Phase 3 Study of HC-1119 verses Enzalutamide
Research type
Research Study
Full title
PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
IRAS ID
247460
Contact name
Vincent Khoo
Contact email
Sponsor organisation
Hinova Pharmaceuticals (USA), Inc.
Eudract number
2019-001144-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 4 days
Research summary
Prostate cancer is a leading cause of cancer deaths in men with disease characterized by clinical states based on extent of disease, hormonal status (ie castration-resistance) and the presence of detectable metastases on radiographical imaging. Most cancer growth and tumour progression is dependent on androgens (male hormones) and blocking the androgen receptor via androgen deprivation therapy (ADT) has been a main treatment. Castration-Resistant prostate cancer (CRPC) is defined by rising prostate specific antigen (PSA) levels (molecules capable of stimulating an immune response) or progressive disease in the setting of serum testosterone levels within castrate range.
The treatment of mCRPC patients has evolved rapidly. However additional treatment options are still needed to improve clinical outcomes and prolong survival in prostate cancer patients.
HC-1119 is an investigational new drug developed as a deuterated derivative of enzalutamide for the treatment of prostate cancers. It may have potential to improve efficacy or drug safety without losing efficacy.
A study evaluating safety, tolerability and pharmacokinetics has provided evidence that HC-1119 could be given to patients at 80mg per day for up to 84 days with acceptable safety profiles and clinical responses in terms of PSA reduction to the same extent as enzalutamide 160mg/day.
The purpose of the study is to evaluate the efficacy and safety of HC-1119 at 80mg/day against enzalutamide 160mg/day in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who have disease progression despite ADT.
It is expected that approximately 430 patients will be enrolled in this study for approximately 2 years. Each hospital visit will take approximately 1 to 3 hours.
Study procedures will include CT/MRI scans, radio nucleotide bone scans, questionnaires, Physical examinations, blood and urine testing.
This is a phase 3, randomised, double blind, non-inferiority study sponsored by Hinova Pharmaceuticals (USA) Inc.Lay summary of study results: Due to the small sample size of the study, meaningful noninferiority comparison could not be made. Both HC-1119 and enzalutamide showed similar efficacy and safety profiles. The early termination due to the challenges with enrollment of the study limits the ability to definitively assess the full potential of HC-1119 as compared to enzalutamide.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0025
Date of REC Opinion
4 Mar 2021
REC opinion
Further Information Favourable Opinion