A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Metastatic Hormonesensitive Prostate Cancer (mHSPC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508607-20-00

Acronym

56021927PCR3002

Enrollment

Registered

2024-03-01

Start date

2015-11-27

Completion date

Unknown

Last updated

2025-08-12

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

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Brief summary

Radiographic Progression-Free Survival (rPFS), Overall Survival (OS)

Detailed description

Time to Pain Progression, Time to Skeletal-Related Event (SRE), Time to Chronic Opioid Use, Time to Initiation of Cytotoxic Chemotherapy

Interventions

DRUGApalutamide placebo

DRUG-

DRUGJNJ-56021927

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiographic Progression-Free Survival (rPFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
Time to Pain Progression, Time to Skeletal-Related Event (SRE), Time to Chronic Opioid Use, Time to Initiation of Cytotoxic Chemotherapy	—

Countries

Czechia, Romania, Spain

Outcome results

None listed

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