Status:
NOT_YET_RECRUITING
Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
Lead Sponsor:
Jianbin Bi
Conditions:
Metastatic Hormone-Sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients...
Detailed Description
This is a multicenter, prospective, cohort study to observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in patients with hormone-sensitive prostate cancer who hav...
Eligibility Criteria
Inclusion
- Age ≥ 18 years; male;
- Patients with pathological detection of prostate cancer and clinical diagnosis of metastatic hormone-sensitive patients with bone scanning, electronic computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET-CT) and other imaging examinations;
- Patients with mHSPC are allowed to use other novel endocrine or systemic regimens in the pre-order (excluding those treated with chemotherapy alone or bicalutamide), castration with an ongoing gonadotropin-releasing hormone analogue (GnRHa) (drug castration), or prior bilateral orchiectomy (surgical castration); Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period;
- PSA progression at enrollment: for patients who respond to initial therapy, PSA progression is determined if serum PSA exceeds 25% of the minimum PSA during treatment and \> 0.4 ng/mL in absolute terms, and after repeated confirmation 3 weeks after the elevation is found; for patients with persistent PSA elevation after initial treatment, PSA progression is determined when the PSA elevation exceeds 25% of the baseline value and the absolute value is\>0.4 ng/mL at 12 weeks of treatment;
- The Eastern Cooperative Oncology Group（ECOG）PS of 0 or1;
- The main organ indicators such as blood routine, coagulation function, liver and kidney function, and heart function are normal:
- ANC≥1.5×109/L；
- PLT≥100×109/L
- Hb≥90g/L；
- TBIL≤1.5×ULN；
- ALT and AST≤2.5×ULN；
- BUN（or UREC）和Cr≤1.5×ULN；
- LVEF≥50%； Volunteer to participate in this clinical trial, understand the research procedure, and have signed an informed consent form
Exclusion
- Failure to sign an informed consent form;
- Patients with allergic reactions to the pharmaceutical ingredients or excipients used in the study;
- Patients with difficulty swallowing or poor digestion and absorption function；
- Patients with severe liver function impairment (Child Pugh C grade)；
- Confirmed by imaging, there is a brain tumor lesion; Having a history of epilepsy, or having a disease that can trigger seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization);
- Active heart disease within the first 6 months of C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication;
- Suffering from any other malignant tumor within the first 5 years of C1D1 (excluding fully remitted in situ cancer and malignant tumors that have been determined by the researchers to progress slowly);
- Have a history of immunodeficiency (including HIV testing positive, other acquired or congenital immunodeficiency diseases) or a history of organ transplantation;
- Subjects who are unwilling to take effective contraceptive measures during the entire study treatment period and within 30 days after the last administration;
- According to the judgment of the investigator, there are concomitant diseases (such as poorly controlled hypertension, serious diabetes, neurological or mental diseases, etc.) or any other conditions that seriously endanger the safety of patients, may confuse the research results, or affect the completion of the study by the subjects;
- Patients participating in other clinical trial studies; After evaluation by the researcher, any other circumstances deemed unsuitable for participation in this study.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06134271
Start Date
November 15 2023
End Date
April 30 2026
Last Update
November 18 2023
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