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RECRUITING
NCT07500701
PHASE3

Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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

RADIATION

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).

RADIATION

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