prostate cancer
Conditions
Interventions
Experimental group:bipolar androgen therapy sequential enzalutamide and immune checkpoint (PD-1) inhibitors
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Metastatic prostate cancer, Gleason score >=7; 2. Diagnosis of castration-resistant prostate cancer (CRPC) : (1) Serum testosterone reached castration level (2ug/L; Or imaging progress: bone scan revealed 2 or more new lesions or enlarged soft tissue lesions that met the evaluation criteria for solid tumor response; 3. Aged 18 to 85 years; 4. Patients who failed chemotherapy or could not receive chemotherapy or were unwilling to receive chemotherapy after the failure of new endocrine therapy; 5. No obvious pain symptoms (NRS=90g/L, white blood cells >=3.5x10^9/L, neutrophils >=1.5x10^9/L, platelets >=100x10^9/L; (2) Creatinine <=1.0x upper limit of normal (UNL); The creatinine clearance rate was greater than 60ml/min; (3) Alanine aminotransferase (ALT) <=1.5x upper normal limit (UNL); Aspartate aminotransferase (AST) <=1.5x upper limit of normal (UNL); Alkaline phosphatase (ALP) <=1.5x upper limit of normal (UNL); (4) Total bilirubin (TBIL) <=1.5x the upper limit of normal (UNL); 8. Can regularly cooperate with treatment and follow-up; 9. The life expectancy of enrolled cancer patients should not be less than 4 months; 10. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received BAT treatment in the past; 2. Previous treatment with immune checkpoint inhibitors; 3. Patients with high risk bone lesions: bone scan nuclide aggregation, pathological fracture of femur or spinal metastasis or spinal cord compression risk; 4. Complicated with the following diseases: autoimmune diseases, infectious diseases (HIV, HBV, HCV), severe cardiovascular and cerebrovascular diseases (previous history of myocardial infarction and cerebral infarction), thrombus related diseases, interstitial pneumonia; 5. Patients with metastatic prostate cancer who need opioids for pain relief; 6. More than 5 metastatic lesions in lung or liver (non-specific nodules <=1 cm in lung are not counted); 7. Patients with hypersensitivity to the active ingredient of enzulamide or triprilimab and any of the listed excipients should be excluded; 8. Participating in other clinical trials; 9. Patients with a history of mental illness or poor compliance or who are considered unsuitable for this study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate-specific antigen (PSA) response rate at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival without biochemical recurrence;Overall survival;Objective remission rate;QOL symptom relief rate;Comparison of pain scores after treatment; | — |
Countries
China
Contacts
Public ContactLiu Ming
Beijing Hospital
Outcome results
None listed