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NCT04995198 · ClinicalTrials.gov registry record
PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
A clinical trial of Prostate Cancer, sponsored by Prostate Cancer Clinical Trials Consortium.
- Recruiting
- Registry status
- 500
- Enrollment target
- 3
- Study locations
NCT04995198: Recruiting study of Prostate Cancer, sponsored by Prostate Cancer Clinical Trials Consortium.
NCT04995198 is a study of Prostate Cancer that is actively recruiting participants, run by Prostate Cancer Clinical Trials Consortium. The registered enrollment target is 500 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04995198, a study of Prostate Cancer, is actively recruiting participants, sponsored by Prostate Cancer Clinical Trials Consortium.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 3
- Study locations
Study 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: pro
Primary Outcome
Frequency of having at least one germline pathogenic or likely pathogenic variant in a cancer risk gene based on the number of subjects screened.
Conditions Studied
Study Locations (3)
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
New York
- Memorial Sloan Kettering Cancer Center - New York
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2036-02-26 |
What NCT04995198 shows while recruiting
NCT04995198 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT04995198 reports a single indexed study location in Maryland, New York, Washington.
Frequently Asked Questions
What is clinical trial NCT04995198 about?
NCT04995198 is a clinical study titled "PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness". 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 ev...
What is the current status of trial NCT04995198?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2021-05-03. Estimated completion is 2036-02-26.
What conditions does trial NCT04995198 study?
This clinical trial studies the following conditions: Prostate Cancer.
Who is sponsoring clinical trial NCT04995198?
This trial is sponsored by Prostate Cancer Clinical Trials Consortium, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04995198 being conducted?
This trial has 3 study locations across Maryland, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04995198's enrollment target sits among peer trials
500 105th of 735 higher than 623 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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