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NCT03511235 · ClinicalTrials.gov registry record
Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
A clinical trial of Prostate Cancer, sponsored by Myriad Genetic Laboratories.
- Completed
- Registry status
- 774
- Enrollment target
- 8
- Study locations
NCT03511235: Completed study of Prostate Cancer, sponsored by Myriad Genetic Laboratories.
NCT03511235 is a study of Prostate Cancer that has completed, run by Myriad Genetic Laboratories. The registered enrollment target is 774 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (28% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511235, a study of Prostate Cancer, has completed, sponsored by Myriad Genetic Laboratories.
- COMPLETED
- Registry status
- 774 participants
- Enrollment target
- 8
- Study locations
Study Summary
Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.
Primary Outcome
This study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men.
Conditions Studied
Study Locations (8)
California
- Pacific Urology - Concord
- Kar Urology - Orange
- Golden Gate Urology - San Francisco
Arkansas
- Arkansas Urology - Little Rock
Colorado
- Urological Associates - Colorado Springs
Michigan
- University of Michigan Urology Cancer Center - Ann Arbor
Missouri
- Dr. Jeffrey Glaser, Urologist - Lake Saint Louis
New York
- Memorial Sloane Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 774 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2018-07-31 |
What the finished NCT03511235 record still lists
NCT03511235 is an observational study that tracks outcomes without assigning an intervention. The registered 774 participants enrollment target is mid-sized for trials with a published cap, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (28% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT03511235 lists 8 locations in 6 states (California, Arkansas, Colorado).
Frequently Asked Questions
What is clinical trial NCT03511235 about?
NCT03511235 is a clinical study titled "Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing". Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding...
What is the current status of trial NCT03511235?
This trial is currently completed. The enrollment target is 774 participants. The study started on 2018-03-12. Estimated completion is 2018-07-31.
What conditions does trial NCT03511235 study?
This clinical trial studies the following conditions: Prostate Cancer.
Who is sponsoring clinical trial NCT03511235?
This trial is sponsored by Myriad Genetic Laboratories, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03511235 being conducted?
This trial has 8 study locations across Arkansas, California, Colorado, Michigan, Missouri. 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 NCT03511235's enrollment target sits among peer trials
774 82nd of 735 higher than 654 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.
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