NCT04995198 PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
| NCT ID | NCT04995198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prostate Cancer Clinical Trials Consortium |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-05-03 |
| Primary Completion | 2026-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-05-03 with a primary completion date of 2026-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. For more information, visit the study website at: prostatecancerpromise.org
Eligibility Criteria
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
Contact & Investigator
Heather Cheng, MD, PhD
PRINCIPAL INVESTIGATOR
Fred Hutchinson Cancer Center
Frequently Asked Questions
Who can join the NCT04995198 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04995198 currently recruiting?
Yes, NCT04995198 is actively recruiting participants. Contact the research team at pcctcpromise@mskcc.org for enrollment information.
Where is the NCT04995198 trial being conducted?
This trial is being conducted at Baltimore, United States, New York, United States, Seattle, United States.
Who is sponsoring the NCT04995198 clinical trial?
NCT04995198 is sponsored by Prostate Cancer Clinical Trials Consortium. The principal investigator is Heather Cheng, MD, PhD at Fred Hutchinson Cancer Center. The trial plans to enroll 500 participants.
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