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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
Janssen Pharmaceutica N.V., Belgium
This is a randomised, open-label trial which consists of two cohorts: interventional and observational. Within the intervention cohort, there are two groups: Group 1 (Active Comparator) will receive RT + LHRHa, and Group 2 (Experimental) will receive RT + LHRHa + Apalutamide. Eligible participants will undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET), whole-body Tc-bone scan, computed tomography (CT). Participants in Interventional Group 1 will receive RT with or without optional stereotactic body radiation therapy (SBRT), beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. Participants in Interventional Group 2 will receive RT with or without SBRT, beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. These participants will also receive 240mg of apalutamide starting within 3 days after randomisation, to be taken orally, once daily, for 180 days. Participants in the Observational Cohort will be those who are PSMA-PET-negative at screening. Data from this group will be collected in the course of routine clinical practice and will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status.