Hormone refractory/hormone resistant PCa

AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer) [012010]

Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.

The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.

For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com