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