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Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer
Sponsor: Samsung Medical Center
Summary
This study is the first prospective, randomized phase III clinical trial designed to evaluate whether ultrahypofractionated radiotherapy is non-inferior to conventionally moderately hypofractionated radiotherapy in terms of efficacy, with acceptable toxicity, in patients who develop biochemical recurrence following radical prostatectomy. Considering the potential clinical benefits of shorter treatment duration, cost reduction, and improved patient convenience, this study is expected to provide important evidence to optimize salvage radiotherapy strategies in routine clinical practice.
Official title: Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer: A Prospective, Multi-Center, Randomized Phase III Non- Inferiority Trial (HUB Trial)
Key Details
Gender
MALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-03-06
Completion Date
2034-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Moderate hypofractionated radiotherapy (Moderate-hypoRT)
Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions (administered once daily on weekdays, five times per week, over a total of 5-6 weeks).
Ultra-hypofractionated radiotherapy (Ultra-hypoRT)
Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions (administered every other day, 2-3 times per week, over a total of 2 weeks).
Locations (1)
Samsung Medical Center
Seoul, Gangnam-gu, South Korea