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

Sponsor
Prostate Cancer Clinical Trials Consortium (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995198
Collaborator
Memorial Sloan Kettering Cancer Center (Other), Fred Hutchinson Cancer Center (Other), Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other), Advancing Cancer Treatment, Inc. (Other)
500
3
177.8
166.7
0.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
    Actual Study Start Date :
    May 3, 2021
    Anticipated Primary Completion Date :
    Feb 26, 2026
    Anticipated Study Completion Date :
    Feb 26, 2036

    Arms and Interventions

    Arm Intervention/Treatment
    Participants with at least one germline pathogenic/likely pathogenic variant

    Participants with at least one variant of uncertain significance

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of at least one germline pathogenic or likely pathogenic variant [5 years]

      Frequency of having at least one germline pathogenic or likely pathogenic variant in a cancer risk gene based on the number of subjects screened.

    Secondary Outcome Measures

    1. Frequency of pathogenic or likely pathogenic germline variants of interest [5 years]

      Frequency of pathogenic or likely pathogenic germline variants of interest in subjects with prostate cancer. We will estimate the frequency of having each of the germline pathogenic or likely pathogenic variant in the cancer risk genes based on the number of subjects screened in each subpopulation.

    2. Identify and recruit control group of patients with a variant of uncertain significance (VUS) [5 years]

      Identify and recruit a control group of patients with a VUS in their clinical or research results in the following genes: ATM, ATR, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2.

    3. Association between disease characteristics and genetic variants [15 years]

      Collect data on disease characteristics and examine the association between disease characteristics and pathogenic and likely pathogenic germline variants and VUS of interest.

    4. Analysis of patient reported outcomes (PRO) measures [15 years]

      Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.

    5. Analysis of longitudinal outcome data [15 years]

      Collect longitudinal outcome data on subjects with pathogenic and likely pathogenic germline variants and VUS of interest, for specific treatments, treatment sequences or therapy combinations used for treating prostate cancer.

    6. Comparison of overall survival [15 years]

      Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21231
    2 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    3 University of Washington Medical Center Seattle Washington United States 98195

    Sponsors and Collaborators

    • Prostate Cancer Clinical Trials Consortium
    • Memorial Sloan Kettering Cancer Center
    • Fred Hutchinson Cancer Center
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Advancing Cancer Treatment, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Prostate Cancer Clinical Trials Consortium
    ClinicalTrials.gov Identifier:
    NCT04995198
    Other Study ID Numbers:
    • c19-235
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prostate Cancer Clinical Trials Consortium
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022