prostate cancer
Conditions
Interventions
Immediate treatment group:Pembrolizumab
Delayed treatment group:Pembrolizumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) At least 18 years old. 2) Histologically confirmed acinar adenocarcinoma of the prostate. If the patient does not have a previous histological diagnosis, fresh baseline biopsy samples must be used to confirm the diagnosis and support biomarker analysis. 3) Metastatic hormone independent prostate cancer (mcrpc) after failed treatment with abiolone and docetaxel. 4) The testosterone level at screening time 50 ng/dl (1.73 nmol / L) was performed by surgery or drug castration and must be maintained throughout the study period. 5) Bone scan results show that there are metastatic lesions in bone, or CT / MRI scan results show that there are metastatic lesions in soft tissue. (patients with adenocarcinoma just below the aortic bifurcation were not eligible for inclusion). 6) In the case of castration, a progressive disease defined by one or more of the following three criteria when participating in the study: The progression of prostate specific antigen (PSA) was defined as the increase of PSA recorded at least 2 consecutive times (at least 7 days interval) higher than the reference value (measured value 1). If the third PSA measurement value is not higher than the second measurement value, the fourth PSA determination is required, and the measured value is higher than the second measurement value. The third (or fourth) confirmatory PSA determination should be performed within 4 weeks before randomization. The initial PSA value must be >= 1 µ g / L. The definition of soft tissue disease progression is Recist 1.1. There are two or more new metastatic bone lesions in whole-body radionuclide bone scan, as defined by prostate cancer working group 3 (pcwg3). 7) Bisphosphonates or dinomizumab used before are permitted but not mandatory. 8) ECOG physical status 0-2. 9) According to the researcher's evaluation, the life expectancy is more than 2 months. 10) Patients with ejaculation and sexual activity must agree to take contraceptive measures and not donate sperm from the first administration of the study treatment to four months after the last dose of the study treatment. 11) Agreed to receive treatment with pabolizumab,able to follow planned visits, treatment plans, laboratory tests and other research procedures.
Exclusion criteria
Exclusion criteria: 1) The evidence of metastasis was only in patients with adenocarcinoma below the bifurcation of aorta. 2) If cytotoxic chemotherapy (including but not limited to docetaxel), biotherapy including cisplatin-t, or radionuclide therapy for castration sensitive prostate cancer were used, but stopped within 28 days before randomization. 3) Cardiovascular diseases of clinical significance, including any of the following: Myocardial infarction or symptomatic myocardial ischemia occurred within 6 months before screening. The New York Heart Association grade III or IV congestive heart failure. Clinically significant ventricular arrhythmias (e.g., persistent ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening. A history of cardiac block of Mohr's type II, II or III degree, unless a permanent pacemaker has been implanted. 4) Significant renal dysfunction defined by any of the following laboratory abnormalities: according to the MDRD formula (see www.mdrd.com). The resulting EGFR was 1.5 times the upper limit of normal (ULN) (for patients with proven Gilbert syndrome or indirect bilirubin concentration indicating extrahepatic elevation, > 3 x ULN). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5-fold ULN (or > 5 x ULN if liver function abnormality is caused by liver metastasis). Albumin < 2.8 g / dl. 6) Absolute neutrophil count (ANC) < 1500 / L, platelet < 100000 / L or hemoglobin < 9 g /dl (in screening, growth factors or blood transfusion should not be received within 14 days before hematological laboratory examination). 7) Known or suspected brain metastases or active meningeal diseases. 8) Symptomatic or impending spinal cord compression or cauda equina syndrome. 9) Any history of myelodysplastic syndrome or acute myeloid leukemia or previous malignant tumor except: Cancer in situ or non melanoma skin cancer Before randomization, patients with cancer diagnosed and treated for more than 5 years without evidence of subsequent recurrence A stage 0 or 1 cancer defined by the Joint Commission on cancer in the United States that the probability of recurrence is minimal according to the researchers and sponsors 10) There has been a history of epilepsy or any disease that may induce epilepsy (e.g., previous cortical stroke, significant brain damage).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactXiao Wenjun
Fudan University Shanghai Cancer Center
Outcome results
None listed