Prostatic Diseases and Male Voiding Dysfunction Preliminary Assessment of Safety and Efficacy in Proof-of-Concept, Randomized Clinical Trial of Tanezumab for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Overall, 62 patients were randomized (30 to tanezumab and 32 to placebo). At week 6, tanezumab marginally improved the average daily pain (least-squares mean difference from placebo 0.47, 90% confidence interval 1.150-0.209) and urgency episode frequency (leastsquares mean difference from placebo 1.37, 90% confidence interval 3.146-0.401). No difference was seen in the National Institutes of Health chronic prostatitis symptom index total score or micturition frequency at week 6. The most common adverse events were paresthesia and arthralgia. The odds of having a 30% reduction in pain were 1.75-fold greater (90% confidence interval 0.65-4.69) for patients receiving tanezumab versus placebo. CONCLUSION Tanezumab might improve symptoms for some patients with chronic prostatitis/chronic pelvic pain syndrome. Although proof of concept was not demonstrated in the present study, additional studies with larger populations and stricter inclusion criteria according to patient phenotype might identify populations in which antinerve growth factor treatment will provide clinical benefit. UROLOGY 80: 1105‐1110, 2012. © 2012 Elsevier Inc.