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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Active Surveillance (AS) selection versus Definitive Therapy (DT — 1 Year The primary endpoint of the registry is Active Surveillance selection, defined as the proportion of all men who select Active Surveillance in lieu of definitive therapy following confirmatory diagnosis of localized Prostate Cancer and Prolaris testing. Active Surveillance selection is
documented by the treating provider and reflects the patient-provider decision at the time to pursue Active Surveillance with no curative intent.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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