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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Asan Medical Center
- Enrollment
- 288
- Locations
- 2
- Primary Endpoint
- Biochemical recurrence-free survival
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Young Seok Kim
Professor
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed intermediate- or high-risk prostate cancer
- •Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL)
- •ECOG performance status 0-1
- •Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
- •Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
- •Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value
Exclusion Criteria
- •Clinically gross recurrent tumor
- •Presence of distant metastasis
- •Presence of pelvic LN metastasis
- •History of pelvic irradiation
- •History of cryotherapy or brachytherapy for prostate cancer
- •Double primary cancer other than skin/thyroid cancer
- •Combined serious morbidity
Outcomes
Primary Outcomes
Biochemical recurrence-free survival
Time Frame: 5 years
PSA \>0.2 ng/mLfollowed by a repeat measurement \>0.2 ng/mL
Secondary Outcomes
- Quality of life 1(the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years)
- Chronic toxicities(Adverse effects occured after 3 months since end of radiation therapy)
- Quality of life 2(the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years)
- Acute toxicities(Adverse effects occured during radiation therapy, and within 3 months after radiation therapy)