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
About This Trial
- This study is for men whose prostate cancer may be returning after surgery, indicated by rising PSA levels in their blood.
- Researchers are testing whether a shorter course of radiation with slightly higher daily doses works better at controlling the cancer and protecting quality of life compared to the standard, longer radiation schedule.
- If you join, you will be randomly assigned to receive either the shorter 26-treatment schedule or the traditional 33-treatment plan.
- Before considering this trial, you should know that your cancer must not have spread to other parts of your body, and you cannot have received radiation to the pelvic area in the past.
More Information
- 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.
Who Can Enroll
- Age Range: 20 years and older
- Gender: Male
- Who This Trial is For: This study is for men whose prostate cancer may be returning after surgery, indicated by rising PSA levels in their blood.
Study Details
- Start Date: May 1, 2019
- Lead Sponsor: Asan Medical Center
Full 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
Treatments
- Radiation: Salvage radiation therapy