Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Study Overview
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Brief Summary
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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
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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

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

Intervention / Treatment
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* Radiation: Salvage radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated<br>65 Gy/ 26 fractions (fraction size 2.5 Gy) | Radiation: Salvage radiation therapy<br>* Salvage radiation therapy for biochemical recurrence<br>|
| Active Comparator: Standard<br>66 Gy/ 33 fractions (fraction size 2 Gy) | Radiation: Salvage radiation therapy<br>* Salvage radiation therapy for biochemical recurrence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical recurrence-free survival | PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicities | Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0 | Adverse effects occured during radiation therapy, and within 3 months after radiation therapy | 
| Chronic toxicities | Evaulation using CTCAE 4.0 | Adverse effects occured after 3 months since end of radiation therapy | 
| Quality of life 1 | Expanded prostate cancer index composite (EPIC) Questionnaire Korean version EPIC consists of 50 questions in total divided into four domains: bowel (14 questions), urinary (12 questions), sexual (13 questions), and hormonal aspects (13 questions). Scores of each domain will be separately reported. Response options for each EPIC item form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale. The higher the score, the higher the quality of life. | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years | 
| Quality of life 2 | European Organization for Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) Korean version EORTC QLQ-C30 consists of 30 questions, and total score will be reported. Response options for each EPIC question form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale. The higher the score, the higher the quality of life. | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years |