The optimal dosing selleck regimen was cetrorelix acetate, 60 mg, administered at 26-week intervals. The improvement in IPSS and peak flow rate over placebo observed throughout the duration of the study was comparable with that observed with α-blockade. At the effective doses, cetrorelix did not appear to cause vasomotor or sexual side effects and lowered testosterone levels only transiently. Despite the fact that testosterone Inhibitors,research,lifescience,medical levels had returned to baseline within a few weeks, effectiveness continued for the 26 weeks in between the dosing of the drug. Due to the above findings, phase III studies

were conducted in the United States and Europe; in the US study, 637 men were randomized to receive either two doses of placebo or cetrorelix on weeks 2 and 26.37 Upon conclusion of the trial, the drug showed no statistically significant benefit in improving IPSS. In addition, the drug did not have a significant effect on peak flow rate or prostate volume versus placebo. It is difficult to reconcile this lack of efficacy given favorable prior Inhibitors,research,lifescience,medical results. A Inhibitors,research,lifescience,medical subsequent multicenter European trial also failed to show any treatment-related efficacy of cetrorelix.38 The experience with cetrorelix highlights the importance

of randomized, placebo-controlled trials that are appropriately powered to show clinical benefit and safety. NX-1207 NX-1207 is a new drug under investigation for the treatment of symptomatic BPH. NX-1207 has been suggested to elicit a proapoptotic effect on the prostate.39 The drug is injected directly into the prostate as a single administration. Four clinical trials yet to be published in the peer-reviewed literature have been interpreted to show improvement Inhibitors,research,lifescience,medical in LUTS exceeding that of all other medical therapies currently marketed for the treatment of BPH. NX-1207 was also reported to decrease prostate volume and increase Qmax. These clinical benefits were maintained after angle injection for a year. Phase III studies are underway to define the true efficacy, safety, and mechanism of action of this novel

approach to Inhibitors,research,lifescience,medical treating BPH. Combination Therapy α-Blocker and 5-ARI The VA Cooperative Trial11 and the PREDICT trial13 unequivocally demonstrated there is no observed benefit of adding a 5-ARI to an α-blocker to further decrease LUTS or increase peak urinary flow rate during the first year of treatment in unselected men with clinical BPH. The MTOPS trial asked an entirely different GSK-3 clinical question than the VA Cooperative and PREDICT trials. MTOPS was the first study to examine the ability of medical therapy to prevent disease progression in a group of men with clinical BPH independent of prostate volume.14 BPH progression was defined by a 4-point increase in IPSS, development of AUR, renal insufficiency, UTI/urosepsis, or social incontinence. The need to undergo BPH surgery was not a primary endpoint, but this clinical information was captured.