NCT Number: NCT04995198
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
Interested in participating?
Request Info18 year and older
Male
Observational
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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, BARD1, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2.
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.
Time frame: 15 years
Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.
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.
Time frame: 15 years
Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.
Contact information is provided by the study sponsor or research team.
Prostate Cancer Clinical Trials Consortium
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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