The predictability of T3 disease in staging MRI following prostate biopsy decreases in patients with high initial PSA and Gleason score.

To obtain improved accuracy in predicting extracapsular extension (ECE) and seminal vesicle invasion (SVI), we evaluated the variables affecting the predictability of staging magnetic resonance imaging (MRI, phased-array coil) and estimated their impact on accuracy between preoperative MRI staging and histological outcome. A total of 121 patients with localized or locally advanced prostate cancer who underwent robotic radical prostatectomy (RALP) were included. Following transrectal biopsy, all enrolled patients had undergone MRI for staging work-up. After RALP, only 43.8% (53/121) of the patients were matched with the MRI predicted stage. Compared to the matched group in the prediction of ECE, the unmatched group had significantly higher initial prostate-specific antigen (PSA, 12.8 ng ml⁻¹ versus 8.1 ng ml⁻¹, P = 0.048). In the prediction of SVI, initial PSA (8.1 ng ml⁻¹ versus 17.3 ng ml⁻¹, P = 0.009) and biopsy Gleason score (6.5 versus 7.6, P = 0.035) were significantly higher in the unmatched group. When applying clinical cutoffs of initial PSA of 10 and 20 ng ml⁻¹, the accuracy of MRI in the prediction of ECE was decreased in the group with PSA over 20 ng ml⁻¹ (75.6, 64.5 and 37.5%, P = 0.01), and this group had significantly decreased accuracy of MRI in the prediction of SVI (91.5, 77.4 and 37.5%, P<0.01). Applying the clinical cutoff of a Gleason score of 7, the accuracy of MRI in the prediction of SVI was decreased in the higher Gleason score group (93.9, 82.1 and 62.9%, P = 0.01). Thus, for these patient groups, to obtain margin negativity during radical prostatectomy, operative findings, rather than post-biopsy MRI images, may provide substantial information, implying a clinical advantage in conducting MRI before prostate biopsy.

Efficacy, Safety and Tolerability of Fesoterodine in Asian Patients with Overactive Bladder.

OBJECTIVES: To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg once daily (QD) compared with placebo in Asian subjects with overactive bladder (OAB) after 12 weeks of treatment. METHODS: This phase II, dose-finding study consisted of a 2-week placebo run-in period followed by a 12-week, randomized, double-blind, placebo-controlled, treatment period. Eligible subjects were aged ≥20 years with ≥8 micturitions per 24 h and ≥1 urgency urinary incontinence (UUI) episodes per 24 h reported in a 3-day diary. The subjects were randomized to receive placebo, fesoterodine 4 mg, or fesoterodine 8 mg QD for 12 weeks. RESULTS: Of 1232 subjects who entered the placebo run-in period, 951 received double-blind treatment. The mean number of UUI episodes per 24 h at baseline was 2.2 among the three treatment groups. The two fesoterodine groups showed statistically significant decreases from baseline in the mean number of UUI episodes per 24 h at week 12 (primary endpoint) compared with placebo. Most all-causality adverse events (e.g. dry mouth and constipation) were mild or moderate. The percentage of subjects with severe adverse events was low and similar among the treatment groups (placebo, 1.3%; fesoterodine 4 mg, 1.9%; fesoterodine 8 mg, 1.0%). CONCLUSION: Fesoterodine 4 and 8 mg QD were significantly better than placebo in improving OAB symptoms. Overall, the two fesoterodine dosing regimens were well tolerated. These results suggest that fesoterodine 4 and 8 mg QD are effective and well-tolerated treatments for OAB in Asian subjects.