prostate cancer
Conditions
Interventions
experimental group:docetaxel+carboplatin
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2. Aged >=18 years; 3. Histologically confirmed diagnosis of metastatic neuroendocrine CRPC will be enrolled in this study; 4. Patient must have progressive metastatic prostate cancer by at least 1 of the following criteria: Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Bone scan progression defined by 2 or more new lesions on bone scan. Prostate specific antigen (PSA) progression is determined by a minimum of three rising PSA levels with an interval of >=1 week between each determination. The screening PSA measurement (documenting progression) must be >=2 ng/mL; 5. Patients must be castrate-resistant (i.e. developed progression of metastases following surgical castration or during medical androgen ablation therapy) with documented castrate levels of testosterone =1.73 nmol/L (50 ng/dl). Patients receiving medical castration therapy with gonadotropin-releasing hormone (GnRH) analogues should continue this treatment during this study; 6. ECOG performance status 0-1; 7. Laboratory tests meet the following criteria: Hemoglobin >= 9.0 g/dL, Platelets >= 100 000/uL, Absolute neutrophil count (ANC) >= 1500/uL, within 10 days prior to the start of study treatment; Creatinine = 30 mL/min for participant with creatinine levels >1.5 institutional ULN; Creatinine clearance (CrCl) should be calculated per institutional standard; Total bilirubin ==6 months; 9. Patients who have received chemotherapy, abiraterone, enthralamide, radium-233, and Sipuleucel-T to improve survival must be discontinued for at least four weeks before the first medication.
Exclusion criteria
Exclusion criteria: 1. Non-metastatic, non-neuroendocrine crpc; 2. Patients in the control group who could not complete the DP chemotherapy treatment due to any other factors except treatment failure and severe side effects; 3. The experimental group could not complete the cycle of DC chemotherapy due to any other factors besides the failure of treatment and the termination of treatment due to serious side effects; 4. Patients who have contraindications to CT and MRI contrast agents and can not complete follow-up; 5. Allergies to any research drug, similar drug or any excipient in a research drug; 6. There are contraindications for prednisone use, such as active infections, active peptic ulcers, recent gastrointestinal anastomosis, fractures, trauma repair, corneal ulcers, severe osteoporosis or other conditions; 7. There are autoimmune diseases requiring corticosteroid therapy; 8. Within 6 months before admission, there were any of the following conditions: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, congestive heart failure (New York Heart Association Class III or IV); 9. Active viral hepatitis, human immunodeficiency virus infection with detectable viral load, or chronic liver diseases requiring treatment; 10. Any other serious or unstable disease or medical, social or psychological condition that may endanger the safety of the subjects or affect their compliance with the test procedures, or that may prevent the subjects from participating in the study or hinder the evaluation of the results of the study; 11. unable to swallow oral drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;pPFS;rPFS; | — |
Countries
China
Contacts
Public ContactWang Yong
The Second Hospital of Tianjin Medical University
Outcome results
None listed