Background: In this study, the authors evaluated whether a clinically relevant stratification of prostate specific antigen (PSA) failure free survival (bNED) after definitive local therapy could be made for patients with prostate carcinoma clinically classified as T1 or T2 and pretreatment PSA levels of 4-20 ng/mL.
Methods: Multivariate Cox regression analysis and Kaplan-Meier analysis were performed for clinically localized prostate carcinoma patients who presented with PSA levels of 4-20 ng/mL. Three hundred forty-eight of the patients were managed definitively with conventional external beam radiation therapy (median dose, 67 gray), whereas 547 of the patients were managed definitively with a radical retropubic prostatectomy. The outcome tested was time to posttreatment PSA failure. The clinical predictors evaluated included the standard paradigm (PSA, biopsy Gleason score, and clinical stage); type of local therapy; and a newly defined factor, the calculated prostate cancer volume (cV[Ca]).
Results: Time to posttreatment PSA failure was equivalent (P = 0.52) independent of the type of local therapy. The cV(Ca) (P < 0.0001), pretreatment PSA (P = 0.003), and clinical classification of T2c (P = 0.04) remained significant predictors of time to posttreatment PSA failure in multivariate analysis.
Conclusions: The staging system described herein, which is based on cV(Ca) and PSA, may optimize patient selection for definitive local therapy and entry onto randomized clinical trials examining the use of adjuvant hormonal or chemotherapy in patients with clinically localized disease who present with PSA levels of 4-20 ng/mL. Validation of this staging system by other investigators is currently underway.