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
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
|Participants with at least one germline pathogenic/likely pathogenic variant|
|Participants with at least one variant of uncertain significance|
- 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.
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Jacob Vinsonfirstname.lastname@example.org|
|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|
|Principal Investigator:||Heather Cheng, MD, PhD||Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Channing Paller, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|