Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study
- 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
- 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
- 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
- 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.