Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring metastatic castration-resistant prostate cancer, dendritic cell vaccine Read More

Inclusion Criteria：

• Histologically prostate adenocarcinoma, exclusion of the initially diagnosed neuroendocrine or small-cell carcinoma.
• Subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel androgen-deprived therapy and docetaxel chemotherapy. The previous antitumor treatment is ≥4 weeks prior to first dose.
• The previous clinical trials is ≥30 days prior to screening; Under the circumstance of previous clinical trials≤3 months , the pre-trial drug cannot interfere the safety and efficacy of current trial judged by the investigators.
• Age ≥18 years old when signing ICF, male, weight ≥50kg.
• Screening ECOG performance status is ≤2.
• Written information consent provided prior to the initiation of study procedures with cooperation during the follow-up.

Exclusion Criteria:

• Treatment requirement of Olaparib with the confirmed BRCA gene mutation.
• Rechallenge of docetaxel or other chemotherapy.
• Imminent Radiotherapy with radium-223.
• Plan to participate in other clinical trials.
• Pathological long bone fracture (cortical erosion > 50% on imaging) or spinal cord compression.
• History of other malignancies in the past 5 years with the exception of the following：cancer disease free≥5 years or squamous or basal cell skin carcinoma.
• Systemic therapy of immunosuppressive agents (such as cyclosporine, tacrolimus, rapamycin, and azathioprine, etc.) within one month prior to screening.
• Use of oral, intramuscular or intravenous corticosteroids within 28 days prior to enrollment. Short-term use of corticosteroids are allowed to prevent reactions for imaging studies. Use of inhaled corticosteroids for breathing insufficiency (chronic obstructive pulmonary disease) and topical steroids are allowed.
• Positive infectious disease screening. Active HBV hepatitis (defined as positive HBsAg with HBV-DNA ≥ upper limit of normal （ULN））; Active hepatitis C (defined as HBV-Ab ≥ULN)； Positive COVID-19；Human immunodeficiency virus (HIV) infection with HIV-Ab ≥ULN；Positive syphilis with TP-Ab≥ULN.
• Myocardial infarction, unstable angina pectoris, cardiac surgery or interventional therapy within 6 months prior to enrollment. Congestive heart failure, atrial fibrillation or other poorly controlled arrhythmias.
• Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attack), craniocerebral surgery and unexplained loss of consciousness occurred within 6 months before enrollment.
• Presence of the malignant pleural effusion or malignant ascites.
• History of severe allergic reactions or allergies to the ingredients of Prodencel.
• Abnormal screening hematologic function: white blood cell count (WBC)<3.0×109/L, neutrophil count (NEUT)<1.5×10^9/L, platelet count (PLT)<100×10^9/L, hemoglobin (Hb)< 100g/L.
• Abnormal screening coagulation function: prothrombin time (PT) ≥ULN, international normalized ratio (INR) ≥ULN, thrombin time (TT) ≥ULN.
• Abnormal screening liver and kidney function: total bilirubin (TBIL) > 1.5ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5ULN; serum creatinine (SCr) > 1.5 ULN.
• History of splenectomy.
• Presence of primary or secondary immunodeficiency disease.
• History of uncontrolled seizures, central nervous system disorders, or psychotic loss of cognition.
• History of chronic alcohol or drug abuse within 6 months prior to screening.
• Unstable systemic diseases, such as active infection, liver cirrhosis, chronic renal failure, severe chronic lung diseases, etc.
• Clinically severe pericardial effusion.
• Not suitable for leukapheresis.
• For any other reasons, the patients are believed not suitable for participation in this study by investigators.