1. RISK OF NON SIGNIFICANT PROSTATE CANCER IN PROSTATE CANCER PATIENTS DIAGNOSED BY AN EXTENDED PROSTATE NEEDLE BIOPSY PROCEDURE AND TREATED BY RADICAL PROSTATECTOMY A. de la Taille (1), L. Salomon (1), G. Guichard (1), S. Beley (1), H. Faucon (1), Y. Allory (2), R. Yiou (1) JJ. Patard (3), D. Vordos (1), A. Hoznek (1), C. Abbou (1) Departments of Urology (1) and Pathology (2) - CHU Henri Mondor - Créteil, France Department of Uorlogy (3) - CHU Pontchaillou - Rennes, France Extended prostate biopsy protocol is associated with an increased prostate cancer (PC) detection rate. However, the risk of detecting non significant cancer (defined by tumor volume <0.5cc and Gleason score 6) could be also increased. Preoperatively, non significant PC can be suspected when patient has PSA <10ng/ml, T1c, Gleason <6 and one positive biopsy with less than 3mm of cancer on the core. We reviewed our PC patients treated by radical prostatectomy who had these criteria with an extended prostate needle biopsy protocol. Out of 819 patients included in our prospective clinical database of radical prostatectomy, 239 patients were diagnosed by using an extended 21-sample needle biopsy protocol (including sextant biopsies, 3 additional biopsies in each lateral peripheral zone (lateral), 3 biopsies in each transitional zone (TZ) and 3 biopsies in the midline peripheral zone). We selected patients with all criteria of non significant PC and with 1 positive biopsy out of the sextant biopsy (6 biopsies), out of the sextant and lateral biopsies (12 biopsies), out of the sextant, lateral and TZ biopsies (18biopsies) and out of all biopsies (21biopsies). Tumor volume was calculated. Mean age was 62 years, mean serum PSA 6.3ng/ml (2.6-9.9) and prostate volume 61.4cc (34-110). Table shows the number of pT3, Gleason>7 or tumor volume >0.5cc and the number of undiagnosed PC patients (i.e. PC diagnosed on the additional biopsies). Selection of patients by using preoperative criteria of non significant prostate cancer (T1c, PSA 7 and/or tumor volume>0.5cc) in more than half of the patients. Surprisingly, increasing the selection by the number of total biopsies leads to the same underestimation. These preoperative parameters are not enough to predict a non significant prostate Source of Funding: None Mondor protocol : 21 biopsies including sextant + 6 PB far lateral + 6 PB in TZ and 3 in median peripheral zone. Risk of overdiagnosis of non significant prostate cancer ? Preoperative criteria of non significant prostate cancer - T1c - PSA < 10ng/ml - Gleason score 6 or less - A single positive biopsy with less than 3mm of cancer [Terris 2003] GOAL OF THE STUDY To assess the risk of non significant prostate cancer on one positive needle prostate biopsy Gleason 6, PSA < 10ng/ml and less than 3 mm of cancer Abstract Introduction Methods Conclusion  Selection using biopsy parameters (T1c, PSA<10, Gleason=<6, 1 positive biopsy and less than 3mm of cancer) underestimates the risk of non significant prostate cancer  Even with 21 biopsies, more than two third of patients had a significant prostate cancer 819 patients included in our prospective clinical database of radical prostatectomy 239 patients diagnosed by using an extended 21-sample needle biopsy protocol Mean age: 62 years Mean serum PSA 6.3ng/ml (2.6-9.9) Prostate volume 61.4cc (34-110) Evaluation of significant prostate cancer: pT3, Gleason>=7, prostate cancer volume >0.5cc Results according to the number of biopsies 1+ out of 6 biopsies (sextant) n= 23 patients But: 29 patients were missed by this selection because of additional positive biopsies 1+ out of 12 PZ biopsies (sextant + far lateral PZ biopsies) n= 24 patients 9 patients were missed by this selection because of additional positive biopsies 1+ out of 12 PZ biopsies + 6 TZ biopsies n= 24 patients 1 patient was missed by this selection because of additional positive biopsies) 1+ out of 21 n= 16 patients Mean Gleason score: 6,5 (6 cancer with Gleason 7 and 1 with Gleason 8) Stage: 1 pT0, 3 pT2a, 6 pT2c, 5 pT3a, 1 pT3b Results Transrectal ultrasound-guided sextant biopsies (Hodge 1989) Gold standard Minimizing morbidity Detection of clinically insignificant cancer Maximizing the detection of large tumors However, Sensitivity may be suboptimal, especially for larger and eccentrically shaped prostates False-negative rates: between 13% to 41% on repeat biopsy Increasing the number of biopsies? In the transitional zone Modifying the angle of the needle to target the peripheral zone more efficiently Use of these approaches = increasing the detection rate from 20.4% to 41% Tumor Volume >0.5cc pT3 >0.5cc or Gleason>7 1 / 6 (n=23) 10 (43%) 12 (52%) 1 / 12 (n=24) 8 (33%) 14 (58%) 1 / 18 (n=24) 12 (50%) 16 (66%) 1 / 21 (n=16) 5 (33%) 7 (44%) Significant cancer diagnosed or non diagnosed due to the selection pT3, Gleason>7 and/or PC volume >0.5cc Non diagnosed PC with % of signficiant PC 1 / 6 (n=23) 12 (52%) 29 pts with 62% 1 / 12 (n=24) 14 (58%) 9 pts with 55% 1 / 18 (n=24) 16 (66%) 0 pt 1 / 21 (n=16) 7 (44%) >0.5cc pT3 >0.5cc or Gleason>7 1 / 6 (n=17) 5 (29%) 11 (64%) 1 / 12 (n=14) 3 (21%) 7 (50%) 1 / 18 (n=15) 3 (20%) 7 (46%) 1 / 24 (n=7) 2 (28%) 4 (57%) Only patients with first positive procedure