Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

Inclusion Criteria

• Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations:
• Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage
• GS ≥ 8, PSA 40 mL/minute within 21 days prior to registration
• Bilirubin 150
• Definite evidence of metastatic disease.
• Pathologically positive lymph nodes or nodes > 2.0 cm on imaging.
• Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
• Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
• Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
• Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.

•Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume 50 days.

• Known hypersensitivity to TAK-700 or related compounds
• A history of adrenal insufficiency
• History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 [NCI CTCAE, version 4.02] (U.S. Department of Health and Human Services, National Institutes of Health National Cancer Institute, 2009), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to registration. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
• New York Heart Association Class III or IV heart failure.
• ECG abnormalities of:
• Q-wave infarction, unless identified 6 or more months prior to screening
• QTc interval > 460 msec
• Patients who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Prior allergic reaction to the drugs involved in this protocol.
• Study entry PSA obtained during the following time frames:
• 10-day period following prostate biopsy;
• following initiation of hormonal therapy.
• Cushing's syndrome
• Severe chronic renal disease (serum creatinine > 2.0 mg/dl and confirmed by creatinine clearance 1.5x ULN, ALT or AST > 2.5x ULN)
• Chronic treatment with glucocorticoids within one year
• Uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during Screening visit)
• Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
• Major surgery within 14 days prior to registration
• Serious infection within 14 days prior to registration
• Uncontrolled nausea, vomiting, or diarrhea [Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3] despite appropriate medical therapy at the time of registration
• Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets