Actively Recruiting
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Led by Asan Medical Center · Updated on 2021-01-20
288
Participants Needed
2
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed intermediate- or high-risk prostate cancer
- Biochemical recurrence after radical prostatectomy with PSA between 0.2 and 1.0 ng/mL
- ECOG performance status of 0 or 1
- Blood test values within 6 months showing neutrophil count \u2265 1500 cells/mm3, platelets \u2265 50,000 cells/mm3, and hemoglobin \u2265 8.0 g/dl
- Kidney function within 6 months with creatinine \u003c 2.0 ng/dL
- Liver function within 6 months with total bilirubin \u003c 1.5 times normal and liver enzymes \u003c 2.5 times normal
You will not qualify if you...
- Clinically visible recurrent tumor
- Distant metastasis
- Pelvic lymph node metastasis
- History of pelvic irradiation
- History of cryotherapy or brachytherapy for prostate cancer
- Second primary cancer other than skin or thyroid cancer
- Serious combined medical conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young Seok Kim, M.D., Ph.D.
CONTACT
Y
Yeon Joo Kim, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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