AR-V7-positive metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Interventions
600mg/750mg/900mg:Drug treatment (IV)
750mg/900mg:Drug treatment (IV)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in the trial: 1) Age: 18 - 80 years, male; 2) Eastern Cooperative Oncology Group (ECOG) performance status 0 ~2 points; (see Appendix 1 Eastern Cooperative Oncology Group (ECOG) performance status score); 3) Expected survival of at least 3 months; 4) Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features; 5) AR-V7 is positive (tested by IHC) (Positive defined as a score > 2 points according to the "staining intensity combined positive cell count percentage composite score 0 - 4 system") (see Appendix 2 for details); 6) Distant metastases from prostate cancer confirmed by screening imaging (Note: Distant metastases should meet TNM staging requirements for distant metastases); 7) The presence of measurable lesions is confirmed according to RECIST v1.1 (Note: This criterion applies only to the extension period); 8) Patients who have undergone bilateral orchiectomy or are receiving medical castration and have serum testosterone levels of = 1 weeks interval and >=1 ng/mL PSA at screening); (2) Progression of soft tissue lesions occurred per RECIST 1.1 criteria; (3) Bone lesion progression is defined as the presence of at least two new lesions on bone scans, confirmed by another imaging technique (e.g., CT or MRI) for ambiguous results; 10) Patients who have previously received second-generation anti-androgen or abiraterone (including participation in clinical trials with these agents) but have failed treatment (disease progression within 6 months), or have had previous response but have relapsed thereafter [relapse definition refer to inclusion criteria 9]; or patients who cannot tolerate second-generation antiandrogens or abiraterone; (Note: Second-generation antiandrogens include: Enzalutamide, Apalutamide, Darolutamide, SHR3680, HC-1119, Proxalutamide, etc.); 11) Patients who have prior chemotherapy with cytotoxic agents (e.g., docetaxel, cabazitaxel, mitoxantrone, or estramustine) but failed; or patients who cannot tolerate cytotoxic chemotherapy; or patients who are not suitable for cytotoxic chemotherapy; 12) Organ function levels must meet the following requirements (and have not been treated with blood transfusion or hematopoietic growth factor within 2 weeks prior to the test): a) Neutrophil Count (ANC) >= 1.5 x 10^9/L; b) Platelets (PLT) >= 100 x 10^9/L; c) Hemoglobin (Hb) >= 90 g/L; d) Activated Partial Thrombin Time (APTT) = 60 ml/min (this criterion is met if any); 13) Subjects must agree to use two acceptable methods of contracep
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be enrolled in the study: 1) Received other anti-prostate cancer therapy (except castration therapy) within 4 weeks before enrollment, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiation therapy, Chinese herbal drugs with anti-tumor effect, or other tested drug therapies in interventional clinical trial; or treatment with nitrosourea or mitomycin within 6 weeks; or treatment with bicalutamide or nilutamide within 6 weeks. Or patients who completed palliative radiotherapy and surgery for bone metastases or soft tissue lesions = 14 days prior to baseline imaging (palliative radiation lesions cannot be target lesions for subsequent RECIST 1.1 assessment); 2) Subjects with bone metastases or bone-related disorders treated with bisphosphonates or denosumab and were not regularly administered the drugs within 4 weeks prior to enrollment; 3) Prior antineoplastic toxicity has not resolved prior to enrollment and still have grade >= 1 toxicity (except alopecia), according to National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE v5.0); 4) Major surgical operation was performed (the definition of major surgical operation refer to the Level 3 and Level 4 operations specified in the Administrative Measures for Clinical Application of Medical Technology, implemented on May 1, 2009) (for details, see Appendix 3 Administrative Measures for Clinical Application of Medical Technology(implemented on May 1, 2009), the surgical grade will be judged by the investigator), or not completely recovered after surgery (the risk of clinical trial participation will be judged by the investigator) within 28 days before enrollment; 5) Systemic treatment with botanical drugs (such as saw palm) or steroids that may reduce PSA levels within 4 weeks prior to enrollment, or use of such drugs during this study is planned; (Except for temporary steroid use for the prevention or treatment of allergies); 6) In the past 5 years, there have been other malignancies in addition to prostate cancer, but localised tumors that have been cured can be enrolled, such as basal or squamous cell skin cancer; 7) Clinical serious vascular diseases occurred within 6 months before enrollment, including: acute arteriovenous embolism, acute embolism arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (including myocardial infarction, unstable angina pectoris, etc.), acute cerebrovascular disease, and disseminated intravascular coagulation; 8) Severe bone injury due to tumor bone metastasis, including poor control of severe bone pain, pathological fractures of important sites or spinal cord compression that is occurred in the last 6 months, or expected to occur in the near future; 9) Known with serious cardiovascular disease, including any of the following (note: Enrollment may be considered if the following has recovered or stabilized during screening): a) Heart failure, meeting New York Heart Association (NYHA) standards III or IV; b) Uncontrolled hypertension (systolic blood pressure >= 140 mmHg, or diastolic blood pressure >= 90 mmHg after stable medical treatment); c) Supra-ventricular arrhythmia or ventricular arrhythmia that cannot be effectively controlled by therapeutic intervention; 10) Patients with known brain or central nervous system metastases; 11) Severe pulmonary diseases such as interstitia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA;Tumor imaging and survival-related assessments; | — |
Countries
China
Contacts
Public ContactQiang Wei
West China Hospital, Sichuan University
Outcome results
None listed