Gleason <6 (G6) prostate cancer (PC) at radical prostatectomy (RP): Does a high-risk setting truly exist? A recursive partitioning analysis (RPA).
132 Background: G6PC is associated with low rates of PSA failure (bF) after primary treatment. The present study seeks to determine whether a "high-risk" subpopulation of G6PC with lower PSA relapse-free survival (bRFS) may be identified within a large population of men with mature follow-up who underwent RP for curative-intent. Methods: Patients were retrospectively identified for inclusion by cT1-2 PC with PSA <30 at diagnosis, managed by RP alone, with final pathology demonstrating G6PC. Exclusion criteria were: pT3b or pN1, pre- or post-RP (adjuvant) radiotherapy (RT) or hormone therapy, or PSA follow-up (<12 months). The Kaplan-Meier method was employed for survival probability estimation. RPA by conditional inference analysis was applied to identify variables associated with bF. Results: From 2003-2009, 284 patients were eligible for this analysis. The median age was 60 yrs (range, 44-76), 233 (82%) were T1c, and median PSA was 5.3 (92% <10 ng/dL). The median biopsy to RP interval was 50 days (11-410, with 97% <180 days). Eighty patients (28%) had a positive margin (M+). At a median follow-up of 92.6 months (16.9-160.9, with 45% followed >8 years), 32 patients (11%) had bF, with estimated 5/8yr bRFS rates of 91%/89%. Univariate analysis identified M+, EPE, detectable initial post-RP PSA (at <26wks post-RP), longer biopsy to RP interval, and smaller RP specimen volume as significantly associated with bF, with M+ and longer biopsy to RP interval significant at multivariate analysis. RPA identified only M+ as a stratification factor, with 5/8yr bRFS estimates of 79/74% for M+ vs. 96/95% for M-. No other factors permitted further substratification of risk. Of note, 7 of 12 patients who underwent salvage RT alone remained disease-free at last follow-up, including 7 of 8 whose highest pre-salvage RT PSA was <0.6. Conclusions: G6PC managed by RP alone is generally associated with high rates of bRFS; however, in the M+ setting, irrespective of other clinical factors, early bF rates >20% are observed. Adjuvant RT should be considered in G6PC M+ cases; however, close surveillance with early salvage RT may be a reasonable alternative.