Table 1 Eligibility criteria of GETUG 14, GETUG 15, GETUG 16, and GETUG 17 clinical trials

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 adenocarcinoma^a

Histologically confirmed prostate adenocarcinoma: pT2, pT3, or pT4, pN0 or pNx^a

Histologically confirmed prostate adenocarcinoma: pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease, OR pN0 or pNx^a

Disease’s prior treatment

Not specified

Not specified

Treated with surgery only^a

Treated by curative surgery in the past 6 months^a

Positive margins (tumoral glands in contact with contour ink)

Metastasis

No metastatic disease (M0) confirmed by thoracic radiography and bone scan^a

Metastatic disease^a

Not specified

Not specified

Disease’s exclusion criteria

History of invasive cancer^a

Brain metastases^a

Clinical signs of progressive disease

pN1 disease, pT2 disease,

Lymph node invasion (N0 or N-)^a

Other histology than adenocarcinoma^a

PSA/GLEASON score

PSA <30 ng/mL

Not specified

PSA ≤0.1 ng/mL after prostatectomy^a

PSA ≤0.1 ng/mL after prostatectomy^a

PSA ≥0.2 ng/mL and <2 ng/mL at study entry

Gleason score <8^a

Patient characteristics

Age

Under 75^a

18 and over^a

18 and over^a

18 and over^a

Performance status

ECOG 0-1^a

ECOG 0-2^a

ECOG 0-1^a

ECOG 0-1^a

Life expectancy

At least 10 years^a

At least 3 months^a

≥10 years^a

≥10 years^a

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 disease^a

No uncontrolled hypertension

No uncontrolled hypertension

No congenital cardiac insufficiency^a

(systolic ≥160, diastolic ≥90 mm Hg)

(systolic ≥160, diastolic ≥90 mm Hg)

NYHA class < III or IV^a

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 infection^a

No known pituitary gland adenoma^a

No known hypersensitivity to gonadotropin-releasing hormone^a

No severe peripheral neuropathy^a

No contraindication of intramuscular injection^a

Other

Not specified

No compliance and follow-up difficulties due to familial, social, geographical, or psychological situation^a

No compliance and follow-up difficulties due to familial, social, geographical, or psychological situation^a

No compliance and follow-up difficulties due to familial, social, geographical, or psychological situation^a

Affiliated with social security program^a

Affiliated with social security program^a

No patients who are deprived of liberty or under guardianship^a

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 therapy^a

Prior hormonal therapy within the past 2 months allowed^a

No prior hormonal therapy^a

No prior hormonal therapy^a

Radiotherapy

No prior pelvic radiotherapy^a

No prior radiotherapy to metastatic sites (within the 4 last weeks) ^a

No prior pelvic radiotherapy^a

No prior radiotherapy within 3 months after radical prostatectomy^a

No prior pelvic radiotherapy^a

Surgery

No prior radical prostatectomy^a

No prior surgical castration^a

No prior surgical or chemical castration^a

No prior surgical or chemical castration^a

No prior castration

At least 6 months since surgery for biological recurrence^a

Other

Not specified

No concurrent investigational drugs^a

No concurrent anticancer therapy^a

No concurrent participation in another study^a