metastatic castrated resistant prostate cancer (mCRPC)
Conditions
Interventions
Group 1:albumin-bound paclitaxel
Group 2:mitoxantrone
Sponsors
First People's Hospital of Yancheng City, Jiangsu Province
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. pathologically confirmed prostate cancer (stage IV); 2. aged between 20 and 80 years; 3. measurable or assessable lesions by imaging studies according to the RECIST guidelin; 4. received androgen-deprivation therapy including surgical castration (orchiectomy) or by suppression or pharmacological castration; 5. received enzalutamide, or abiraterone; 6. received first line chemotherapy with docetaxel before entry into the study; 7. Eastern Cooperative Oncology Group (ECOG) performance status score less than 3; 8. hepatic function (total bilirubin = 1.5 × the institutional upper limit of normal value, aspartate aminotransferase/alanine aminotransferase = 2.5 × the institutional upper limit of normal value, and alkaline phosphatase = 2.5 × the institutional upper limit of normal value), renal function (serum creatinine level = 1.5 mg/dL and creatinine clearance = 50 ml/min) and adequate bone marrow function (hemoglobin level = 90 g/L, white blood cell count of 4-10×109/L, neutrophil count = 2×10^9/L, and platelet count = 100×10^9/L); 9. estimated life expectancy more than 3 months.
Exclusion criteria
Exclusion criteria: 1. preexisted peripheral toxicity = grade 2 of the National Cancer Institute Common Toxicity Criteria; 2. concurrent or prior malignancy; 3. central nervous system metastases; 4. concurrent treatment that interfered with the study evaluation; 5. active infection; 6. other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment; 7. having inadequate calorie and fluid intake; 8. pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception; 9. with other secondary malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactDai Xichao
First People's Hospital of Yancheng City, Jiangsu Province
Outcome results
None listed