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

NCT04995198 | Recruiting

• 1 other identifier: c19-235
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of at least one germline pathogenic or likely pathogenic variant

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

  5 years

Secondary Outcomes (6)

• Frequency of pathogenic or likely pathogenic germline variants of interest

  5 years

• Identify and recruit control group of patients with a variant of uncertain significance (VUS)

  5 years

• Association between disease characteristics and genetic variants

  15 years

• Analysis of patient reported outcomes (PRO) measures

  15 years

• Analysis of longitudinal outcome data

  15 years

Study Arms (2)

Participants with at least one germline pathogenic/likely pathogenic variant

Participants with at least one variant of uncertain significance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with prostate cancer (any stage of disease or survivorship). Individuals are eligible whether they have had prior germline genetic testing or not.

You may qualify if:

• 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)

You may not qualify if:

• Unable or unwilling to provide all of the necessary information for eligibility

Sponsors & Collaborators

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

Study Sites (3)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Links

• PROMISE Study Site

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, Blood (optional), Tissue (optional)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Heather Cheng, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Channing Paller, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Vinson

CONTACT

646-449-3363; pcctcpromise@mskcc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: May 3, 2021
• Primary Completion: February 26, 2026
• Study Completion (Estimated): February 26, 2036
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)