Randomized, open label, multi-center, phase III study onpharmacokinetics, pharmacodynamics, efficacy and safety ofGoserelin 1M Implant HEXAL in patients with advancedprostatic cancer in comparison to Zoladex® 3.6 mg - Gosezol
- Conditions
- Palliative treatment of advanced prostatic cancer
- Registration Number
- EUCTR2004-000808-40-LT
- Lead Sponsor
- Hexal AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 90
Histologically confirmed diagnosis of advanced adenocarcinoma of the prostate
stage T3-4N0M0, T1-4N1M0 or T1-4N0-1M1,
• either as newly (within the past 4 weeks) diagnosed adenocarcinoma of the
prostate
• or recurrence of adenocarcinoma of the prostate after previous
prostatectomy and/or radiotherapy and/or brachytherapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Patients expected to require additional anti-neoplastic treatment during the study
period
2) Patients at particular risk of developing urethral obstructions and/or spinal cord
compression
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method