IntroductionHistorically, medical therapy of BPH has had its foundations in alpha-blockers in monotherapy or in combination with 5 alpha reductase inhibitors (5-ARIs); in particular, two important trials (COMBAT and MTOPS) have demonstrated the pivotal role of combination therapy instead of monotherapy and have individuated which patients are most likely to benefit from alpha-blockers, 5-ARIs, or their combination. However different side effects of these drugs, such erectile dysfunction, ejaculatory disorders, loss of libido, could affect the adherence to treatment. In fact, SeR-Se-Ly would work by blocking 5-alpha reductase and the binding between the dihydrotestosterone and the androgen receptor, antagonizing the a1-adrenergic receptor, and preventing cell proliferation and the production of COX-2 and 5-leukotrienes. Prior randomized controlled trials confirmed the use of alpha-blockers in conjunction with Lipidic Extract (LE) of Serenoa Repens (SeR), specifically compounds containing both Selenium (Se) and Lycopene (Ly). Based on these premises, the aim of this Italian multicenter case-control prospective non-randomized study is to compare the therapy with SeR-Se-Ly alone versus Dutasteride alone against BPH, in order to research a good therapeutic alternative with limited side effects.Materials and methodsFrom April 2021 to April 2022, 269 consecutive patients from 21 Italian centers were enrolled in this case-control study. The inclusion criteria were: age between 55 and 80 years old, digital rectal examination negative for prostate nodules, PSA<12, prostate volume >40 cc (assessed by ultrasound), Qmax <