Some patients with low volume Gleason 6 CaP actually harbor either Gleason score or higher volume disease. A second confirmatory biopsy (CB) after the diagnosis biopsy can help to identify these patients and eliminate their enrollment in an AS protocol. This study evaluated the impact of a CB in addition to centralized pathological review. They performed a multicenter prospective study in 2008 to identify patients eligible for AS with the following criteria: age 75 years or less, CaP clinical stage T1c or T2a, Gleason 6 or less, PSA less than 10 ng/ml, ≤2 (out of 12) biopsy cores with CaP, and each cancer foci 3 mm or less. Patients enrolled in the trial that undergo 10-year follow-up. CB (at least 16 cores) was performed 3 months or less after diagnostic biopsy. 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 the diagnostic biopsy for selection were excluded from the study and an immediate active treatment was proposed.
A total of 155 patients (median age 64 and median PSA 5.7 ng/ml) were initially eligible for AS. The CB before centralized review identified 99 patients who still met the eligibility criteria, including 53 cases without cancer on the CB, and 46 cases with 1 or 2 positive biopsies. The 56 remaining patients were excluded because of the following characteristics: Gleason 7 (3+4) in 18 patients, more than 2 positive biopsies in 37 patients, or cancer foci more than 3 mm in 50 patients. Among these 56 patients, 37 (66%) had more than 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. Five 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). He concluded that up to one third of the initially selected patients for AS were reclassified as potentially more aggressive and centralized pathological review of the CB modified the therapeutic strategy in 5% of the initially selected patients.
Presented by Gaelle Fromont, MD, PhD, et al. at the 26th Annual European Association of Urology (EAU) Congress - March 18 - 21, 2011 - Austria Centre Vienna, Vienna, Austria
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