Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy

Exclusion Criteria

• •1. Previous surgical/endoscopic treatments for prostatic disease
• •2. Herbal and non-herbal products that in the opinion of the investigator may decrease PSA levels
• •3. cM1 disease
• •4. Any contraindication for PET or MR investigations
• •5. History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
• •6. Medications known to lower the seizure threshold
• •7. History of:
• •* Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
• •* Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
• •* Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
• •* Gastrointestinal disorder affecting absorption
• •8. Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.