A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients
Not Applicable
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000005630
- Lead Sponsor
- Biwako health and welfare consortium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1. AST (GOT), ALT (GPT), ALP: > 2.5 times of institution standard value. 2. Serum creatinine: > 1.5 times of institution standard value. 3. WBC: < 3,000/mm3 4. Hemoglobin: < 10 g/dl 5. Platelet: < 75,000/mm3 6. Patient with critical illness (liver cirrhosis, liver failure, chronic kidney failure, heart failure, myocardial infarction within 3 months, uncontrolled hypertension, uncontrolled diabetes, serious pulmonary fibrosis, active interstitial pneumonia, immunodeficiency, active double cancer, etc) 7. Patients participating in any clinical researches or clinical trials. 8. Patients who were judged inappropriate for the clinical research by the investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSA level Normalization rate of PSA level
- Secondary Outcome Measures
Name Time Method IPSS Serum hormone Prostate volume Adverse event