The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions : * Pelvis : 55,5 Gy (1,85 Gy/fr) * Seminal vesicles : 66 Gy (2,2 Gy/fr) * Prostate : 72 Gy (2,4 Gy/fr)
Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
Centre Georges-François Leclerc
Dijon, Burgundy, France
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
Time frame: From start of radiotherapy to six months after the end of radiotherapy
To evaluate the late urinary and rectal toxicities
Time frame: for each patient every 6 months after the end of radiotherapy up to 5 years.
Evaluate the 5-year biochemical-free survival
Time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
Evaluate the metastase-free survival
Time frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years.
To evaluate the specific survival
Time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the overall survival
Time frame: for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the quality of life
Time frame: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years.
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