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A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

NCT02288247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2025-04-08

Study results available
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Summary

The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Enzalutamide

Oral

DRUG

Docetaxel

intravenous infusion

DRUG

Prednisolone

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Europe Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2020-04-30
Completion
2024-03-15
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288247 on ClinicalTrials.gov