Enzalutamide + External Beam Rt For Prostate

Inclusion Criteria

• Study population: Participants must have histologically confirmed malignancy and are candidates for external beam radiation therapy. Patients eligible for this study must have intermediate risk disease defined as PSA values between 10-20 ng/ml and/or T2b-c and/or Gleason grade 7. If all three are present, less than 50% of the core biopsies can be positive.
• Patients previously diagnosed with low risk (Gleason score 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the screening visit;
• EKG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of oral study drug(s) within 3 months of enrollment.
• Major surgery within 4 weeks of registration.
• Previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., enzalutamide, BMS 641988); ketoconazole.
• Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, places the patient at undue risk, or complicates the interpretation of safety data.
• Need for any of the medications on the list of drugs to be used with caution or to be avoided (see APPENDIX F).
• Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES.