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HC-1119 vs Enzalutamide for Advanced Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have not had radionuclide therapy for metastasis in the last 4 weeks.My bone scan shows two or more new lesions, indicating my cancer has progressed.I have a stomach or intestine condition that affects how my body absorbs food.My kidney function is low, with a creatinine clearance below 30 mL/min.I have previously used medications or participated in a study for drugs that affect hormone levels.I have not taken finasteride, dutasteride, or estrogens in the last 4 weeks.My blood counts are low and I haven't had treatments to increase them in the last 14 days.I haven't had systemic biologic therapy for prostate cancer in the last 4 weeks.I have not taken bicalutamide or nilutamide in the last six weeks.I have not had major surgery in the last four weeks.I am currently undergoing hormone therapy for cancer.I have not had chemotherapy for prostate cancer.My prostate cancer symptoms are mild or non-existent.I have a serious heart condition.You have taken any experimental medication within the past four weeks before starting the study.My prostate cancer is confirmed without certain aggressive features.I am sexually active and use a condom plus one other birth control method.I plan to continue hormone therapy for my cancer throughout the trial.I am unable to father children, or my female partner cannot become pregnant.I have active tuberculosis.I haven't used certain herbal products or high-dose steroids recently.I have been using painkillers daily for prostate cancer pain for the last 4 weeks.My cancer has spread, and it can be measured by scans.I use a barrier method with spermicide for contraception.My PSA levels have been rising and are now above 2 ng/mL.My cancer has worsened while on hormone therapy.I do not have brain metastasis or active leptomeningeal disease.I am 18 or older and can consent to treatment.I have been on a stable dose of bisphosphonate or denosumab for at least 4 weeks.I have not taken flutamide in the last four weeks.I am fully active or can carry out light work.I can swallow pills and follow the study's rules.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.I have received radiation for my primary tumor within the last 3 weeks.I have not had any cancer other than non-melanoma skin cancer in the last 2 years.I am not taking any strong medication that affects liver enzymes or heart rhythm.I have a rare genetic issue with fructose due to sorbitol.I have a history of seizures or conditions that could lead to seizures.You have conditions that make you more likely to fall or break bones, as determined by the doctor in charge of the study.
- Group 1: HC-1119
- Group 2: enzalutamide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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