Benign Prostatic Hyperplasia (BPH) is a result of prostate inflammation, frequently occurring in metabolic syndrome (MetS). Low testosterone is common in MetS. A randomized clinical trial was designed to evaluate if 24 weeks of testosterone therapy (TTh) in BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation.
One-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled. They were categorized into normal testosterone (TT ≥ 12 nmol/L and cFT ≥ 225 pmol/L; n = 48) and testosterone deficient (TD) (TT < 12 nmol/L and/or cFT < 225 pmol/L; n = 72) then randomized to testosterone gel 2% (5 g/daily) or placebo for 24 weeks. At baseline and follow-up, questionnaires for urinary symptoms and trans-rectal ultrasound were performed. Prostate tissue was collected for molecular and histopathological analyses.
No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]). In TD + TTh, increase in prostate but not adenoma volume was observed (2.64 mL [0.07; 5.20] and 1.82 mL [- 0.46; 0.41], respectively). Ultrasound markers of inflammation were improved. In a subset of 61 men, a hyper-expression of several pro-inflammatory genes was found in TD + placebo when compared with normal testosterone. TTh was able to counteract this effect. For 80 men, the inflammatory infiltrate was higher in TD + placebo than in normal testosterone (0.8 points [0.2; 1.4]) and TD + TTh men (0.9 points [0.2; 1.5]).
Twenty-four weeks of TTh in TD men with BPH and MetS improves ultrasound, molecular and histological proxies of prostate inflammation. This does not result in symptom improvement.
Journal of endocrinological investigation. 2022 Mar 17 [Epub ahead of print]
G Rastrelli, S Cipriani, F Lotti, I Cellai, P Comeglio, S Filippi, V Boddi, P A Della Camera, R Santi, L Boni, G Nesi, S Serni, M Gacci, M Maggi, L Vignozzi
Department of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy., Interdepartmental Laboratory of Functional and Cellular Pharmacology of Reproduction, Department of Neuroscience, Psychology, Pharmacology and Child Health, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy., Urology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy., Pathological Anatomy Unit, Careggi University Hospital, Largo Piero Palagi, 1, 50139, Florence, Italy., Unit of Clinical Epidemiology, IRCCS Policlinico San Martino, Largo Rosanna Benzi, 10, 16132, Genoa, Italy., Department of Health Sciences, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy., Department of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy. .