An initial serum PSA level less than 5 ng/ml at diagnosis does not correlate with tumor volume in low risk prostate cancer patients. Implications for conservative treatment. A.Nini, A. Briganti, N. Suardi, A. Gallina, F. Abdollah, D. Di Trapani, G. La Croce, P. Dell’Oglio, N. Fossati, R. Colombo. G. Guazzoni, P. Rigatti, F. Montorsi. Introduction & objectives Active surveillance is a valid management strategy for newly diagnosed low risk prostate cancer (PCa). In fact a well differentiated, low volume tumor can be identified based on initial patient characteristic at diagnosis. However, the association between baseline parameters such as PSA and tumor volume has been poorly studied in patients with low risk disease. The aim of the study was to assess whether PSA levels accurately predicts tumor volume in low risk PCa patients who are candidates for non invasive treatment. Materials & Methods. We analyzed complete data of 1933 pts treated with radical prostatectomy (RP) at a single tertiary referral center between 2004 and 2010. Of these, 714 (36.9%) had pre-operative low risk PCa (cT1, PSA ≤10 ng/ml and biopsy Gleason score ≤6). Patients were divided into 2 groups: PSA≤5 ng/ml (n=266; 37.3%; Group 1) and >5ng/ml (n=448; 62.7%; Group 2). All pts had complete data, including tumor volume at RP. The correlation between PSA at diagnosis and tumor volume was examined using univariable and multivariable linear regression models, after accounting for ultrasound measured prostate volume. The same analyses were repeated separately in each group. Pts and tumor characteristics are reported as mean ± SD. Results. PSA at diagnosis was 5.76 ± 1.99 ng/ml, while mean tumor volume was 3.07 ± 2.97 cc (range 0.1-24 cc). Mean tumor volume was 2.42 ± 2.31 cc (range 0.215.5 cc) and 3.46 ± 3.24 cc (range 0.1-24 cc) for patients with PSA≤ 5 ng/ml and those with PSA >5 ng/ml, respectively (p=0.001). Overall, PSA represented independent predictors of tumor volume at RP (p<0.001, β 0.237). A positive association between PSA and tumor volume was confirmed in the sub-group of patients with PSA between 5 and 10 ng/ml both at univariable and multivariable analyses (all p<0.001). Conversely, in pts with PSA<5 ng/ml at diagnosis, no association between baseline PSA and tumor volume was found either at univariable (p=0.09) or at multivariable analysis (p=0.16). Prostate volume also failed to predict tumor volume in this patient category (p=0.39). Conclusion. While higher serum PSA level at the time of diagnosis of low risk PCa appears to accurately predict larger tumor volumes, this statement does not hold true for PSA levels below 5 ng/ml. The assumption that patients with low risk disease and low PSA values at the time of diagnosis have small tumor volumes must thus be made with caution if the initial PSA drops below this cut-off value. Other variables beside PSA should be used for the prediction of insignificant prostate cancer in patients with low PSA values.