 23. Concomitant therapy with any of the following: a Chemotherapeutic, biologic, or other agents with anti-tumor activity against prostate cancer other than assigned study drug; b Anti-androgens steroidal or non-steroidal such as cyproterone acetate, flutamide, nilutamide, bicalutamide, etc. other than assigned study drug; c 5-alpha reductase inhibitors such as finasteride, dutasteride, anabolic steroids, etc.; d Estrogens, progestational agents such as megestrol, medroxyprogesterone, DES, cyproterone, spironolactone 50 mgkg, etc.; e Androgens such as testosterone, dehydroepiandrosterone DHEA, etc.; f Ketoconazole; g Herbal products that may decrease PSA levels e.g., saw palmetto 