Eligibility criteria | GETUG 14 ( NCT00104741 ) | GETUG 15 ( NCT00104715 ) | GETUG 16 ( NCT00423475 ) | GETUG 17 ( NCT00667069 ) | |
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Disease characteristics | Histology | Histologically confirmed prostate cancer: (Stage T1b-T1c AND PSA ≥10 ng/mL) OR (Stage T1b-T1c AND Gleason score ≥7 OR Stage T2a-T3a)a | Histologically confirmed prostate adenocarcinomaa | Histologically confirmed prostate adenocarcinoma: pT2, pT3, or pT4, pN0 or pNxa | Histologically confirmed prostate adenocarcinoma: pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease, OR pN0 or pNxa |
Disease’s prior treatment | Not specified | Not specified | Treated with surgery onlya | Treated by curative surgery in the past 6 monthsa | |
Positive margins (tumoral glands in contact with contour ink) | |||||
Metastasis | No metastatic disease (M0) confirmed by thoracic radiography and bone scana | Metastatic diseasea | Not specified | Not specified | |
Disease’s exclusion criteria | History of invasive cancera | Brain metastasesa | Clinical signs of progressive disease | pN1 disease, pT2 disease, | |
Lymph node invasion (N0 or N-)a | Other histology than adenocarcinomaa | ||||
PSA/GLEASON score | PSA <30 ng/mL | Not specified | PSA ≤0.1 ng/mL after prostatectomya | PSA ≤0.1 ng/mL after prostatectomya | |
PSA ≥0.2 ng/mL and <2 ng/mL at study entry | Gleason score <8a | ||||
Patient characteristics | Age | Under 75a | 18 and overa | 18 and overa | 18 and overa |
Performance status | ECOG 0-1a | ECOG 0-2a | ECOG 0-1a | ECOG 0-1a | |
Life expectancy | At least 10 yearsa | At least 3 monthsa | ≥10 yearsa | ≥10 yearsa | |
Hematopoietic | Not specified | WBC ≥2,000/mm3 | Not specified | Not specified | |
Absolute neutrophil count ≥1,000/mm3 | |||||
Platelet count ≥100,000/mm3 | |||||
Hepatic | Not specified | Bilirubin ≤1.5 × upper limit of normal (ULN) AND AST, ALT ≤1.5 × ULN | Not specified | Not specified | |
Renal | Not specified | Creatinine ≤150 μmol/L | Not specified | Not specified | |
Cardiovascular | Not specified | No symptomatic coronary diseasea | No uncontrolled hypertension | No uncontrolled hypertension | |
No congenital cardiac insufficiencya | (systolic ≥160, diastolic ≥90 mm Hg) | (systolic ≥160, diastolic ≥90 mm Hg) | |||
NYHA class < III or IVa | |||||
Other diseases | Not specified | No other malignancy (in the past 5 years)a | No other malignancy (in the past 5 years)a | No other malignancy (in the past 5 years) | |
No active infectiona | No known pituitary gland adenomaa | No known hypersensitivity to gonadotropin-releasing hormonea | |||
No severe peripheral neuropathya | No contraindication of intramuscular injectiona | ||||
Other | Not specified | No compliance and follow-up difficulties due to familial, social, geographical, or psychological situationa | No compliance and follow-up difficulties due to familial, social, geographical, or psychological situationa | No compliance and follow-up difficulties due to familial, social, geographical, or psychological situationa | |
Affiliated with social security programa | Affiliated with social security programa | ||||
No patients who are deprived of liberty or under guardianshipa | |||||
Prior concurrent therapy | Chemotherapy | Not specified | No prior chemotherapy for metastatic prostate cancer (within the past year)a | Not specified | Not specified |
Endocrine therapy | No prior hormonal therapya | Prior hormonal therapy within the past 2 months alloweda | No prior hormonal therapya | No prior hormonal therapya | |
Radiotherapy | No prior pelvic radiotherapya | No prior radiotherapy to metastatic sites (within the 4 last weeks) a | No prior pelvic radiotherapya | No prior radiotherapy within 3 months after radical prostatectomya | |
No prior pelvic radiotherapya | |||||
Surgery | No prior radical prostatectomya | No prior surgical castrationa | No prior surgical or chemical castrationa | No prior surgical or chemical castrationa | |
No prior castration | At least 6 months since surgery for biological recurrencea | ||||
Other | Not specified | No concurrent investigational drugsa | No concurrent anticancer therapya | No concurrent participation in another studya |