Prostate health supporting by a novel nutraceutical compound with antioxidant property: Results from a pilot study

In recent years, healthcare strategies have increasingly emphasized a holistic and comprehensive approach in patient management that extends beyond the treatment of isolated physical symptoms. In this context, the use of nutraceuticals has gained interest as a complementary approach, particularly in managing chronic conditions and age-related disorders, such as lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH). A new dietary supplement, contains a blend of bio-active compounds (Drolessano^®)-including lycopene, sulforaphane, silymarin, glutathione, escine, tryptophan, and green tea extract-has been introduced in Italian pharmacopeia as food supplements in urological and andrological diseases. Here, we aim to assess the effects of Drolessano^® on serum prostate-specific antigen (PSA) levels and urinary symptoms in individuals with BPH. Fifty-five men presenting with elevated PSA values and mild lower urinary tract symptoms (International Prostate Symptom Score [IPSS] < 7) were recruited in this pilot study. All enrolled patients underwent Drolessano^® one tablet daily for 6 months. PSA concentrations and IPSS scores were recorded at baseline (T0), at 3 months (T1), and at the end of the treatment period (T2). Data at the follow-up has been compared with those at baseline. Patients enrolled experienced a statistical significance average PSA declined from 4.8 to 3.7 ng/mL (<i>p</i> < 0.003), as well as in improvement of quality of life, tested by patient reported outcomes. The supplement was generally well tolerated, and no serious adverse effects were reported during the study period. These preliminary data suggest that Drolessano^® may offer a supportive benefit in the management of BPH, particularly with respect to reducing PSA levels and improvement quality of life. Otherwise, controlled trials with larger sample sizes are needed to substantiate these findings and to better understand the underlying mechanisms of action.