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Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

NCT02446444 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Enzalutamide

DRUG

Conventional NSAA

DRUG

LHRHA

RADIATION

External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)

Sponsors & Collaborators

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Cancer Trials Ireland

    collaborator NETWORK

  • Trans Tasman Radiation Oncology Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • University of Sydney

    lead OTHER

Principal Investigators

  • Scott Williams · ANZUP and Peter MacCallum Cancer Centre

  • Paul Nguyen · Dana Farber Cancer Institute and ANZUP

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
2026-06-30
Completion
2026-06-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Ireland
  • New Zealand
  • Slovenia
  • Spain
  • 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 NCT02446444 on ClinicalTrials.gov