Articles

The Relationship between Prostate Inflammation and Lower Urinary Tract Symptoms: Examination of Baseline Data from the REDUCE Trial eulogo1

By: J. Curtis Nickela lowast , Claus G. Roehrbornb, Michael P. O’Learyc, David G. Bostwickd, Matthew C. Somervillee and Roger S. Rittmasterf

Published online: 01 December 2008

Keywords: Prostatitis, Inflammation, Benign prostatic hyperplasia, Lower urinary tract symptoms

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Abstract

Objective

The ongoing REDUCE trial is a 4-yr, phase 3, placebo-controlled study to determine if daily dutasteride 0.5mg 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 ≥2.5ng/ml and ≤10ng/ml (50–60 yr), or ≥3.0ng/ml and ≤10ng/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 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.

Conclusions

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 and LUTS may have limited the strength of this relationship. The impact of baseline prostate inflammation on progression of LUTS and/or associated complications will be determined during 4-yr longitudinal follow-up.

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.

Keywords: Prostatitis, Inflammation, Benign prostatic hyperplasia, Lower urinary tract symptoms.

Footnotes

a Department of Urology, Queen's University, Kingston General Hospital, Kingston, ON, Canada

b Department of Urology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA

c Department of Surgery, Harvard Medical School, Division of Urology, Brigham and Women's Hospital, Boston, MA, USA

d Bostwick Laboratories, Glen Allen, VA, USA

e GlaxoSmithKline, Biostatistics, Research Triangle Park, NC, USA

f GlaxoSmithKline, Urology Clinical Development and Medical Affairs, Research Triangle Park, NC, USA

lowast Corresponding author. Kingston General Hospital, Kingston, Ontario, Canada K7L 2V7. Tel. +1 613 548 2497; Fax: +1 613 545 1970.

z.star Presented at the 22nd Annual EAU Congress, Berlin, Germany, March, 2007.

z.starz.star Please visit www.eu-acme.org/europeanurology to read and answer questions on-line. The EU-ACME credits will then be attributed automatically.