An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy
- Conditions
- prostate cancerprostate carcinoma1003858810036958
- Registration Number
- NL-OMON38143
- Lead Sponsor
- Ferring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Has given written informed consent before any trial-related activity is performed. ;2. Has prostate cancer, and is in need of this type of treatment.
1. Has had previous or is currently under hormonal treatment of prostate cancer. ;2. Is considered to be candidate for radical prostatectomy or radiotherapy. ;3. Has a history of severe uncontrolled asthma and/or other severe allergic reactions. ;4. Has hypersensitivity towards any component of degarelix. ;5. Has had cancer within the last five years except prostate cancer and some types of skin cancer. ;6. Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are median and between patient variability of time to<br /><br>PSA >4 ng/mL after 7 monthly injections of degarelix induction treatment.</p><br>
- Secondary Outcome Measures
Name Time Method