A Randomized, Controlled, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET, with an Observational Cohort

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505852-23-00

Acronym

56021927PCR3015

Enrollment

290

Registered

2024-02-21

Start date

2020-11-12

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

High risk recurrent prostate cancer previously treated with radical prostatectomy

Brief summary

PSMA-PET metastatic progression-free survival (ppMPFS): Defined as the time from randomization to the (scan) date of metastatic progression by PSMA PET (as determined by BICR) or death from any cause.

Interventions

DRUG-

DRUGTECHNETIUM (99MTC) COMPOUNDS

DRUGJNJ-56021927

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PSMA-PET metastatic progression-free survival (ppMPFS): Defined as the time from randomization to the (scan) date of metastatic progression by PSMA PET (as determined by BICR) or death from any cause.	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, Germany, Hungary, Italy, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

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