castration resistant prostate cancer
Conditions
Interventions
Intervention group 1:novel hormonal therapy
Control group 1:Docetaxel chemtherapy
Intervention group 2:novel hormonal therapy+immunotherapy
Control group 2:novel hormonal therapy/docetaxel chemotherapy
Intervention group 3:Docetaxel plus carboplatin chemotherapy
Control group 3:Docetaxel chemotherapy + precision medicine / docetaxel chemical therapy
Intervention group 4:Docetaxel plus carboplatin chemotherapy + precision medicine / Docetaxel plus carboplatin chemotherapy + novel hormonal therapy
Control group 4:Docetaxel plus carboplatin chemotherapy
Sponsors
The Second Hospital of Tianjin Medical University, Tianjin, China
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with CRPC after various laboratory indicators and imaging examination methods; 2. Written informed consent form; 3. A male aged 18 years; 4. ECOG 2 points, patients with no blood system disease (aplastic anemia, leukemia, etc.), did not affect the drug absorption of gastrointestinal diseases, no serious cardiovascular disease (persistent hypokalemia, 3 months of acute heart failure, 3 months of acute myocardial infarction, etc.), no affect the swallowing function of the nervous system disease (cerebral hemorrhage or cerebral infarction caused eating difficulties, etc.); 5. Patients have good compliance and receive regular review plan to our hospital (review of liver function and electrolyte within 1 month; PSA within 1~2 months; and imaging examination within 2~4 months: at least including whole-body bone imaging and prostate MRI examination; increasing laboratory examination frequency and imaging content according to the patient's own reaction and treatment condition); 6. The obtained tumor tissue samples were immunohistoically stained and at least one molecular marker was positive; 7. According to the requirements of clinical trials, the patient's own conditions and treatment willingness, he is willing to accept the molecular typing according to the 8 molecular markers, and he is willing to accept the subsequent treatment plan; 8. The laboratory tests meet the following criteria: 1) Hemoglobin: 9.0 g/dL, Absolute neutrophil count of 1.5109 / L, Platelet count of 100109 / L (at screening, Within 4 weeks prior to obtaining the laboratory blood samples, Subjects must not receive any growth factor therapy, Or shall not receive blood transfusion within 7 days before obtaining the samples); 2) Total bilirubin (TBIL) level is 1.5 times the upper limit of normal value (ULN); 3) Alanine aminoaminase (ALT) and aspartate aminoaminase (AST) levels of 2.5 ULN); 4) Serum creatinine (SCr) level is 1.5 ULN; 9. The expected survival period was 6 months.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot confirm CRPC after various laboratory indicators and imaging examination methods; 2. Patients are known to exist or suspected brain tissue metastasis, and even had epilepsy, causing brain diseases such as dysphagia, previously affect absorption function and clinically significant gastrointestinal diseases, history of acute myeloid leukemia or myelodysplasia syndrome, serious liver dysfunction (albumin 2.5ULN, etc.), serious hypokalemia, and clinical manifestations, patients serious water and sodium retention, and even acute heart failure, ECOG 3 points; 3. Patients have very poor compliance performance, do not cooperate with the treatment, irregular use of drugs, unauthorized change of the treatment plan, can not be regularly reviewed; 4. Excluding immunohistochemical staining of tumor tissue samples, all molecular markers had negative results and still negative expression after secondary restaining; 5. Patients who cannot accept the corresponding treatment plan according to the test plan according to the molecular subtyping according to the clinical trial method, the patient's physical condition and the patient's diagnosis and treatment intention; 6. Patients who are contraindicated to CT and MRI contrast agents and cannot complete the follow-up review; 7. Known to be allergic to any study drug, similar drug, or excipients of the study drug preparation; 8. Active viral hepatitis, a known human immunodeficiency virus infection with a detectable viral load, or a chronic liver disease requiring treatment; 9. Any other serious or unstable disease or medical, social or psychological condition that may compromise subject safety and / or affect their trial procedures compliance, or may hinder subject participation or hinder the evaluation of the study findings; all these patients will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;psa-progress-free survival;radiology progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA reaction rate; | — |
Countries
China
Contacts
Public ContactYong Wang
The Second Hospital of Tianjin Medical University, Tianjin, China
Outcome results
None listed