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This trial aims to prospectively assess the safety and efficiency of SHR7390 in metastatic castration-resistant prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | SHR7390 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7390 | Drug | SHR7390 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The percentage of patients with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria | 2 years |
| AE | The type, frequency, severity, timing, seriousness, and relationship to study therapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate | After the continuous therapy from randomisation to the end of the 12 weeks, the percentage of patients whose levels of PSA decreased by more than 50% compared with baseline | 2 years |
| Time to prostate specific antigen (PSA) progression |
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Inclusion Criteria:
Patients aged 18-75 years,male
ECOG PS:0-1
Life expectancy of more than 6 months
After surgery or drug castration, testosterone level was < 50 ng / dl. For subject receiving LHRH agonist / antagonist therapy (patients without orchiectomy), the treatment must start at least 4 weeks before the first day of cycle 1 and must be continued throughout the study
Failure (radiological or PSA progression) or intolerance of at least one but not more than two taxanes based chemotherapy regimens and novel endocrine therapy (at least one of enzalutamide, apartamide, abitelone or shr3680). If docetaxel regimen used more than once, count as one regimen
Disease progressed within 6 months prior to inclusion in the study. Disease progression defined as the occurrence of one or more of the following three items at the same time of castration:
①PSA progression,defined as at least twice increases in PSA level (interval time ≥ 1 week, and PSA level at screening should be ≥ 2ng / ml)
â‘¡Disease progression as defined in RECIST 1.1
③Bone disease progression defined by PCWG3,more than 2 new lesions in bone scan
Metastatic lesions with radiologica evidence, measurable non-bone target lesions
Adequate hepatic, renal, heart, and hematologic functions (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before blood routine screening):platelets>80×10^9/L,neutrophil>1.5×10^9/L, Hb≥90 g/L,total bilirubin≤1.5×limit of normal(ULN), ALT and AST ≤2.5×ULN(≤5×ULN with liver metastasis),blood urea nitrogen and creatinine≤1.5×ULN
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
Willing to participate in this clinical trial, understand the research procedures and have signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo | Department of Urology, Drum Tower Hospital, Medical School of Nanjing University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210000 | China |
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Time from randomisation to the first time of PSA progression according to the criterion of PCGW3 |
| 2 years |
| Radiographic Progression Free Survival(rPFS) | Time from randomisation to radiologically confirmed progressive disease or death due to any cause | 2 years |
| OS | Time from randomisation to death due to any cause | 2 years |
| DoR | Time from radiologically confirmed reponse to radiologically confirmed progressive disease or death | 2 years |
| Time to skeletal-related events | Time from randomisation to the first occurrence of a skeletal-related event. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery | 2 years |