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Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

NCT01949337 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1311

Last updated 2023-09-28

Study results available
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Summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Conditions

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

DRUG

enzalutamide

Enzalutamide 160 mg daily, orally

DRUG

abiraterone

abiraterone 1000 mg daily, orally

DRUG

prednisone

prednisone 5 mg twice daily, orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY

  • Medivation, Inc.

    collaborator INDUSTRY

  • Biologics, Inc.

    collaborator INDUSTRY

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Michael Morris, M.D. · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-22
Primary Completion
2018-11-02
Completion
2024-08-31

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT01949337 on ClinicalTrials.gov