Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

Recruitment & Eligibility

Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate
High risk localized adenocarcinoma defined by at least one of the following criteria:
- Clinical stage T2c, T3 or T4
- Gleason score ≥ 8
- Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
No pelvic adenopathy ≥ 15 mm on CT or MRI,
Absence of bone and/or visceral metastasis
Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
Absence of prior pelvic radiotherapy,
Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
Age ≥ 18 years and ≤ 85 years
ECOG performance status ≤ 1,
Estimated life expectancy > 5 years
Membership of a social security system,
Signed informed consent.

Exclusion Criteria

Prostate cancer histology other than adenocarcinoma,
pN1 patients (lymph node dissection after histologically proven)
PSA > 100 ng/ml
History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
Contra-indication to agonists or antagonists of LH-RH
Bilateral hip prosthesis,
Patients already included in another clinical trial with an experimental molecule,
Persons deprived of liberty or under guardianship
Unable to undergo medical test for geographical, social or psychological.

Study & Design

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Simultaneous integrated boost intensity-modulated arctherapy	Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
Radiotherapy	Androgen deprivation	Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation

Primary Outcome Measures

Name	Time	Method
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability	From start of radiotherapy to six months after the end of radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the specific survival	for each patient from inclusion up to 5 years after the end of radiotherapy.
To evaluate the quality of life	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.
Evaluate the 5-year biochemical-free survival	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 late urinary and rectal toxicities	for each patient every 6 months after the end of radiotherapy up to 5 years.
Evaluate the metastase-free survival	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 overall survival	for each patient from inclusion up to 5 years after the end of radiotherapy.

Recruitment & Eligibility