A clinical trial to study the effects of two drugs, ozarelix and goserelin in men with prostate cancer
Phase 2
Completed
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2010/091/006141
- Lead Sponsor
- Spectrum PharmaceuticalsInc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
Exclusion Criteria
Any hormone therapy prior to study entrance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with testosterone less than or equal to 0.5ng/mL in each groupTimepoint: Day 28 through Day 84,
- Secondary Outcome Measures
Name Time Method 1)Testosterone surge <br/ ><br>2)Percentage of patients with less than or equal to 0.5 ng/ml <br/ ><br>3) median time to reach 50% suppression of baseline PSA level <br/ ><br>4) Safety <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 1) during the first two weeks of treatment <br/ ><br>2) at Day 3 <br/ ><br>