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Antiandrogen
Enzalutamide + Abiraterone + Prednisone for Prostate Cancer
Phase 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is to study the long-term safety of subjects who are still benefiting from treatment with Enzalutamide.
Who is the study for?
This trial is for individuals with prostate cancer who are benefiting from Enzalutamide in a previous Astellas or Medivation study. They must be able to swallow capsules, not join other trials, and use two forms of birth control if applicable. Those whose cancer worsened on Enzalutamide or need new systemic therapies cannot participate.
What is being tested?
The study aims to collect long-term safety data on the continued use of Enzalutamide, along with abiraterone acetate and prednisone, for those showing clinical benefits from prior studies.
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint discomfort, and hot flushes. Abiraterone can lead to high blood pressure, fluid retention and heart issues. Prednisone might result in weight gain, mood changes and increased infection risk.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in a trial and taking enzalutamide.
Select...
My cancer got worse while I was on enzalutamide in a study.
Select...
I am not currently on any clinical trial treatments except for enzalutamide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: enzalutamide plus abiraterone acetate and prednisoneExperimental Treatment3 Interventions
Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
Group II: enzalutamideExperimental Treatment1 Intervention
Subjects will receive enzalutamide orally once daily at the same time each day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
enzalutamide
2017
Completed Phase 4
~4530
abiraterone acetate
2017
Completed Phase 4
~920
prednisone
1999
Completed Phase 3
~10920
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
121,777 Total Patients Enrolled
7 Trials studying Prostate Cancer
4,276 Patients Enrolled for Prostate Cancer
PfizerIndustry Sponsor
4,625 Previous Clinical Trials
14,283,294 Total Patients Enrolled
43 Trials studying Prostate Cancer
12,003 Patients Enrolled for Prostate Cancer
Associate Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
10 Previous Clinical Trials
1,144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need new treatment for my cancer, but not one I've had before.I can keep taking the same cancer treatment I was on before, unless my doctor changes it.I need new systemic therapy for my cancer, but not treatments I've had before.I am currently in a trial and taking enzalutamide.My cancer got worse while I was on enzalutamide in a study.I am currently on enzalutamide for breast cancer in an Astellas or Medivation/Pfizer study and it's working for me.I am not able to have children, or I can and will follow strict birth control measures during the study.My partner and I use two forms of birth control, including a barrier method, and will continue for 3 months after my last dose.I agree not to donate sperm during and for 3 months after the study.I can swallow capsules and follow the study's rules.I am not currently on any clinical trial treatments except for enzalutamide.I am currently on enzalutamide for prostate cancer in an Astellas or Medivation study and it's working for me.
Research Study Groups:
This trial has the following groups:- Group 1: enzalutamide
- Group 2: enzalutamide plus abiraterone acetate and prednisone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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