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Tests treatment safety and results for MCRPC
Official title A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
ClinicalTrials.gov ID: NCT03851640
What this study is testing
What is HC-1119?
HC-1119 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mcrpc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.
- people with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.
- In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determined...
- PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg/L (1 ng/mL) in the screening period;
- Progression of soft tissue lesions as defined by RECIST 1.1;
You likely can't join if
- people with any of the following conditions should not be enrolled:
- Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen...
- Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).
- Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT/MRI scan of...
- Patients with known serious cardiovascular diseases, including any of the following:
- A myocardial infarction or thrombotic event occurred in the past 6 months;
See the full eligibility criteria
Who can join
- Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.
- people with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.
- In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determined according to the PCWG3 criteria, defined as satisfying one or more of...
- PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg/L (1 ng/mL) in the screening period;
- Progression of soft tissue lesions as defined by RECIST 1.1;
- The progression of bone lesions is defined as at least two new lesions discovered by bone scan; ambiguous results can be confirmed using another imaging technique (e.g., CT or MRI).
- Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed by bone scan and/or CT/MRI scan).
- For patients who have undergone orchiectomy or are being treated by medical castration therapy, their androgen blockade therapy is maintained by luteinizing hormone-releasing hormone agonists or antagonists during the...
- Patients who have failed previous treatments of prostate cancer with abiraterone acetate or who are intolerant to treatments with abiraterone acetate.
- Patients who have failed previous chemotherapy of prostate cancer with docetaxel or who are intolerant to treatments with docetaxel, or who are not suitable for docetaxel treatment during screening. Patients who are not...
- Expected survival of ≥ 3 months.
- ECOG performance status score of 0-2.
- Laboratory tests must meet the following criteria:
- Blood routine examination: Hemoglobin (Hb) ≥ 85 g/L; white blood cell (WBC) ≥ 3.0 x 109/L; platelet (PLT) ≥ 75 x 109/L;
- Liver function: Total bilirubin (TBIL) ≤ 1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (for patients without liver metastasis) or ≤ 5 x ULN (for patients with liver...
- Renal function: serum creatinine (SCr) ≤ 1.5 x ULN.
- Willing to use reliable contraceptive measures (such as condoms) and not to donate sperms throughout the study period and within 3 months after the last dose.
What rules you out
- people with any of the following conditions should not be enrolled:
- Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiotherapy, treatments with...
- Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).
- Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT/MRI scan of the head is required)
- Patients with known serious cardiovascular diseases, including any of the following:
- A myocardial infarction or thrombotic event occurred in the past 6 months;
- Known unstable angina;
- Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;
- QT interval of \> 500 ms during screening visits;
- Resting systolic blood pressure of \>170 mmHg or diastolic blood pressure of \>105 mmHg suggesting uncontrolled hypertension during screening visits.
- The toxicity of previous treatment has not been eliminated before the start of the study treatment; toxic reaction of grade 2 or above (except for hair loss) according to the CTCAE 5.0 grading scale remains.
- Clinically significant gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (for example, inability to swallow, chronic diarrhea or intestinal obstruction, and patients had total...
- Patients with a history of serious diseases in the central nervous system. Patients with a history of epilepsy or any history of diseases that may induce epilepsy, including unexplained loss of consciousness or...
- Patients who have been diagnosed in the past 5 years with other malignant tumors in addition to prostate cancer, except patients with cured basal or squamous cell skin cancer and superficial bladder tumors (Ta, Tis, and...
- Patients with a history of allogeneic bone marrow or organ transplantation who require continued medical treatment.
- Patients with known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis or other active infections.
- Patients known to be allergic to androgen receptor inhibitors.
- The investigator believes that the patients are unfit for this study (e.g., the treatments will not benefit the patients the most, inadequate patient compliance, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.