Metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Interventions
Group A(control group):ADT+Enzalutamide
Group B(Experimental group 1):ADT+ Enzalutamide +NK cells
Group C(Experimental group 2):ADT+ Enzalutamide +NK cells+ PD-1
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Subject who is diagnosed as mCRPC and had standard treatment (Docetaxel chemotherapy or at least one kind of neoadjuvant hormonal therapy) but failed to recover; b. Histopathologically diagnosed as prostate acinar adenocarcinoma , could be accompanied by ductal adenocarcinoma or intraductal carcinoma; c. Subject must participate and sign an informed Consent form Voluntarily, age = 18 years old.; d. ECOG score is 0-1; e. Subject with good organ functions, which should be measured by the following laboratory tests ( results need be obtained =7 days before enrollment); 1) Neutrophil absolute count =1.5×10^9/L, platelets =100×10^9/L, hemoglobin =90g/L; 2) International Normalized Ratio(INR) or Activated Partial Thromboplastin Time(APTT) =1.5× upper limit of normal range; 3) Calculated creatinine clearance=45ml/min; 4) Serum total bilirubin =1.5× upper limit of normal range; 5) AST, ALT and alkaline phosphatase =2.5× upper limit of normal value; f. Fertile subject must use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: a. Pathologically diagnosed as neuroendocrine carcinoma or small cell carcinoma of the prostate; b. Poor physical condition and unable to tolerate treatment with the study regimen; c. Active autoimmune disease or a history of autoimmune disease that may recur; d. Active hepatitis; e. A history of severe allergies; f. Poorly controlled diabetes, hypertension, abnormal laboratory results with potassium, sodium, or corrected calcium > grade 1 after standard treatment, or grade =3 hypoalbuminemia within 14 days prior to enrollment; g. A history of HIV infection; h. Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to enrollment; i. The left ventricular ejection fraction is known to be < 40%; j. Subject who had allogeneic stem cell transplantation or organ transplantation prior to enrollment; k. Toxic side effects which caused by previous anti-cancer treatment have not returned to baseline or stable levels. Unless the adverse event is not considered to pose a potential safety risk (e.g. hair loss, neuropathy, and specific laboratory abnormalities); l: There is an underlying medical condition, alcohol/drug abuse or dependence that the investigator considers to be detrimental to study implementation or likely to affect treatment-related adverse events. Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Progression Free Survival (rPFS);Prostate specific antigen (PSA) - Progression-Free Survival (PFS);Overall Survival; | — |
Countries
China
Contacts
Public ContactNing Zhang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed