Metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Interventions
Test group:Vedotinumab + Enzalutamide
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male, over 18 years old at the time of signing the informed consent form. 2. The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and the expected survival period was evaluated by the researchers as =6 months. 3. Metastatic castration-resistant prostate cancer confirmed by histological or cytological examination to be prostatic adenocarcinoma (excluding small cell features) with HER2 expression (HER2 expression is defined as a HER2 immunohistochemical result of 1+, 2+, or 3+), which must simultaneously meet the following criteria: 1) Continuous treatment with a luteinizing hormone-releasing hormone agonist (LHRHa) (medical castration) or prior bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa treatment throughout the study period; 2) Serum testosterone is at castrate levels at screening (= 1.5×10?/L (1,500/mm³); - Platelets >= 80×10?/L (100,000/mm³); - Hemoglobin (Hgb) >= 9.0 g/dL (90 g/L); - Albumin level >= 3.0 g/dL; - Total bilirubin = 40 mL/min/1.73 m² (calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration equation [CKD-EPI]); - Prothrombin time and activated partial thromboplastin time <= 1.5×ULN; - Electrocardiogram: QT interval corrected by Fridericia formula (QTcF) <= 470 ms; 8. Voluntarily sign a written informed consent form and demonstrate good compliance.
Exclusion criteria
Exclusion criteria: 1. Live attenuated vaccine should be administered within 4 weeks before the first dose, or it is expected that live attenuated vaccine will be needed during the study period. 2. Those who have undergone severe surgery or are in the recovery period of severe surgery within 4 weeks prior to screening. 3. Known serious brain diseases or brain metastases. 4. Has been diagnosed with any myelodysplastic syndrome, acute myeloid leukemia or any other history of previous malignant tumors within the past two years (except for non-melanoma skin cancer or superficial urothelial carcinoma that has been radical treated). 5. Suffering from a major cardiovascular disease, including any of the following conditions: myocardial infarction occurring within 6 months prior to study enrollment; uncontrolled angina pectoris occurring within 3 months prior to study enrollment; left ventricular ejection fraction 38.5°C (for subjects with neoplastic fever, the investigator shall determine eligibility for this study), persistent or active infection; positive HIV antibody, positive HBsAg with HBVDNA copy number >= ULN of the local study center, HBV infection after treatment with HBsAg(-) HBcAb(+) and HBVDNA copy number >= ULN of the local study center, positive HCV antibody with HCV RNA >= ULN of the local study center, or active syphilis infection (excluding previous syphilis infection that has been systematically treated and is currently confirmed to be cured or stable); 14. Having congestive heart failure with New York Heart Association (NYHA) functional Class ?/?, or arrhythmia that cannot be effectively controlled despite therapeutic interventions, being at risk of QT interval prolongation or using medications known to potentially cause QT interval prolongation, or having refractory hypertension (excluding hypertensive patients whose blood pressure is controlled below 140/90 mmHg with medication); 15. Clinically severe vascular diseases that occurred within 6 months prior to the first dose of study enrollment, including acute arteriovenous embolism, acute em
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main indicators: PSA50 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary indicators: ORR, PSA90 response rate, radiographic progression-free survival;Safety indicators: Statistics on the incidence of AE/SAE and changes in laboratory examinations; | — |
Countries
China
Contacts
Public ContactZhiyu Zhang
Yantai Yuhuangding Hospital
Outcome results
None listed