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Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Sponsor: Asan Medical Center
Summary
Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence. It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.
Official title: Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study
Key Details
Gender
MALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2019-05-01
Completion Date
2027-01-01
Last Updated
2021-01-20
Healthy Volunteers
No
Conditions
Interventions
Salvage radiation therapy
Salvage radiation therapy for biochemical recurrence
Locations (2)
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea