ESTRO 2025 - Abstract Book

S1937

Clinical - Urology

ESTRO 2025

Purpose/Objective: The primary objective was to determine whether the addition of a phytotherapic and pre-probiotic dietary supplement (DS) with peppermint extract, caraway extract, fennel extract, activated charcoal, chamomile extract, Bacillus coagulans Saccharomyces boulardii, vitamin B2, B6, B1, B12 ( EPAPLUS Digestcare) may help on reducing the need for rectal probes or laxatives in patients with prostate cancer (PC) undergoing radiotherapy (RT) to reach optimal rectal volumes. Secondary objectives were upper and lower flatulence discomfort, functional constipation, stool characteristics, and finally, assessing the safety of the DS, survival and biochemical recurrence. Material/Methods: We performed a prospective, randomized, open study, from November 2021 to May 2022. It was approved by local Ethical Committee. 56 PC patients undergoing RT were randomized into an experimental group (nutritional advice + DS) and a control group (nutritional advice). Patients answered validated surveys about upper and lower flatulence (GSRS scale), functional constipation (ROMA IV scale), and stool characteristics (Bristol scale) before starting and after completing radiotherapy treatment. In November 2024, the medical records of the patients were updated to determine GI CTCAE v5 symptoms, recurrence and survival data. Results: From the 56 patients included in the study, 30 were assigned to the experimental group and 26 to the control group. Mean age was 73. There were no baseline differences between groups in the Bristol (p=0.69), and ROMA IV (p=0.56) scales before starting RT. However baseline differences were observed in upper (p=0.027) and lower (p=0.024) flatulence GSRS scale, with higher levels in the experimental group, which may indicate a selection bias. After finishing RT, there were no significant differences between groups in the need for rectal probes (p=0.296), laxatives (p=0.459), or enemas (p=0.414). No differences were observed in constipation (p=0.607), Bristol (p=0.627), or lower (p=0.652) and upper (p=0.361) flatulence GSRS scales. 60% of the patients reported a subjective improvement in gastrointestinal function with the supplement After a median follow-up of 28 months, no patients experienced >Grade 1 diarrhea toxicity. 52 (93%) patients are alive, 28 (93%) in the experimental group and 24 (92%) in the control group. Biochemical failure rates were 10% (n=6) (10% experimental vs 11% control). Distant recurrence rates were 9% (n=5)(10%vs 8%) and local recurrence 5% (n=3) (3% vs 8%).