Biochemical Recurrence, Dose Escalation, Hypofractionation, Prostate Cancer, Quality of Life, Radiation, Radiation Toxicity, Survival
Conditions
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.
Interventions
RADIATIONSalvage radiation therapy
Salvage radiation therapy for biochemical recurrence
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical recurrence-free survival | 5 years | PSA \>0.2 ng/mLfollowed by a repeat measurement \>0.2 ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicities | Adverse effects occured during radiation therapy, and within 3 months after radiation therapy | Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0 |
| Chronic toxicities | Adverse effects occured after 3 months since end of radiation therapy | Evaulation using CTCAE 4.0 |
| Quality of life 1 | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years | 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. |
| Quality of life 2 | the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years | 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. |
Countries
South Korea
Contacts
Primary ContactYoung Seok Kim, M.D., Ph.D.
Backup ContactYeon Joo Kim, M.D.
Outcome results
None listed