Objective-The ongoing REDUCE trial is a 4-yr, phase 3, placebo-controlled study to determine if daily dutasteride 0.5 mg reduces the risk of biopsy detectable prostate cancer. Prostate biopsies performed in all men prior to entry were centrally reviewed, thus allowing an examination of the relationship between inflammatory changes and lower urinary tract symptoms (LUTS).Methods-Eligible men were aged 50-75 yr, with serum prostate-specific antigen ≥2.5 ng/ml and ≤10 ng/ml (50-60 yr), or ≥3.0 ng/ml and ≤10 ng/ml (>60 yr) and an International Prostate Symptom Score (IPSS) <25 (or <20 if already on alpha-blocker therapy). Acute prostatitis was an exclusion criterion. For a given individual, inflammation was assessed across all cores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3). LUTS was assessed with the use of the IPSS. The relationship between inflammation scores (averaged over all cores) and total IPSS; grouped IPSS (0-3, 4-7, 8-11, 12-15, 16-19, ≥20); and irritative, obstructive, and nocturia subscores was determined by Spearman rank correlations. The relative contribution of inflammation, age, and body mass index was then examined with the use of linear regression analyses.Results-Data were available for 8224 men. Statistically significant but relatively weak correlations were found between average and maximum chronic inflammation and IPSS variables (correlation coefficients, 0.057 and 0.036, respectively; p < 0.001 for total IPSS). Both age and *Corresponding author. J. Curtis Nickel, Professor of Urology, Kingston General Hospital, Kingston, Ontario, Canada K7L 2V7. Tel. 613-548-2497; Fax: 613-545-1970. E-mail address: jcn@queensu.ca (J.C. Nickel). Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.Presented at the 22nd Annual EAU Congress, Berlin, Germany, March, 2007 Take-home message Central review of initial prostate biopsies performed in men enrolled into the REDUCE trial allowed examination of the relationship between inflammation and lower urinary tract symptoms (LUTS). In this population, there was a relationship between LUTS and chronic inflammation. average chronic inflammation were significant in the linear regression after adjustment for other covariates; for both variables, more severe inflammation was associated with higher IPSS scores.
NIH Public AccessConclusions-In the REDUCE population, there is evidence of a relationship between the degree of LUTS and the degree of chronic inflammation. Study entry criteria that selected older men and decreased enrolment of men with a greater degree of inflammation ...