Prostate cancer
Conditions
Interventions
Experimental Group:Combination therapy with Tislelizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age range: =18 years old and =80 years old; Expected lifespan: =12 weeks; Patients who have been detected with IDC-P component in the initial prostate biopsy or the second biopsy after entering the mCRPC stage; Imaging examinations confirm the presence of bone metastasis or visceral metastasis; Received first-line treatment for mCRPC (including abiraterone, enzalutamide); Patients in good general condition, with an ECOG score of 0-1; Blood routine indicators: neutrophils =1.5x10^9, platelets =100x10^9, hemoglobin =90g/L; Blood biochemistry indicators: bilirubin = 1.5 times the upper limit of normal, AST = 2.5 times the upper limit of normal; serum creatinine = 1.5 times the upper limit of normal; blood calcium concentration: =12.0 mg/dL; Coagulation function: PT = 1.5 times the upper limit of normal; No occurrence of the following diseases within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cerebrovascular accident, or transient ischemic attack, etc.; Agreement to collect tumor tissue, blood, and other specimens required for this study and to apply them to related research.
Exclusion criteria
Exclusion criteria: History or concurrent presence of malignancies other than prostate cancer; Having received other first-line treatments for mCRPC (including docetaxel, cabazitaxel, apalutamide, darolutamide, olaparib, etc.); Known or suspected allergy to the study medication; Those who have received research treatments other than this study within 4 weeks before enrollment and during the study; Personal history of other malignancies with different primary sites or histology within 5 years, except for well-controlled thyroid cancer, skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ; Central nervous system metastasis and/or carcinomatous meningitis. Patients who have received treatment for brain metastasis may be included if they meet the following conditions: stable condition for at least 6 months; no evidence of disease progression on imaging within 4 weeks before the first administration of this trial; all neurological symptoms have returned to baseline; no new or active brain metastases; the patient has stopped radiation, surgery, or steroid treatment at least 4 weeks before the first administration of this trial. It should be noted that patients with carcinomatous meningitis are not eligible even if clinically stable; Active autoimmune diseases requiring systemic treatment in the past 2 years (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants); subjects using replacement therapies (e.g., thyroxine, insulin, or physiological replacement of glucocorticoids due to kidney or pituitary defects) are allowed to participate in this study; Having received allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; Having other uncontrolled serious diseases, including but not limited to: ? active or poorly controlled severe infections, such as active or persistent urinary tract infections in the past month; ? HIV-infected individuals (HIV antibody positive); ? patients with acute or chronic active hepatitis B (HBsAg/HBcAb positive and HBV DNA > 500 IU/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA > 15 IU/mL); ? active pulmonary tuberculosis, etc.; Other acute or chronic diseases, metabolic disorders, mental illnesses, abnormal physical examination results, or abnormal laboratory test values that may increase the risk associated with study participation or administration of study medication, or interfere with the interpretation of study results, and disqualify the patient from participating in this study according to the researcher's judgment; Poor patient compliance or difficulty in determining compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate specific antigen - progression-free survival, PSA-PFS;Radiographic Progression Free Survival, rPFS;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate specific antigen; | — |
Countries
China
Contacts
Public ContactPengfei Shen
West China Hospital, Sichuan University
Outcome results
None listed