Multi-center study to evaluate long-term influences on lipid metabolism in prostate cancer patients who received androgen deprivation therapy.
Phase 2
Recruiting
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000004709
- Lead Sponsor
- Tohoku University, Dept. of urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have active another cancer 2)serious cardiovascular disease 3)uncontrollable diabetes 4)patients with hyperthyroidism, cushing syndrome, nephrotic syndrome 5)treated with estrogen (eg. Ethinylestradiol, estramustine) 6)treated with antiandrogen (eg. prostal) for benign prostatic hyperplasia 7)treated with 5alpha-reductase inhibitor (eg. dutasteride) for benign prostatic hyperplasia 8)treated with steroids (exclude external use for skin) 9)treated with other anticancer drugs 10)Patient who enrolled other clinical studies. 11)Patients who considered inappropriate for this trial by physicians
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in serum lipid (total cholesterol, triglyceride, HDL and LDL-cholesterol)
- Secondary Outcome Measures
Name Time Method 1.Percent change in fasting serum glucose. 2.Changes in body weight, waist circumference and body mass index (BMI). 3.Changes in abdominal fat area 4.Adverse events