A randomized placebo‐controlled multicentre study to evaluate the safety and efficacy of finasteride for male chronic pelvic pain syndrome (category IIIA chronic nonbacterial prostatitis)

Abstract

OBJECTIVE To determine if finasteride can reduce symptoms in men with a clinical diagnosis of chronic nonbacterial prostatitis (National Institutes of Health, NIH, category IIIA chronic pelvic pain syndrome, CPPS) compared with placebo. PATIENTS AND METHODS Men (76) with category IIIA CPPS enrolled in four North American prostatitis research centres were randomized after a 2‐week placebo run‐in to finasteride or placebo for 6 months. The primary efficacy variable was a subjective overall assessment (SOA); the secondary efficacy variables included the NIH chronic prostatitis symptom index (NIH‐CPSI) and safety data. Patients were assessed at screening, baseline (after the 2‐week placebo run‐in), 3 and 6 months. RESULTS Sixty‐four patients had at least one assessment on medication (31 placebo, 33 finasteride); 75% of the finasteride and 54% of the placebo group had at least a mild improvement (defined as > 25% improvement in SOA), and 44% and 27%, respectively, a moderate or marked improvement (>50% improvement in SOA). The trend was similar in the NIH‐CPSI scores. Five patients in the finasteride and seven in the placebo group reported medication‐related adverse events. CONCLUSION This randomized placebo‐controlled pilot study suggests that finasteride was of benefit for some men with category IIIA CPPS, but the results do not justify recommending finasteride as monotherapy, except for men who also have benign prostatic hyperplasia. A larger, properly powered study, possibly evaluating combination with other therapies or specifically in men with prostatitis and benign prostatic hyperplasia, is required to confirm any clinical benefit.

Metabolic syndrome and lower urinary tract symptoms: the role of inflammation

“…34 However, 5a-reductase inhibitors can induce a regression of prostatic glandular tissue, the specific area where the prostatic inflammation is located, that can lead to a regression of prostatic inflammation. 35 In our study we adjusted the correlations between MetS and IS for the use of 5a-reductase inhibitors to avoid this potential bias.…”

Experimental rodent models of prostatitis: limitations and potential

“…Although it was not clear whether the dorso-lateral prostate was involved or not this model demonstrated two distinct histological phases of bacterial inflammation in the ventral prostate. 73 During the initial acute infection stage (days [1][2][3][4][5][6][7][8][9][10][11][12][13][14] an acute response to the bacterial challenge with florid infiltration of polymorphonuclear cells into bacteria-containing spaces was observed. 74 As the infections became chronic, heavy lymphocyte infiltration and fibrous tissue proliferation completely engulfed the ventral prostatic lobe.…”

“…10,12,13 The remaining 60-95% cases of clinical prostatitis (categories IIIA and IIIB) may involve (i) hormonal imbalance; 14,15 (ii) neurological dysfunction; 16,17 (iii) a-adrenergic system abnormalities; [18][19][20] (iv) urinary reflux into the prostate; [21][22][23] (v) inappropriate cytokine release [24][25][26][27][28][29][30][31][32] and/or (vi) an autoimmune response. [33][34][35][36][37] The patients typically have repeat episodes of prostatitis and therapy is 'hit or miss'.…”

Treatment of chronic prostatitis/chronic pelvic pain syndrome

“…Finasteride has been shown in small, poorly controlled trials to have a possible effect in CP/ CPPS, but a small, randomised, placebo-controlled study did not suggest significant efficacy as monotherapy [18]. Whilst twice as many patients responded to 6 months of finasteride compared with placebo, the actual magnitude of improvement did not reach statistical significance.…”