Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial.

PURPOSE: Compared to conventional fractionated radiotherapy (CFRT), which delivers lower doses over a longer period, moderate hypofractionated radiotherapy (HFRT) administers higher doses in a shorter period. Increasing evidence has demonstrated that the safety and efficacy of moderate HFRT in 20-28 fractions for localized PCa are equal to those of CFRT. However, the optimal and lowest fractions of moderate HFRT need to be explored for localized PCa. Therefore, this trial aims to investigate the safety outcomes of HFRT in 15 fractions for treating patients with localized PCa.

METHODS AND ANALYSIS: This is a single-center, single-arm, open-label clinical trial. Patients with localized PCa will be enrolled to receive HFRT (54 Gy delivered in 15 daily fractions of 3.6 Gy). The primary outcome measures are the incidence of radiotherapy-related gastrointestinal (GI) and genitourinary (GU) symptoms and erectile dysfunction. Secondary outcome measures include biochemical progression-free survival (bPFS), local progression-free survival (LPFS), distant metastasis-free survival (DMFS), overall survival (OS), and quality of life (QoL).

CLINICAL TRIAL REGISTRATION: NCT06325774 (Clinicaltrials.gov).