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Prostate Cancer MetastaticPhase 3NCT03850795

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 3 study testing HC-1119 and Enzalutamide in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Hinova Pharmaceuticals USA, Inc. at 58 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
HC-1119 and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
58 sitesin 14 countries
Study dates
15 Mar 2021to 28 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet the following inclusion criteria:
  • Age 18 or older and willing and able to give informed consent.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
  • Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
  • For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
  • Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit.
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  • Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
  • Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on ADT as defined in eligibility criterion #3:
  • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 µg/L (2 ng/mL)
  • Soft tissue disease progression defined by RECIST 1.1
  • Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
  • Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
  • No prior cytotoxic chemotherapy for prostate cancer.
  • Asymptomatic or mildly symptomatic from prostate cancer.
  • ECOG performance status of 0-1 per the Investigators' clinical assessment
  • Estimated life expectancy of ≥ 6 months
  • Able to swallow the study drug and comply with study requirements
  • All sexually active patients are required to use a condom as well as meet 1 of the following:
  • Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
  • Patient and his female partner must agree to use an adequate contraceptive method from the first day of dosing until 3 months after the last dose to prevent pregnancies. Adequate contraceptive method is defined as:
  • Established use of oral, injected, or implanted hormonal methods of contraception.
  • Placement of an intra-uterine device or intra-uterine system. iii. Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Tubal ligation for at least 6 months prior to screening.
  • Male patient engaged in sexual activity with a pregnant female is required to use a condom from the first day of dosing until 3 months after the last dose of treatment with study drugs.

Who cannot join

  • 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).
  • WBC count < 3,000/µL, or absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors or blood transfusions or any therapeutic invention within 14 days of the hematologic laboratory values obtained 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; no therapeutic invention within 14 days before screening.
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  • Creatinine clearance < 30 mL/min as calculated using the Cockcroft-Gault equation at the Screening visit. Creatinine Clearance (mL/min) = [[140-Age (years)] * Weight (kg)] / [72 * Serum Creatinine (mg/dL)]
  • Albumin < 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening.
  • History of another malignancy within the previous two years other than curatively treated non-melanomatous skin cancer.
  • Treatment with flutamide within four weeks of enrollment (Day 1 visit).
  • Treatment with bicalutamide or nilutamide within six weeks of enrollment (Day 1 visit).
  • Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens within four weeks of enrollment (Day 1 visit).
  • Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within four weeks of enrollment (Day 1 visit).
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrollment (Day 1 visit).
  • Prior use, or participation in a clinical trial, of an agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, enzalutamide, proxalutamide).
  • Participation in a previous clinical trial of HC-1119.
  • Use of an investigational agent within four weeks of enrollment (Day 1 visit).
  • Radiation therapy for treatment of the primary tumor within three weeks of enrollment (Day 1 visit).
  • Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrollment (Day 1 visit).
  • Clinically significant cardiovascular disease or condition
  • Treatment with strong CYP2C8 inhibitors and inducers, CYP3A4 inducers, medications which are known to prolong the QT interval (see Appendix C).
  • History of seizure or any condition that may predispose to seizure.
  • Conditions that predispose subjects to increased risk for falls or fractures according to the discretion of the Investigator.
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months).
  • Major surgery within four weeks prior to enrollment (Day 1 visit).
  • Have active infection with HBV measured by hepatitis B surface antigen (HBsAg) test, HCV measured by RNA test and HIV measured by antibody test.
  • Have known active tuberculosis.
  • Known hypersensitivity to HC-1119, enzalutamide, or any of the excipients.
  • Rare hereditary problems of fructose intolerance due to sorbitol

Trial locations and contacts

58 sites in 14 countries.

58 sites in 14 countries

United States8 sites

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Urology Center of Colorado, 2777 Mile High Stadium Circle

    Denver, Colorado, 80211

  • First Urology PSC, 101 Hospital Boulevard

    Jeffersonville, Indiana, 47130

  • Providence Regional Cancer System

    Lacey, Washington, 98503

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Clinical Research Solutions PC

    Middleburg Heights, Ohio, 44130

  • Urology San Antonio Stone Oak, 18915 Meisner Drive

    San Antonio, Texas, 78258-4223

  • Urologic Surgeons of Washington

    Washington D.C., District of Columbia, 20036

Other trials in United States

Russia7 sites

  • Altay Regional Oncology Center

    Barnaul, 656045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Federal State Institution Medical Radiology Research Center

    Obninsk, 249036

  • Clinical Oncology Dispensary

    Omsk, 644013

  • First St. Petersburg State Medical University n.a. I.P Pavlov

    Saint Petersburg, 197022

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, 197758

  • Hospital Orkli LLC

    Saint Petersburg, 199178

Other trials in Russia

France6 sites

  • Centre Jean Bernard Clinique Victor Hugo

    Le Mans, 72000

  • CHRU Lille

    Lille, 59037

  • Centre Léon Berard

    Lyon, 69008

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital d'Instruction des Armées de Begin

    Saint-Mandé, 94160

  • Hopital Foch

    Suresnes, Hauts-de-Seine, 92151

Other trials in France

Spain6 sites

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Malaga - Hospital Civil

    Málaga, 29009

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Poland5 sites

  • Onko-Centrum Sp. z o.o.

