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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04995198
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : June 30, 2022
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Fred Hutchinson Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Advancing Cancer Treatment, Inc.
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Tracking Information
First Submitted Date July 29, 2021
First Posted Date August 6, 2021
Last Update Posted Date June 30, 2022
Actual Study Start Date May 3, 2021
Estimated Primary Completion Date February 26, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2021)
Frequency of at least one germline pathogenic or likely pathogenic variant [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 29, 2021)
  • Frequency of pathogenic or likely pathogenic germline variants of interest [ Time Frame: 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.
  • Identify and recruit control group of patients with a variant of uncertain significance (VUS) [ Time Frame: 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.
  • Association between disease characteristics and genetic variants [ Time Frame: 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.
  • Analysis of patient reported outcomes (PRO) measures [ Time Frame: 15 years ]
    Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.
  • Analysis of longitudinal outcome data [ Time Frame: 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.
  • Comparison of overall survival [ Time Frame: 15 years ]
    Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
Official Title PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
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

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 15 Years
Biospecimen Retention:   Samples With DNA
Description:
Saliva, Blood (optional), Tissue (optional)
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.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Participants with at least one germline pathogenic/likely pathogenic variant
  • Participants with at least one variant of uncertain significance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 29, 2021)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 26, 2036
Estimated Primary Completion Date February 26, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jacob Vinson 646-449-3363 pcctcpromise@mskcc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04995198
Other Study ID Numbers c19-235
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Prostate Cancer Clinical Trials Consortium
Original Responsible Party Same as current
Current Study Sponsor Prostate Cancer Clinical Trials Consortium
Original Study Sponsor Same as current
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: Heather Cheng, MD, PhD Fred Hutchinson Cancer Center
Principal Investigator: Channing Paller, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Prostate Cancer Clinical Trials Consortium
Verification Date June 2022