dutasteride and Chronic-Disease

To evaluate whether the presence of basal cell hyperplasia (BCH) in negative biopsies is associated with concurrent lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH), clinical prostatitis, and future prostate cancer (PCa) in repeat prostate biopsy.. We performed a retrospective analysis of 6471 men, 50-75 years old with prostate-specific antigen between 2.5 and 10 ng/ml and prior negative biopsy who were enrolled in the Reduction by Dutasteride of PCa Events trial and underwent a 2-year repeat biopsy. The association between baseline BCH and risk of PCa, BPH/LUTS and clinical prostatitis measured at baseline were evaluated with logistic regression in uni/multivariable analysis, controlling for baseline patient characteristics.. Among 6471 men enrolled, 84 (1.3%) had BCH in the baseline prostate biopsy. BCH was associated less chronic inflammation and more prostate atrophy (P < 0.05) and was unrelated to baseline patient characteristics. In both uni/multivariable analyses, BCH was not associated with PCa in repeat biopsy (univariable odds ratio [OR] = 0.98, 95% confidence interval [CI] = 0.53-1.82, P > 0.05; multivariable OR=1.15, 95% CI = 0.61-2.16, P > 0.05), BPH/LUTS (univariable OR = 1.13, 95% CI = 0.71-1.81, P > 0.05; multivariable OR = 1.20, 95% CI = 0.74-1.94, P > 0.05), or clinical prostatitis (univariable OR = 0.56, 95% CI = 0.18-1.81, P > 0.05; multivariable OR = 0.57, 95% CI = 0.18-1.83, P > 0.05).. Among men undergoing repeat prostate biopsy with a baseline negative biopsy, BCH was associated with more histological atrophy and less chronic prostatitis, but was unrelated to LUTS/BPH, clinical prostatitis or future PCa risk.

Topics: 5-alpha Reductase Inhibitors; Administration, Oral; Aged; Biopsy; Chronic Disease; Diagnosis, Differential; Dose-Response Relationship, Drug; Dutasteride; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prognosis; Prostate; Prostatic Hyperplasia; Prostatic Neoplasms; Prostatitis; Retrospective Studies

Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population.. REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis.. Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6%) had prostatitis-like pain and 427 (7.9%) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49% vs 37%, respectively, p = 0.0033) and prostatitis-like syndrome (46% vs 35%, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6%) than to dutasteride (2.5%, p = 0.003).. Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen.

Topics: 5-alpha Reductase Inhibitors; Aged; Azasteroids; Chronic Disease; Double-Blind Method; Dutasteride; Humans; Male; Middle Aged; Pain Measurement; Prostatitis

Symptoms of abacterial chronic prostatitis/chronic pelvic pain syndrome are considered to be associated with prostate inflammation. The ongoing Reduction by Dutasteride of Prostate Cancer Events trial is a 4-year, phase III, placebo controlled study to determine whether 0.5 mg dutasteride daily decreases the risk of biopsy detectable prostate cancer. All men underwent biopsy before study entry, allowing review of the relationship between histological prostate inflammation and prostatitis symptoms.. Eligible men were 50 to 75 years old with serum prostate specific antigen 2.5 ng/ml or greater and 10 ng/ml or less (ages 50 to 60 years), or 3.0 ng/ml or greater and 10 ng/ml or less (older than 60 years), and an International Prostate Symptom Score of less than 25 (or less than 20 if already on alpha-blocker therapy). Acute prostatitis was an exclusion criterion. The National Institutes of Health Chronic Prostatitis Symptom Index was used to assess prostatitis-like symptoms. Spearman rank correlations were used to assess the relationship between acute and chronic inflammation, and Chronic Prostatitis Symptom Index scores for the pain, urinary symptoms and quality of life domains as well as average pain, total score and prostatitis-like symptoms.. Data were available on 5,597 patients. The distribution of inflammation status was similar for those with and without chronic prostatitis-like symptoms. Significant correlations were found between average chronic inflammation, and total Chronic Prostatitis Symptom Index score and subscores for urinary symptoms and quality of life but the magnitude of these correlations was small.. A lack of clinically meaningful association was found between prostatitis-like pain symptoms and histological inflammation in the Reduction by Dutasteride of Prostate Cancer Events population, suggesting that the view that symptoms of chronic prostatitis/chronic pelvic pain syndrome and prostate inflammation are associated needs further scrutiny.

Topics: 3-Oxo-5-alpha-Steroid 4-Dehydrogenase; Aged; Azasteroids; Biopsy, Needle; Chronic Disease; Dutasteride; Enzyme Inhibitors; Humans; Inflammation; Male; Middle Aged; Pelvic Pain; Prostate; Prostatic Neoplasms; Prostatitis; Randomized Controlled Trials as Topic