NCT03920033

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Biochemical Recurrence
• Radiation
• Hypofractionation
• Dose Escalation
• Survival
• Radiation Toxicity
• Quality of Life

Interventions

Type	Name	Description
RADIATION	Salvage radiation therapy	Salvage radiation therapy for biochemical recurrence

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-01-01
• Completion: 2027-01-01
• First posted: 2019-04-18
• Last updated: 2021-01-20

Locations

2 sites across 1 country: South Korea