A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer
Inclusion Criteria:
- Patient has given written informed consent before any trial-related activity is
performed
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria:
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- Patients in need of external beam radiotherapy to be started at the same time as
hormone therapy
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT
interval over 450 msec., Torsades de Pointes or use of certain medications with
potential risk)
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate
cancer and some types of skin cancer.
- Clinical disorders other than prostate cancer including but not limited to renal,
haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric
disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Outcome Description:
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Outcome Time Frame:
After treatment of 12 weeks compared to Baseline
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
FE200486 CS28
NCT ID:
NCT00831233
Start Date:
April 2009
Completion Date:
July 2010
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|