    Lublin, 20-250

  • NZOZ Centrum Urologiczne Sp zoo

    Mysłowice, Silesian Voivodeship, 41-400

  • Clinical Research Center Spolka z Ograniczona

    Poznan, Greater Poland Voivodeship, 60-848

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, 08-110

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Finland4 sites

  • Helsinki University Hospital Comprehensive Cancer Center - PPDS

    Helsinki, 00290

  • Oulun Yliopistollinen Sairaala

    Oulu, 90220

  • Seinäjoen Keskussairaala

    Seinäjoki, 60220

  • Tampereen yliopistollinen sairaala

    Tampere, 33521

Other trials in Finland

Germany4 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Urologische Studienpraxis

    Nürtingen, Baden-Wurttemberg, 72622

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • UroGynZentrum Wall

    Wuppertal, 42103

Other trials in Germany

Netherlands4 sites

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

  • Antonius Ziekenhuis

    Sneek, Provincie Friesland, 8601 ZK

  • Hagaziekenhuis

    The Hague, South Holland, 2545 AA

Other trials in Netherlands

United Kingdom4 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Diana Princess of Wales Hospital

    Grimsby, South Humberside, DN33 2BA

  • Royal Marsden Hospital - London

    London, SW3 6JJ

  • Mount Vernon Hospital

    Northwood, HA6 2RN

Other trials in United Kingdom

Australia3 sites

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Affinity Clinical Research

    Nedlands, 6009

  • Icon Cancer Care Gold Coast

    Southport, Queensland, 4215

Other trials in Australia

Canada2 sites

  • Fe/Male Health Centre

    Oakville, Ontario, L6H 3P1

  • CIUSSS de l'Estrie-CHUS

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

Denmark2 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Italy2 sites

  • Azienda Ospedaliera S Maria Di Terni

    Terni, Umbria

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126

Other trials in Italy

Austria1 site

  • Kepler Universitätsklinikum Linz

    Linz, 4020

Other trials in Austria

About this study

Official 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)

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.

Read the detailed description

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). Patients must not have been previously treated with next generation AR-Inhibitors or Androgen-biosynthesis Inhibitors, or prior progression on ketoconazole.

The following assessments 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. Radiographic disease progression is defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease, or the appearance of two or more new bone lesions on bone scan.

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 pre-dose on Day 1 and prior to dosing on Days 8 (Week 2), 15 (Week 3) and 22 (Week 4), 29 (Week 5), 57 (Week 9), 85 (Week 13) and Day 169 (Week 25). Blood samples for calculating a 24 hour pharmacokinetic profile of HC-1119 and enzalutamide and related metabolites will be collected in a subset of 24 Caucasian (non-Chinese) patients on Day 1 and at steady state in week 9.

Patients will have a safety follow-up visit 30 days after their last dose of study drug or prior to initiation of any new therapy, or an investigational agent, whichever occurs first.

Being tested
HC-1119, Enzalutamide
Keywords
HC-1119, enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HC-1119Drug

    oral once daily 80 mg

  • EnzalutamideDrug

    oral once daily 160 mg

Study groups in NCT03850795
Study groupRoleWhat they receive
HC-1119ExperimentalOral dose of 80 mg/day
Receives: Drug: HC-1119
enzalutamideActive comparatorOral dose of 160 mg/day
Receives: Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by RECIST 1.1.

    Measured: Week 24

Secondary outcomes (4)

  1. PSA decline of ≥50% from baseline

    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by decline of ≥50% from baseline

    Measured: Week 24

  2. Radiographic Progression-free Survival (rPFS)

    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by radiographic progression-free survival (rPFS)

    Measured: Week 24

  3. Overall Survival (OS)

    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS)

    Measured: Week 24

  4. Safety and Tolerability (based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0)

    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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start15 Mar 2021
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

Why it stopped: Terminated by Sponsor for various factors including prolonged duration and enrollment challenges

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850795
Sponsor's protocol ID
HC1119-CS-03
Status last verified
Aug 2024
First submitted
20 Feb 2019
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HC-1119 and Enzalutamide in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Hinova Pharmaceuticals USA, Inc. at 58 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Russia, France, Spain, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated by Sponsor for various factors including prolonged duration and enrollment challenges). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.

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