BPH treatment arrests prostate growth, improves symptoms

November 1, 2007

Treatment with an investigational agent known as elocalcitol effectively arrested prostate growth in BPH patients, according to Italian researchers. The therapy also showed improvements in urgency, frequency, and nocturia.

Treatment with an investigational agent known as elocalcitol effectively arrested prostate growth in BPH patients, according to Italian researchers. The therapy also showed improvements in urgency, frequency, and nocturia.

“Elocalcitol acts on key factors in BPH progression and may represent a valid monotherapy alternative to the combination currently recommended by the American and European urology associations,” said Walter Artibani, MD, of the University Hospital of Padua, Italy.

The double-blind, randomized, placebo-controlled, parallel group design trial, carried out on a total of 514 patients with BPH at 46 centres in Italy and Germany, was intended to determine the effect of elocalcitol monotherapy (75 or 150 mcg), as well as a combination of elocalcitol (150 mcg) with tamsulosin (Flomax), 0.4 mg, on prostate volume as well as on symptoms.

The primary endpoint of the study was met with high statistical significance, according to the authors. Among the total intent-to-treat population, mean change in prostate volume after 24 weeks was +0.41% in patients receiving 150 mcg of elocalcitol, compared with +2.55% in patients receiving placebo (p<.0002). Comparable results were found in the combination protocol population.

The authors also noted a statistically significant effect on the number of episodes per day in both the group receiving elocalcitol, 150 mcg (–3.12, p<.0108) and the combination group (–2.83, p<.0386) group, compared with placebo (–1.82), in subgroups of patients with three or more urgency episodes per day at baseline.