Enzalutamide for Prostate Cancer (Long-Term Safety Study)
This study is for men with prostate cancer who are already receiving enzalutamide as part of a previous clinical study sponsored by Astellas or Medivation. The main goal is to gather long-term information about the safety of enzalutamide. Some participants may also receive abiraterone acetate and prednisone, or leuprolide acetate, depending on their previous study. You can join if you are currently benefiting from enzalutamide treatment in one of these prior studies. The study aims to enroll 900 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 900 participants. The phase is not specified.
- What's involved
- You would continue your current treatment regimen and attend visits every 24 weeks (or every 12 weeks for drug collection) for up to 96 months to review side effects and medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events until the end of the study, which could be up to 96 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02960022
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentAstellas Pharma Global Development, Inc.
~900 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:enzalutamideabiraterone acetateprednisoneLeuprolide acetate
At a glance
Recruiting sites
0 of 234 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events
Measured over Until End of Study (Up to 96 Months)
Conditions
Where it's being run
234 sites across 84 statesFrance12
United Kingdom11
South Korea10
Spain9
Australia8
Belgium8
Italy7
Slovakia7
Study leadership
- Associate Medical Director · STUDY_DIRECTOR · Astellas Pharma Global Development, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Subject must currently be receiving enzalutamide for breast 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.
Subject is 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 (e.g., 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 is either:
Of nonchildbearing potential:
postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
Or, if of childbearing potential,
must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
A barrier method (e.g., condom by a male partner) is required; AND
One of the following is required:
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
Vasectomy or other surgical castration at least 6 months before Day 1.
The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment.
Exclusion
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.
Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
Subject requires treatment with or plans to use any of the following:
New systemic therapy for their 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 in the opinion of the investigator.
What this trial measures
- Number of participants with adverse eventsUntil End of Study (Up to 96 Months)