Metastatic prostate cancer
Conditions
Interventions
Combination therapy group:Autologous RAK cells
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Combined treatment cohort: 18-85 years old patients with prostate cancer diagnosed by histopathological examination and metastatic HSPC or metastatic CRPC diagnosed after January 1, 2018; standard treatment cohort: 18-85 years old Metastatic HSPC or metastatic CRPC confirmed by histopathological examination. The selected cases of standard treatment were matched according to the baseline data of combined treatment cases (reference to baseline age, PSA, puncture pathology Gleason score, metastatic site, number of metastases, and treatment method). 2. Patients with mHSPC are prepared to receive or are receiving standard endocrine therapy (castration or castration combined with bicalutamide or castration combined with abiraterone); mCRPC patients are ready to receive or are receiving abiraterone or more Chemotherapeutics. Definition of mCRPC: metastatic prostate cancer whose disease still progresses after continuous endocrine therapy; progression conditions: (1) serum testosterone reaches castration level ( 2µg / L; imaging progress It refers to the increase of 2 or more new lesions or soft tissue lesions that meet the evaluation criteria of solid tumor response by whole body radionuclide bone imaging. 3. ECOG PS score: 0 ~ 2 points; expected survival time is more than 3 months; 4. >= 4 weeks from the end of prostate surgery or radiation therapy; 5. The functions of the main organs are basically normal, that is, they meet the following standards: (1) The blood test standard must meet: HB >= 90g / L (without blood transfusion within 14 days); WBC >= 3.0 * 10^9 / L; PLT >= 80 * 10^9 / L (2) The blood biochemical examination must meet the following standards: TBIL = 60ml / min; (3) Cardiac Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= low limit of normal (50%). 6. If you are a fertile man, you must agree to take effective methods of contraception from the screening to the end of the test.
Exclusion criteria
Exclusion criteria: 1. Patients with metastatic HSPC who received docetaxel chemotherapy; 2. Patients with any serious and / or uncontrolled disease, including: (1) The patients whose blood pressure control was still not ideal (systolic pressure > 160mmhg, diastolic pressure > 100mmhg) after the treatment of maximal hypotension had a history of angina pectoris attack and cerebral ischemia in the past three months. (2) Active or uncontrollable serious infection; (3) Liver diseases such as decompensated liver disease, chronic active hepatitis, etc; (4) Poor diabetes control (FBG > 10mmol / L); (5) Routine urine test showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0 G; 3. Patients with long-term incurable wounds or fractures; 4. Patients with bleeding tendency (such as active peptic ulcer) or undergoing thrombolysis or anticoagulation treatment such as warfarin, heparin or their analogues; 5. Patients who have a history of psychoactive drug abuse and are unable to quit or have mental disorders; 6. Patients who have participated in clinical trials of other anti-tumor drugs within four weeks, except non intervention research drugs within the scope of this study; 7. Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplant history; 8. According to the judgment of the researchers, there are serious hazards to the safety of patients or the accompanying diseases that affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood immune indexes ;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJie Ma
Beijing Hospital
Outcome results
None listed