For our European readers who have not yet started, but are getting ready to start hormone deprivation therapy (ADT), there is a new clinical trial you should consider.

This trial is evaluating MDV3100 monotherapy as the first hormonal treatment of patients with prostate cancer. Enrolled men would not have had any previous hormonal therapies for the treatment of prostate cancer. This is the first trial to examine the effects of MDV3100 without a background of medical or surgical castration castrate responsive ADT naive.

The open-label, single-arm Phase 2 trial (everyone gets the drug) is projected to enroll approximately 60 men in Europe. The primary endpoint of the trial is prostate-specific antigen (PSA) response. The trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily for 24 weeks.

If you are interested in participating in the trial information about eligibility and enrollment can be obtained by calling 800-888-7704 ext. 5473 or e-mailing clintrials.info@us.astellas.com.

MDV3100, which is currently in multiple phase 3 trials, has shown excellent results when compared against Casodex (bicalutamide) in men with advanced prostate cancer. Using MDV3100, an antiandrogen, alone might help a man to avoid many of the side effects commonly associated with LHRH analogue therapy or following surgical castration as well as being a better androgen blocker.

MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In a Phase 1-2 trial in 140 patients with advanced prostate cancer published in The Lancet, encouraging anti-tumor activity was noted with MDV3100 across endpoints. In preclinical experiments published in Science in April 2009, the triple-acting, oral androgen receptor antagonist provided more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions — MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions.

Joel T. Nowak, M.A., M.S.W.