PROCADE Trial

This is an educational resource for health care professionals to learn more about the ongoing trial and to determine the eligibility for patient enrollment in the trial.

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.

Eligibility Criteria

Key eligibility criteria include the following indicators:

Inclusion

Exclusion

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 three criteria that occurred while the patient was on androgen deprivation;
  - 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 Investigators' clinical assessment;
  - Estimated life expectancy of ≥ 6 months
Subjects must NOT meet any of the following exclusion criteria:
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
- Known or suspected brain metastasis or active leptomeningeal disease;
- Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrollment (Day 1 visit);
- Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit;
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the Screening visit;
- Creatinine > 177 µmol/L (2 mg/dL) at the Screening visit;
- Albumin < 30 g/L (3.0 g/dL) at the Screening visit;
- Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone, galeterone, seviteronel) or blocks the androgen receptor (e.g., apalutamide, duralutamide, enzalutamide, proxalutamide);
- Participation in a previous clinical trial of HC-111v9;
- Radiation therapy for treatment of the primary tumor within three weeks of enrollment
- Radionuclide therapy for treatment of metastasis;

Find out more about the PROCADE Trial

Learn More

Welcome to the PROCADE Trial Information Portal

PROCADE Trial

You are now leaving this page