A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

You may be able to join if

• IRB/IEC approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act authorization for the United States sites] must be obtained from the subject prior to any study-related procedures.
• Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator’s assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
• Subjects are able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator’s assessment a change is needed to the subject’s regimen approval (e.g., dose change in androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
• Subject is able to swallow enzalutamide capsules and comply with study requirements.
• Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration. Two acceptable forms of birth control include: ‡ Condom (barrier method of contraception), AND † In addition to a condom, 1 of the following acceptable forms of contraception is required: ● Established use of oral, injected or implanted hormonal methods of contraception ● Placement of an intrauterine device or intrauterine system ● Tubal ligation ● Vasectomy or other surgical castration prior to initial screening
• Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.