sidney Kimmel Comprehensive Cancer Center

Johns Hopkins University

Study Sponsor and Coordinating Center: Prostate Cancer Clinical Trials Consortium

This Study is Open To:
  1. Assigned male at birth
  2. 18 years of age and above  
  3. Documented evidence of prostate cancer through:
    • tissue biopsy,
    • PSA greater than 100 ng/dL, and/or
    • clear radiographic evidence of disease
  4. Must live in the United States (including the US territories), as of the date of consent
This Study is Not Open To:
  1. Unable or unwilling to provide all of the necessary information for eligibility
  2. Incomplete eligibility criteria