Welcome to thePROCADE Trial Information Portal
- Research Overview
The PROCADE Trial is a randomized, controlled Phase 3 study of HC-1119 Versus Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
- PROCADE Trial Objectives
The primary objective of the trial is to compare the efficacy of HC-1119 versus enzalutamide, as assessed by overall response rate (ORR).
- Secondary objectives include:
To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by decline of PSA ≥ 50% from baseline
To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by radiographic progression-free survival (rPFS)
To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS)
To determine the safety and tolerability of orally administrated HC-1119 as compared to enzalutamide based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
PROCADE Trial
Eligibility CriteriaKey eligibility criteria include the following indicators:
- Eligibility for Inclusion in the Trial
- Men, ages 18 years or older;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration);
- Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit;
- Progressive disease at study entry defined as one or more of the following:
- No prior cytotoxic chemotherapy
- Asymptomatic or mildly symptomatic from prostate cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 as judged by the Investigator;
- Estimated life expectancy of ≥ 6 months
