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Trial Summary

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Acronym:

PRIMORDIUM

ACTRN/NCT /ethics:

NCT04557059

Scientific title:

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 PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, With an Observational Follow-up of PSMA-PET-Negative Patients

Sponsor / Cooperative group:

Janssen Pharmaceutica N.V., Belgium

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexMale
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2020-11-12
Anticipated End Date2028-01-14

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal Investigator-
Recruitment StatusCompleted