Confirmatory biopsies could identify parameters of potential aggressiveness that have been missed on initial biopsies (IB) such as higher Gleason grade or greater tumor volume. Additionally, centralized pathological review is often not utilized. This study evaluated the impact of early CB, together with a centralized pathological review. It was a multicenter prospective study initiated in 200. Inclusion criteria included: age 75 years or less, stage T1c or T2a, Gleason 6 or less, PSA <10ng/ml, 2 (out of 12) or fewer biopsy cores with CaP, and each cancer foci 3 mm or less. CB (at least 16 cores) was performed 3 months or less after IB. CBs were examined by the local pathologist and were reassessed by a centralized pathological review. Patients in whom CB did not meet the criteria used in IB for selection were excluded from the study and offered active treatment.
155 patients with median age 64 and median PSA 5.7ng/ml were initially eligible for AS. The CB before centralized review identified 99 patients still meeting eligibility criteria, including 53 cases without cancer, and 46 cases with 1 or 2 positive biopsies. The 56 remaining patients were excluded due to Gleason 7 (3+4) in 18 patients, >2 positive biopsies in 37 men, or cancer foci >3 mm. Among these 56 patients, 37 (66%) had more than one exclusion criteria. Following CB centralized pathological review, Gleason score was upgraded in 8 cases from 6 to 7 (3+4), and cancer micro-foci that had been missed were identified in 5 cases. Eventually, 5 patients that were initially eligible on CB before review were excluded from the study following a Gleason 7 grading (n=3) or additional cancer foci (n=2). Thus, these methods resulted in a treatment plan alteration if 5% of initially selected patients for AS.
Presented by Gaelle Fromont, et al. at the American Urological Association (AUA) Annual Meeting - May 14 - 19, 2011 - Walter E. Washington Convention Center, Washington, DC USA
Reported for UroToday by Christopher P. Evans, MD, FACS, Professor and Chairman, Department of Urology, University of California, Davis, School of Medicine.