Clinical trial · Observational
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Prolaris tested patients with Prostate Cancer
- description
- Recently diagnosed patients with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites who have undergone Prolaris testing.
Primary outcomes (1)
- measure
- Active Surveillance (AS) selection versus Definitive Therapy (DT
- timeFrame
- 1 Year
- description
- 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.
Secondary outcomes (1)
- measure
- Active Surveillance Durability; Comorbidities
- timeFrame
- Active Surveillance durability, date of diagnostic biopsy will be recorded as the Active Surveillance initiation date. Definitive treatments collected at baseline and annually up to 10 years Comorbidities collected annually up to 10 years.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available