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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Genetic Testing; Behavioral: Genetic Counseling; Behavioral: Patient Reported Outcome Measures

• Study Type: Observational
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Vinson; Phone Number: 646-449-3363; Email: pcctcpromise@mskcc.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Principal Investigator: Channing Paller, MD
      • Contact: Channing Paller, MD
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center
      • Contact: Heather Cheng, MD
      • Principal Investigator: Heather Cheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants with at least one germline pathogenic/likely pathogenic variant
Participants with at least one variant of uncertain significance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of pathogenic or likely pathogenic germline variants of interest	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.	5 years
Association between disease characteristics and genetic variants	Collect data on disease characteristics and examine the association between disease characteristics and pathogenic and likely pathogenic germline variants and VUS of interest.	15 years
Analysis of patient reported outcomes (PRO) measures	Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.	15 years
Analysis of longitudinal outcome data	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.	15 years
Comparison of overall survival	Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.	15 years
Identify and recruit control group of patients with a variant of uncertain significance (VUS)	Identify and recruit a control group of patients with a VUS in their clinical or research results in the following genes: ATM, ATR, BARD1, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2.	5 years

Collaborators and Investigators

• Sponsor: Prostate Cancer Clinical Trials Consortium
• Collaborators: Memorial Sloan Kettering Cancer Center; Fred Hutchinson Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Advancing Cancer Treatment, Inc.
• Investigators: Principal Investigator: Channing Paller, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Principal Investigator: Heather Cheng, MD, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

Helpful Links

• PROMISE Study Site

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): February 26, 2026
• Study Completion (Estimated): February 26, 2036

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Genetics; Prostate Cancer; Registry; Genetic Testing; Germline Mutation; Germline Testing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: c19-235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No