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Active Not Recruiting NCT04404894

Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing

Conditions: Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Myriad Genetic Laboratories, Inc.

Location: Urology Centers of Alabama Homewood Alabama

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 treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04404894). StuddyBuddy aggregates publicly available trial information.