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

NCT04995198 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-08-07

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    collaborator OTHER

  • Advancing Cancer Treatment, Inc.

    collaborator UNKNOWN

  • Prostate Cancer Clinical Trials Consortium

    lead OTHER

Principal Investigators

  • Heather Cheng, MD, PhD · Fred Hutchinson Cancer Center

  • Channing Paller, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2026-02-26
Completion
2036-02-26

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995198 on ClinicalTrials.gov