HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy
and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic
or mildly symptomatic patients with progressive metastatic castration-resistant prostate
cancer (mCRPC).
The following assessment of prostate cancer status will be collected during the course of the
trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging
(MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory,
and PSA.
Throughout the study, safety and tolerability will be assessed by the recording of adverse
events, monitoring of vital signs and physical examinations, safety laboratory evaluations,
and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for
HC-1119 and enzalutamide and related metabolites will be collected.