Real-World Use of Prolaris® to Guide Treatment Decisions in Localized Prostate Cancer Eligible for Active Surveillance

Introduction: Active surveillance (AS) is the guideline-recommended management strategy for low-risk and favorable intermediate-risk prostate cancer (PCa). However, conventional risk stratification remains limited in predictive accuracy. Robust real-world evidence on the clinical utility of the cell cycle risk (CCR; Prolaris®) score within European healthcare settings is currently scarce. Methods: We performed a retrospective single-center study of 60 localized PCa patients who underwent CCR testing at a tertiary academic urologic center between 2021 and 2025. We analyzed indications for testing, CCR treatment recommendations, and adherence rates using descriptive statistics. Results: Median patient age was 62 years, and median prostate-specific antigen level was 5.76 ng/mL. Overall, 13.3% of biopsy cores were positive, and 93.3% of patients had a Gleason score of 6. CCR testing was performed after initial diagnosis in 61.7% of patients and during ongoing AS in 38.3%. Following CCR testing, definitive therapy was recommended in 21.7% of patients, with an adherence rate of 53.8%, whereas continued AS was recommended in 78.3% of patients, with an adherence rate of 87.2%. Conclusion: CCR testing demonstrated high adherence rates, particularly for AS recommendations in the real-world setting. These findings support Prolaris® as a complementary decision aid for AS patient selection and management.

Accurately distinguishing prostate cancer patients who are suitable for active surveillance from those requiring active treatment remains challenging. We evaluated the clinical utility of the Prolaris® assay quantifying expression of cell cycle-related genes to estimate tumor proliferative potential in routine practice in 60 patients who underwent testing and assessed its impact on physicians’ treatment recommendations. Treatment recommendations changed after testing in one-fifth of patients. When the test recommended continued monitoring, the recommendation was very likely to be followed (87.2% compliance). However, when it recommended surgery or radiation, fewer patients followed the recommendation (53.8% compliance). Summarizing, Prolaris® is helpful for guiding treatment decisions in real-world practice.