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Prostate Cancer Registry of Outcomes and Germline Mutations (PROMISE) (PROMISE)

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ClinicalTrials.gov Identifier: NCT04995198
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Fred Hutchinson Cancer Research Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Advancing Cancer Treatment, Inc.
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

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.


Condition or disease
Prostate Cancer

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
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
Estimated Primary Completion Date : February 26, 2026
Estimated Study Completion Date : February 26, 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Biospecimen Retention:   Samples With DNA
Saliva, Blood (optional), Tissue (optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with localized, biochemically recurrent, and metastatic prostate cancer who either have or have not had prior germline genetic testing.
Criteria

Inclusion Criteria:

  • Documented evidence of prostate cancer through:

    • tissue biopsy,
    • PSA greater than 100 ng/dL, and/or
    • clear radiographic evidence of disease
  • Resident of the United States, as of the date of consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995198


Contacts
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Contact: Jacob Vinson 646-449-3363 pcctcpromise@mskcc.org

Locations
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United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Heather Cheng, MD         
Principal Investigator: Heather Cheng, MD         
Sponsors and Collaborators
Prostate Cancer Clinical Trials Consortium
Memorial Sloan Kettering Cancer Center
Fred Hutchinson Cancer Research Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Advancing Cancer Treatment, Inc.
Investigators
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Principal Investigator: Heather Cheng, MD, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Channing Paller, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional Information:
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Responsible Party: Prostate Cancer Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT04995198    
Other Study ID Numbers: c19-235
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Prostate Cancer
Genetics
Registry
Germline Mutation
Genetic Testing
Germline Testing
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases