Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Location status: Recruiting
NCT Number: NCT07500701
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.
Interested in participating?
Request Info20 year and older
Male
Interventional
Phase 3
Seoul, Gangnam-gu, 06351, South Korea
Location status: Recruiting
Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions, delivered once daily, 5 days per week (on weekdays), over a total of 5-6 weeks.
Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions, delivered every other day (2-3 fractions per week), over a total of 2 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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):
31 Gy in 5 fractions (administered every other day, 2-3 times per week, over a total of 2 weeks).
Time frame: 5 years after treatment completion
Time frame: 5 years after treatment completion
Time frame: 5 years after treatment completion
Time frame: 5 years after treatment completion
Time frame: 5 years after treatment completion
Time frame: During treatment and follow-up
Contact information is provided by the study sponsor or research team.
Samsung Medical Center
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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