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

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.