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Antiandrogen

HC-1119 vs Enzalutamide for Advanced Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Hinova Pharmaceuticals USA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Bone disease progression defined by PCWG3 with two or more new lesions on bone scan.
Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study Summary

This trial is a study to compare the effectiveness and safety of a new oral medication, HC-1119, to a current standard of care medication, enzalutamide, in men with asymptomatic or mildly symptomatic prostate cancer that has progressed despite treatment with prior hormone therapy.

Who is the study for?
Men with advanced prostate cancer that's resistant to hormone therapy and hasn't spread to the brain. They must have a low testosterone level, show signs of cancer growth despite treatment, and be in good physical shape. No recent chemo, major surgery, or other prostate cancer treatments are allowed. Participants need effective birth control if applicable.Check my eligibility
What is being tested?
The trial is testing HC-1119 against Enzalutamide in men with metastatic castration-resistant prostate cancer who have mild symptoms or none at all. It's a Phase 3 study where patients randomly get either HC-1119 (80 mg/day) or Enzalutamide (160 mg/day), both taken orally.See study design
What are the potential side effects?
Possible side effects include reactions related to heart health, fatigue, changes in blood tests reflecting organ function, potential for seizures especially for those predisposed, gastrointestinal issues affecting drug absorption and general discomfort from medication intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bone scan shows two or more new lesions, indicating my cancer has progressed.
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I am currently undergoing hormone therapy for cancer.
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I have not had chemotherapy for prostate cancer.
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My prostate cancer symptoms are mild or non-existent.
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My prostate cancer is confirmed without certain aggressive features.
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I am sexually active and use a condom plus one other birth control method.
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I plan to continue hormone therapy for my cancer throughout the trial.
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I am unable to father children, or my female partner cannot become pregnant.
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My cancer has spread, and it can be measured by scans.
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I use a barrier method with spermicide for contraception.
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My PSA levels have been rising and are now above 2 ng/mL.
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My cancer has worsened while on hormone therapy.
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I am 18 or older and can consent to treatment.
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I have been on a stable dose of bisphosphonate or denosumab for at least 4 weeks.
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I am fully active or can carry out light work.
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I can swallow pills and follow the study's rules.
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I am a male who will use a condom during sex with a pregnant partner while on the study drug and for 3 months after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Overall Survival (OS)
PSA decline of ≥50% from baseline
Radiographic Progression-free Survival (rPFS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HC-1119Experimental Treatment1 Intervention
Oral dose of 80 mg/day
Group II: enzalutamideActive Control1 Intervention
Oral dose of 160 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HC-1119
2017
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Hinova Pharmaceuticals USA, Inc.Lead Sponsor

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03850795 — Phase 3
Prostate Cancer Research Study Groups: HC-1119, enzalutamide
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT03850795 — Phase 3
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850795 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other peer-reviewed articles that have been published on HC-1119?

"HC-1119 is being investigated in 103 separate ongoing studies, 30 of which have progressed to Phase 3. Many of the trials taking place in Germantown, Tennessee, but there are 5748 total sites where HC-1119 trials are being conducted."

Answered by AI

What is the projected size of the study pool?

"In order to run this study, we need 430 willing and eligible participants. If you meet the requirements and are interested, you can visit First Urology PSC in Jeffersonville, Indiana or Urology Center of Colorado in Denver, Colorado."

Answered by AI

Is HC-1119 considered a high-risk compound?

"The team has given HC-1119 a safety score of 3 out of 3. This is due to the fact that it is a Phase 3 trial, meaning there is existing data that suggests the drug is effective and multiple rounds of data that support its safety."

Answered by AI
~10 spots leftby Jul 2024