Impact of endocrine therapy on lipid metabolism and bone metabolism of prostate cancer patients -Comparison with chlormadinone acetate and bicalutamide

Not Applicable

• Conditions: Prostate cancer

• Registration Number: JPRN-UMIN000018478
• Lead Sponsor: agasaki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-10
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between treatment groups of lipid metabolism marker rate of change in two years from endocrine therapy start

Secondary Outcome Measures

Name	Time	Method
- 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