Phase II Dutasteride in Combination With CAB vs CAB in SDC

Exclusion Criteria

• •Patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride
• •Patients with peanut or soy allergy (dutasteride capsules contain lecithin which may contain soy oil)
• •Patients who do not have adequate swallowing capacity
• •Patients familiar with Long QT-syndrome (LQTS)
• •Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
• •Patients that are pregnant or lactating
• •Patients with uncontrolled illness including:
• •Cardiovascular disorders, including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
• •Uncontrolled hypertension (defined as sustained systolic BP \> 160 mm Hg, or diastolic BP \> 100 mm Hg. Unless evidence of white-coat hypertension)
• •Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion
• •Serious active infections
• •Patients undergoing concomitant treatments including:
• •Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation
• •Concomitant (or within 6 months before inclusion) administration of any 5-alpha reductase inhibitor, i.e. dutasteride or finasteride
• •Concurrent treatment with any other anti-cancer therapy within the last 4 weeks before inclusion
• •Curative radiation therapy within the last 4 weeks before inclusion or palliative radiation therapy 1 week before start of study
• •Any condition which, in the opinion of the investigator, would preclude participation in this clinical study