RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-05-03
Study Completion:2036-02-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04995198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:
  2. * tissue biopsy, and/or
  3. * PSA greater than 100 ng/dL (1ng/ml), and/or
  4. * clear radiographic evidence of disease
  5. * Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)
  1. * Unable or unwilling to provide all of the necessary information for eligibility
  2. * Incomplete inclusion criteria

Contacts and Locations

Study Contact

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

Principal Investigator

Heather Cheng, MD, PhD
PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Channing Paller, MD
PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Locations (Sites)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Prostate Cancer Clinical Trials Consortium

  • Heather Cheng, MD, PhD, PRINCIPAL_INVESTIGATOR, Fred Hutchinson Cancer Center
  • Channing Paller, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-03
Study Completion Date2036-02-26

Study Record Updates

Study Start Date2021-05-03
Study Completion Date2036-02-26

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Genetics
  • Registry
  • Germline Mutation
  • Genetic Testing
  • Germline Testing

Additional Relevant MeSH Terms

  • Prostate Cancer