Trial intelligence / Profile preview

ENZARAD

NCT02446444Phase 3

Key facts

Status: Active, not recruiting
Start: Mar 2014
Primary completion: Jun 2026
Countries: 9
Sponsor: University of Sydney
Modality: Small Molecules

Drugs: enzalutamide
Conditions: prostate cancer (PCa)

Overview

Phase 3, randomised, open-label trial of enzalutamide in prostate cancer (PCa) (2 arms), sponsored by University of Sydney. Primary endpoint: Metastasis-free survival at 5 years. Started Mar 2014; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Enzalutamide
Enzalutamide + LHRHA + EBRT
Conventional NSAA
Conventional NSAA + LHRHA + EBRT

Who it enrols

Men ≥18 years with high-risk localized prostate adenocarcinoma suitable for external beam radiation therapy, with adequate organ function and ECOG 0-1. Excludes patients with distant metastases, prior radiotherapy overlapping fields, or prior hormonal therapy (except short-term LHRHA).

Endpoints

Primary

Metastasis-free survival5 years

Secondary

Overall survival5 years
Prostate cancer-specific survival5 years
PSA progression-free survival5 years
Clinical progression-free survival5 years
Time to subsequent hormonal therapy5 years
Time to castration-resistant disease5 years
Adverse events5 years
Health related quality of life5 years

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