Open Label Phase II Study of Enzalutamide With Concurrent Administration of Radium 223 Dichloride in Patients With...

Area of Science:

• Oncology
• Uro-oncology
• Pharmacology

Background:

• Castration-resistant prostate cancer (CRPC) has multiple approved therapies.
• Enzalutamide and radium 223 (Ra 223) are approved for CRPC, offering survival benefits but with different mechanisms and safety profiles.
• Investigating the combined safety and tolerability of these agents is crucial for treatment optimization.

Purpose of the Study:

• To prospectively evaluate the safety and tolerability of combined enzalutamide and Ra 223 therapy in metastatic CRPC.
• To assess the impact of the combination therapy on quality of life and pain.
• To identify any unexpected toxicities associated with the combination.

Main Methods:

• A phase II investigator-initiated trial (EnzaRadiCate) enrolled patients with metastatic CRPC.
• Safety was assessed through physical exams, ECOG status, ECGs, labs, opioid use, radiographic response, and adverse events (AEs).
• Quality of life and pain were measured using FACT-P and BPI-SF questionnaires.

Main Results:

• Most patients (87%) completed all 6 cycles of Ra 223.
• Common AEs included fatigue (25.6%), nausea (17.9%), and anemia (12.8%); 53.8% of subjects reported treatment-related AEs.
• No unexpected toxicities, falls, fractures, or deaths were observed; 61.5% of subjects showed no radiographic progression.

Conclusions:

• Combined enzalutamide and Ra 223 demonstrated acceptable safety and tolerability in metastatic CRPC.
• Patients reported improvements in quality of life and pain.
• Phase III trials are ongoing to further assess radiographic progression and survival benefits.