Pelvic nodes ultra-hypo fractionated versus conventionally fractionated IMRT with HDR brachytherapy in prostate cancer: interim analysis of a collaborative multi-institutional non-inferiority phase 3 trial (PCS-XI, NCT05820633)
Abstract
Purpose: Ultra-hypofractionation (UHF) has emerged as a safe and effective strategy; however, its role in prostate cancer (PCa) pelvic nodal irradiation combined with high-dose-rate brachytherapy (HDR-BT) and androgen deprivation therapy (ADT) remains insufficiently defined. PCS-XI (NCT05820633) is a multicentre, phase III randomized trial evaluating pelvic UHF versus conventionally fractionated (CF) radiotherapy. We report a prespecified interim analysis focusing on toxicity and patient-reported outcomes (PROs).
Methods: Men with unfavorable-intermediate to very-high-risk prostate adenocarcinoma were enrolled. Patients were randomized 1:1 to CF (43 Gy/20 fractions, 44 Gy/22 fractions, or 46 Gy/23 fractions) or UHF (25 Gy in 5 fractions delivered every other day) whole pelvis radiotherapy, combined with single-fraction 15 Gy HDR-BT to the prostate with concomitant ADT. Genitourinary and gastrointestinal toxicities (CTCAE v5.0) and PROs (IPSS, SHIM, EPIC-26) were collected longitudinally.
Results: At interim analysis, 142 patients were randomized (CF = 73; UHF = 69), with a median follow-up of 17.6 months. Baseline clinicopathologic characteristics, ADT exposure, and treatment volumes were well balanced between arms. Grade 2-3 GU and GI toxicity rates were low and comparable between arms. No grade 4-5 toxicities were observed. Longitudinal PRO analyses demonstrated parallel trajectories. Clinically meaningful differences favoring UHF were observed for urinary incontinence at…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 142 participants or records.
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