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Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505246-26-00
Acronym
56021927PCR3003
Enrollment
635
Registered
2023-10-09
Start date
2016-01-27
Completion date
Unknown
Last updated
2025-12-16

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

Conditions

High- or very-high risk, localized or locally advanced prostate cancer

Brief summary

MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assesed by BICR, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.

Interventions

DRUG-
DRUGBicalutamid PUREN 50 mg Filmtabletten

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assesed by BICR, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.

Countries

Belgium, Czechia, France, Germany, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed

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