prostate cancer
Conditions
Interventions
Case series:autologous RAK cell
Sponsors
Beijing Hospital, National Center of Gerontology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosed as prostate cancer by histological examination, currently diagnosed as metastatic castration resistant prostate cancer (mCRPC); 2. With or without measurable lesions (according to RECIST 1.1); 3. Patients with metastatic castration-resistant prostate cancer who progressed after abiraterone treatment and after chemotherapy; patients with metastatic castration-resistant prostate cancer who progressed after treatment with abiraterone and who refused chemotherapy; metastatic Patients with castration-resistant prostate cancer who refuse to undergo abiraterone and chemotherapy; progression including imaging progression and/or PSA progression* *Standard for PSA progression: The PSA value is more than 25% of the lowest value in the previous treatment, and the absolute value is higher than the lowest value = 2 ng/ml, and is confirmed after 3 weeks. *Standards for imaging progression: Soft tissue lesions were evaluated for tumor progression according to RECIST criteria, or bone scans suggested the presence of two or more new lesions (according to the PCWG3 criteria). 4. Aged 18 to 85 years; ECOG PS score: 0~2 points; expected survival time is more than 3 months; 5. From the previous treatment end time = 4 weeks, these treatments include new endocrine therapy drugs (abiraterone, enzalutamide), cytotoxic drugs, radiotherapy, surgery and other treatments for metastatic prostate cancer; 6. The main organ function is basically normal, that is, the following criteria are met: (1) Blood routine examination standards must meet: HB=90g/L (no blood transfusion within 14 days); WBC=3.0×10^9/L; PLT=80×10^9/L (2) Blood biochemical tests must meet the following criteria: TBIL = 1.5 times the upper limit of normal (ULN); ALT and AST = 2.0 times ULN; if there is liver metastasis, ALT and AST = 5 times ULN; Cr = 1.25 times ULN or creatinine clearance (CCr) = 60ml / min; (3) Assessment of cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) = normal low limit (50%). 7. Patients voluntarily joined the study, signed informed consent, and were well compliant.
Exclusion criteria
Exclusion criteria: 1. Previously used anti-angiogenic targeted drug therapies for metastatic castration against prostate cancer, such as cabozantinib, sunitinib, sorafenib, etc. 2. There are any patients who are severe and/or fail to control the disease, including: (1) patients with blood pressure control by the maximum antihypertensive treatment are still not ideal (systolic blood pressure > 160mmHg, diastolic blood pressure > 100mmHg) patients; angina pectoris and cerebral ischemia history in the past 3 months. (2) serious infections that are active or uncontrollable; (3) liver diseases such as decompensated liver disease, chronic active hepatitis, etc.; (4) poor diabetes control (fasting blood glucose (FBG)> 10mmol / L); (5) urine routines suggest that urine protein = ++, and confirmed 24-hour urine protein quantitation > 1.0 g; 3. Long-term unhealed wounds or fractures; 4. Patients with bleeding tendency (such as active gastrointestinal ulcers) or who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or the like; 5. Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 6. Patients who have participated in other clinical trials of anti-tumor drugs within four weeks; 7. Have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 8. According to the investigator's judgment, there are serious concomitant illnesses that endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without PSA progression;Survival without image progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in PSA;Overall survival; | — |
Countries
China
Contacts
Public ContactMing Liu
Beijing Hospital, National Center of Gerontology
Outcome results
None listed