Prostate cancer
Conditions
Interventions
GnRH agonists (12-13 weeks each)and Chlormadinone acetate 50mg (Twice daily)
GnRH agonists (12-13 weeks each)and Bicalutamide 80mg (Once a day)
Sponsors
Nagasaki University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically who prostate (adenocarcinoma) have been identified (in all stages, EOD score 2 or less). 2. Who it is deemed necessary endocrine therapy for prostate cancer. 3. voluntary written informed consent 4. Age at the time of consent acquired more than 20 years of age 5. ECOG Performance Status 0-1 6. Organ function is maintained with the latest test values within registration before 4 weeks -WBC>=3000/mm3 -PLT>=100,000/mm3 -Hemoglobin>=9.0g/dl -ALT <= 2.5 x upper limit of normal -AST <= 2.5 x upper limit of normal - total bilirubin <= 1.5mg/dl -creatinine <= 1.5mg/dl 7. Patients who are expected to survive more than 12 months 8. Initiation of therapy capable person within 4-8 weeks after registration.
Exclusion criteria
Exclusion criteria: 1. Those who have received those who had received endocrine therapy current or against prostate cancer in the past. 2. A person who has received chemotherapy in the past. 3. A person who has been treated with estrogen agent in the past. 4. Those who received radiation therapy to the primary tumor or metastases within the past 3 months. 5. Of a person merger or suspicion of clinically important liver disease or symptomatic of hepatobiliary disease. 6. Those who have developed ischemic heart disease within 6 months 7. A person having control difficult complications (heart disease, severe diabetes, bleeding, etc.). 8. Administration contraindication: CMA, Bicalutamide, goserelin acetate, acetic acid leuprorelin 9. Those of active double cancer. 10. There is a thrombotic predisposition, or person who has a thrombosis. 11. Registration within 28 days prior person who has used other investigational drugs and clinical trials for medical equipment and post-marketing clinical study drug. 12. Person who is pregnant or lactating Person judged as unsuitable for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between treatment groups of lipid metabolism marker rate of change in two years from endocrine therapy start | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes of bone density - Bone metabolism marker rate of change - Change of Aortocalcification index - Changes of taste and preferences - Changes of the quality of life - progression-free survival - Adverse event | — |
Countries
Japan
Contacts
Public ContactTomoaki Hakariya
Nagasaki University Hospital Department of Nephro-Urology
Outcome results
None listed