A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509221-47-00

Acronym

ARN-509-003

Enrollment

Registered

2024-03-01

Start date

2014-02-12

Completion date

Unknown

Last updated

2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration-Resistant Prostate Cancer

Brief summary

Metastasis-Free Survival (MFS)

Detailed description

For the secondary endpoints, a hierarchical testing will be performed in the following order: -Time to Metastasis (TTM) -Progression-Free Survival (PFS) -Time to symptomatic progression -Overall Survival (OS) -Time to initiation of cytotoxic chemotherapy

Interventions

DRUGZYTIGA 250 mg tablets

DRUGZYTIGA 500 mg film-coated tablets

DRUGApalutamide placebo

DRUGJNJ-56021927

DRUGPREDNISONE

DRUG-

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Metastasis-Free Survival (MFS)	—

Secondary

Measure	Time frame
For the secondary endpoints, a hierarchical testing will be performed in the following order: -Time to Metastasis (TTM) -Progression-Free Survival (PFS) -Time to symptomatic progression -Overall Survival (OS) -Time to initiation of cytotoxic chemotherapy	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026