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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995198
• Other study ID #: c19-235
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: February 26, 2036

Study information

• Verified date: December 2023
• Source: Prostate Cancer Clinical Trials Consortium
• Contact: Jacob Vinson
• Phone: 646-449-3363
• Email: pcctcpromise[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 26, 2036
• Est. primary completion date: February 26, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Genetic Testing
Germline genetic testing via Color Health's Hereditary Cancer Panel.
• Genetic Counseling
A Genetic Counselor will review results with participants and discuss clinical implications and recommendations.
• Patient Reported Outcome Measures
Participants will complete the EORTC QLQ-C30 questionnaire every 6 months.

Locations

Country	Name	City	State
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Prostate Cancer Clinical Trials Consortium	Advancing Cancer Treatment, Inc., Fred Hutchinson Cancer Center, Memorial Sloan Kettering Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Comparison of overall survival	Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.	15 years

External Links

•   PROMISE Study Site