A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Degarelix
Experimental
Not Provided
Goserelin and bicalutamide
Active Comparator
Not Provided
Intervention(s)
Degarelix, Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®),
Patient eligibility
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
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or ?-adrenoceptor antagonist.
- 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.
- 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)
- 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.
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
