prostate cancer
Conditions
Interventions
2:Hormonal therapy combined with docetaxel
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed prostate adenocarcinoma; 2. High-volume metastatic disease meeting any of the following criteria: Visceral metastases (extranodal) or Bone metastases(over 3 bone lesions); 3. To be aged betwen 18 Years old and 85 Years old; 4. ECOG performance status (PS) 0-2; 5. Life expectance longer than 12 weeks; 6. Subjects volunteered to participate and signed informed consent; 7. Prior hormone therapy shorter than 2 months; 8. One week before enrollment, the labatory test meeting any of the following criteria: (1) Absolute neutrophil count more than 2.0*10^9/L, Platelet count more than 100*10^9/L, Hemoglobin more than 10g/dL; (2) Bilirubin less than upper limit of normal (ULN), ALT less than 2.5 times ULN, AST less than 2.5 times ULN, AKP less than 2.5 times ULN; (3) Creatinine clearance more than 30 mL/min; 9. Patients must obey to receive treatment and follow-up; 10. Fertility patients should make effective measures to prevent pregnancy, from signing informed consent to 6 months after the end of this trial.
Exclusion criteria
Exclusion criteria: 1. Prior hormone therapy for metastatic prostate cancer >2 months; 2. Prior chemotherapy for metastatic prostate cancer; 3. Prior palliative radiotherapy for metastatic lesions within 4 months; 4. Prior castration more than 2 months; 5. Patients with castration refractory prostate cancer; 6. Patients with brain metastatic lesions; 7. Prior malignancy(except basal cell skin cancer or other cancer cured for 5 years); 8. Peripheral neuropathy greater than grade 2; 9. With other serious diseases, such as: unstable heart disease, the first 6 months of myocardial infarction; serious neurological or psychological disorders including dementia or seizures; uncontrolled active infection and other conditions might affect the research subjects or compliance determined by researchers; 10. Other anti-tumor treatment or drugs applied simultaneously; 11. Enrollment in other clinical studies within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time To clinical Progression;Time To biochemical Progression;Time To Castration-resistant prostate cancer;PSA response;Quality of life; | — |
Countries
China
Contacts
Public ContactDingwei Ye
Outcome results
None listed