PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence. SECONDARY OBJECTIVE(S): * PSA evolution * Evaluation of testosterone level * Specific survival * Overall survival * Tolerance * Quality of life (QLQ-C30 questionnaires)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy.
Time frame: The principal criterion will be evaluated 12 years after the inclusion of the first patient.
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Clinique Victor Pauchet
Amiens, France
Chu Besancon
Besançon, France
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Bordeaux, France
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Bordeaux, France
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Brest, France
Hopital Henri Mondor
Créteil, France
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Dijon, France
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Lille, France
Chu Limoges
Limoges, France
...and 25 more locations