Early adverse events and patient-reported outcomes after salvage radiotherapy following prostatectomy according to fractionation schedule: Interim analysis of the phase III URONCOR 06-24 trial
In brief
Moderate-dose salvage radiotherapy yields similar early GU toxicity as conventional
In the first 250 men treated after prostatectomy, grade 2 or higher genitourinary side effects occurred in 22% with moderate hypofractionation versus 17% with conventional schedules, while gastrointestinal toxicity was 11% versus 4% and patient-reported outcomes were unchanged. The early safety profile appears comparable, but longer follow-up and adjustment for treatment-selection bias are still needed.
- Journal
- Clinical and translational radiation oncology (Q1)
- Published
- 30 August 2026
- Study design
- Non-randomized / quasi-experimental trial
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Felipe Couñago, Carmen González, Alfonso Gómez-Iturriaga, Ana Álvarez, Marina Santos, Ana Boladeras, et al.
- PMID
- 42741462
- DOI
- 10.1016/j.ctro.2026.101276
Why clinicians should know about it
- Picked for Radiology, Radiation Oncology, Nuclear Medicine, Medical Physics and Imaging (paper of the day, 20 September 2026): Salvage radiotherapy after prostatectomy trial, directly relevant
Abstract
BACKGROUND AND PURPOSE: Moderate hypofractionation is increasingly used in salvage radiotherapy (SRT) after radical prostatectomy, although prospective data in the postoperative setting remain limited. We evaluated early adverse events and patient-reported outcomes (PROs) according to fractionation schedule within a prospective multicenter phase III trial. MATERIALS AND METHODS: This prespecified interim analysis included the first 250 patients enrolled in the URONCOR 06-24 randomized trial (NCT05781217). SRT was delivered using moderate hypofractionation (n = 175), most commonly 62.5 Gy in 25 fractions (80.5%), followed by 65.25 Gy in 29 fractions (7.5%), 60 Gy in 24 fractions (4.6%), and 52.5 Gy in 20 fractions (2.9%), corresponding to a biologically equivalent dose (EQ.D2) of approximately 65-71 Gy (α/β = 1.5), or conventional fractionation (n = 75; 66-70 Gy in 33-35 fractions). Adverse events were assessed using CTCAE v5.0. PROs were evaluated using EPIC-26 and EORTC QLQ-C30 at baseline, 3, and 6 months. RESULTS: With a median follow-up of 12.7 months, grade ≥ 2 genitourinary (GU) adverse events occurred in 21.7% of patients treated with hypofractionation versus 17.3% with conventional fractionation (p = 0.431). Grade ≥ 2 gastrointestinal (GI) adverse events occurred in 10.8% and 4.0%, respectively (p = 0.079). Pelvic nodal irradiation was more frequent in the hypofractionation group (39.4% vs 13.3%, p = 0.001). On multivariable analysis, age was associated with increased risk of GU ≥2 adverse events, while pelvic nodal irradiation was associated with increased risk of GI ≥2 adverse events. No clinically meaningful differences were observed in PROs. CONCLUSION: Early adverse events after SRT were low and comparable between fractionation schedules, and moderate hypofractionation showed a similar safety profile despite more frequent pelvic irradiation. However, given the non-randomized nature of the fractionation schedules, longer follow-up and robust adjustment for treatment-selection biases are needed before drawing definitive conclusions regarding comparative safety.
Abstract as published, via PubMed.
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