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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until end of study (up to 96 months)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until end of study (up to 96 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of study (up to 96 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events

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
192 Previous Clinical Trials
120,162 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,834 Patients Enrolled for Prostate Cancer
PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,906,226 Total Patients Enrolled
41 Trials studying Prostate Cancer
11,469 Patients Enrolled for Prostate Cancer
Associate Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
10 Previous Clinical Trials
1,144 Total Patients Enrolled

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02960022 — Phase 2
Prostate Cancer Research Study Groups: enzalutamide, enzalutamide plus abiraterone acetate and prednisone
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02960022 — Phase 2
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02960022 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this experiment?

"Affirmative. Clinicaltrials.gov data affirms that this clinical trial, which first appeared on December 22nd 2016, is currently soliciting participants. The study requires 900 persons to be recruited from 1 site."

Answered by AI

What other trials have been conducted to assess the impact of enzalutamide?

"Currently, there are 437 active studies analyzing the efficacy of enzalutamide, with 119 being in Phase 3. Although most research sites for this drug can be found in Germantown, Tennessee; a total of 21159 centres across the world have been enrolled to undertake these trials."

Answered by AI

What primary indications are addressed with enzalutamide therapy?

"Enzalutamide is often prescribed for thyroiditis, but it also possesses properties that make it a viable treatment option for ulcerative colitis, cancerous tumours, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Has enzalutamide received the necessary clearance from the FDA?

"With regards to safety, enzalutamide has been awarded a score of 2 as there is some evidence that it can be administered without causing harm yet no clinical data showing the drug's efficacy."

Answered by AI

What is the exact number of people enrolled in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this research program is accepting participants at present; it was originally posted on December 22nd 2016 and has been recently updated on September 29th 2022. 900 individuals are needed for this study which will take place in a single location."

Answered by AI
~219 spots leftby Jul 2026