Prostate Cancer
Conditions
Interventions
1:Surgical/Medical castration + Casodex 50mg po. Qd
2:Casodex 50mg po. Qd
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The histopathological diagnosis of prostate cancer; 2. Radical prostatectomy (laparoscopy or laparotomy) within one month, and pathologic stage T3 or positive margin above or regional lymph node metastasis or localized prostate cancer, but the preoperative PSA >=20ng/ml, Gleason score >=8; 3. After 2-4 weeks of baseline serum PSA 18 years; 6. WHO performance status 0 to 1; 7. The expected survival >=12 weeks; 8. Subjects volunteered to participate and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Neoadjuvant endocrine therapy used before radical prostatectomy; 2. Research involving drugs with contraindications, including known or suspected allergy to th study drugs involved; 3. Other anti-tumor treatment or drugs applied simultaneously; 4. With other malignancy (except basal cell skin cancer or other cancer cured for 5 years); 5. 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; 6. Enrollment in other clinical studies within 30 days; 7. Known or suspected poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year biochemical progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival;2-year overall survival;2-year disease-specific survival;Time to progression;Quality of life; | — |
Countries
China
Contacts
Public ContactYe, Dingwei
Outcome results
None listed