Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer

Inclusion Criteria: * Prior confirmed histological diagnosis of prostatic carcinoma. * Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the time of study entry. * No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and spiral thoracoabdominopelvic CT scan. * Effective castration throughout the study. Any prior anti-androgen therapy should be stopped with documented continued elevation of PSA 4 weeks after the cessation of flutamide (6 weeks for bicalutamide). * Serum testosterone levels \< 50ng/dL at the time of progression and throughout the study. * Age \> or = to 18 years. * Extensive metabolizer by CYP2D6 genotyping. * Karnofsky Performance Status \> or = to 70% and life expectancy \> 6 months. * Adequate hematological, renal and liver function. * Signed written informed consent Exclusion Criteria: * Poor metabolizers by CYP2D6 genotyping. * Prior palliative radiotherapy or any prior chemotherapy or experimental therapy. * More than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry. * Concomitant administration of biphosphonate or chronic corticosteroids. * Presence of progressive symptoms not adequately controlled with non opioid medications * Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed in protocol appendice * Previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer * Other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.