RecruitingProstate Cancer

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

Eligible age

18+ yrs

Accepts

Men

Locations

24 states

Healthy volunteers

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About this study

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Sponsor: Astellas Pharma Global Development, Inc.

You may qualify if…

✓ Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
✓ Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (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 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.
✓ Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
✓ Subject agrees not to participate in another interventional study while on treatment.
✓ Canada Specific:
✓ Institutional Review Board (IRB)/Independent Ethics Committee (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.

You may not qualify if…

✕ Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
✕ Subject requires treatment with or plans to use either of the following:
✕ New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
✕ Investigational therapy other than enzalutamide.
✕ Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
✕ Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
✕ Canada Specific:
✕ Subject will be excluded from participation if any of the following apply: