← Back to Search

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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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