Status:
ACTIVE_NOT_RECRUITING
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select trea...
Detailed Description
To evaluate use of the Prolaris score in treatment management decisions in an ethnically and racially diverse population of men who have been newly diagnosed with prostate cancer and who are potential...
Eligibility Criteria
Inclusion
- Age 18 years or older on date of enrollment.
- Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.
- Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.
- Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
Exclusion
- Estimated life expectancy \< 10 years.
- Clinical evidence of metastasis or lymph node involvement.
- Received pelvic radiation prior to biopsy.
- Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha- reductase inhibitor (5-ARI) use is permitted.
- Plan to use PrCa-specific prognostic testing other than PSA for treatment decision making during Active Surveillance.
- Currently participating in an interventional clinical trial.
- Unable to provide routine clinical informed consent.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04404894
Start Date
April 30 2020
End Date
November 1 2029
Last Update
July 14 2025
Active Locations (7)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
3
Manatee Medical Research Institute
Bradenton, Florida, United States, 34205
4
UroPartners, LLC
Westchester, Illinois, United States, 60440