Arnhem, 13 November 2008 -- In the December issue of European Urology (http://www.elsevier.com/locate/eururo) Dr. Curtis Nickel and associates report on the evidence of a relationship between prostate inflammation and lower urinary tract symptoms (LUTS) in men enrolled in the REDUCE trial.
The REDUCE (Reduction by DUtasteride of prostate Cancer Events) trial is a 4-year, phase-III placebo-controlled study that evaluates whether the drug dutasteride decreases the risk of biopsy-detectable prostate cancer. Dutasteride is a 5-alpha-reductase inhibitor, a drug that inhibits the conversion of testosterone into dihydrotestosterone (DHT), a hormone that may cause benign prostatic obstruction. The trial involves men with a negative prostate biopsy. The men were given either dutasteride or a placebo and followed for 4 years.
According to Dr Curtis Nickel, the lead researcher in the trial: "The data from the entrance biopsy have enabled additional investigations to be made, including examination of the relationship between prostate inflammation and LUTS."
The study is remarkable for its scope, which includes data on 8,224 men. A majority of participants had chronic inflammation at baseline. Total IPSS (International Prostate Symptom Score; the most widely used gauge of lower urinary tract symptoms associated with an enlarging prostate) and subscores were higher in the group of patients with chronic inflammation at baseline compared to those with no chronic inflammation. The differences were small but statistically significant. A regression analysis was performed. It revealed that higher values of age and average chronic inflammation were significantly associated with higher IPSS scores.
According to Dr Nickel, "The study entry criteria that selected older men and decreased enrollment of men with a greater degree of inflammation and LUTS may have limited the strength of the relationship between the degree of chronic inflammation and LUTS. It may actually be stronger."
The impact of baseline prostate inflammation on the progression of LUTS and/or associated complications will be determined during a 4-year follow-up study.
Notes to Editors:
The article "The relationship between prostate inflammation and lower urinary tract symptoms: examination of baseline data from the REDUCE trial," by J. Curtis Nickel, Claus G. Roehrborn, Michael P. O'Leary, David G. Bostwick, Matthew C. Somerville, and Roger S. Rittmaster, is published in European Urology, December 2008 (Vol. 54, Issue 6, Pages 1379-1384), doi:10.1016/j.eururo.2007.11.026. Copies for members of the media are available by contacting the Elsevier press office, newsroom@elsevier.com
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European Urology