Serenoa Repens–Lycopene–Selenium and Epilobium–Palmitoylethanolamide–Calendula after transperineal prostate biopsy: a tertiary single center experience

Introduction: Transperineal prostate biopsy (TPBx) is the gold standard for the diagnosis of prostate cancer, although it may transiently worsen lower urinary tract symptoms (LUTS). Preventive medical strategies for post-biopsy LUTS are lacking. Phytotherapeutic compounds have demonstrated benefits in LUTS management, but their effectiveness in mitigating urinary and sexual dysfunction following TPBx remains unexplored. Materials and methods: This retrospective analysis included 623 patients who underwent TPBx (November 2023-July 2025) at San Raffaele Hospital, Milan, Italy. Following TPBx, patients either received Serenoa Repens, Lycopene and Selenium (Profluss®) with or without Epilobium-Palmitoylethanolamide-Calendula (Riflog CM®) (i.e. treatment group), or no post-biopsy treatment (control group). LUTS and erectile function (EF) were assessed using the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF) at baseline, 1 week, and 1 month after TPBx, respectively. Subgroup analyses were conducted according to baseline IPSS and IIEF severity, and logistic regression models evaluated the association between treatment exposure and LUTS worsening or EF recovery within each IPSS and IIEF category. Results: Median PSA and prostate volume were comparable between treatment and control groups. The overall prostate cancer detection was 57%, while clinically significant cancer (ISUP ≥ 2) was detected in 43% of patients. There were 202 (32%) patients with mild IPSS, 341 (55%), with moderate IPSS, and 80 (13%) with severe IPSS at baseline. No differences in baseline IPSS were detected among treatment vs. control groups [12 (IQR: 7–17) vs. 11 (IQR: 7–16), respectively]. Treatment discontinuation at 1 month was higher in patients with moderate/severe LUTS compared to mild LUTS (49–51% vs. 34%, p < 0.001), whereas no significant differences in treatment discontinuation were observed among IIEF categories. Logistic regression analysis showed that the phytotherapeutic combination significantly reduced the risk of IPSS worsening at 1 week in patients with mild LUTS (OR 0.23, 95%CI: 0.10–0.54, p = 0.01), with no effect on IIEF recovery. Conclusion: Patients with mild pre-biopsy LUTS treated with post-biopsy phytotherapeutic combination showed reduced odds of short-term IPSS increase at 1-week after biopsy compared to untreated patients. These results are hypothesis-generating and prospective randomized trials are needed to confirm these findings.