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RECRUITING
NCT03920033
NA

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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

Interventions

RADIATION

Salvage radiation therapy

Salvage radiation therapy for biochemical recurrence

Locations (2)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea