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Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

NCT02446405 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1125

Last updated 2025-02-06

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Enzalutamide

DRUG

NSAA

DRUG

LHRHA or Surgical Castration

Sponsors & Collaborators

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • Cancer Trials Ireland

    collaborator NETWORK

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • University of Sydney

    lead OTHER

Principal Investigators

  • Christopher Sweeney · Dana Farber Cancer Institute and ANZUP

  • Ian Davis · ANZUP and Eastern Health Box Hill Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • New Zealand
  • 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 NCT02446405 on ClinicalTrials.gov