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

DISEASE CHARACTERISTICS:

• 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 (risk group):

  • Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage
  • GS ≥ 8, PSA < 20 ng/mL, T stage ≥ T2
  • GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage
  • GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage

• Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) agonist or antiandrogen therapy, within 180 days of randomization

  • Study entry PSA obtained during the following time frames:

    • 10-day period following prostate biopsy
    • Following initiation of hormonal therapy

• Clinically negative lymph nodes as established by imaging (abdominal and pelvic CT or abdominal and pelvic MRI), nodal sampling, or dissection within 90 days prior to registration

  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm

• No distant metastases (M0) on bone scan within 90 days prior to registration

  • Equivocal bone scan findings are allowed if plain films are negative for metastasis
  • No definite evidence of metastatic disease

• Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score ≤ 15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP)

  • Prior TURP is permitted for patients who receive external-beam radiotherapy (EBRT) only

PATIENT CHARACTERISTICS:

• Height, weight, Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
• Platelets ≥ 100,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dL (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
• Serum creatinine < 2.0 mg/dL
• Creatinine clearance > 40 mL/minute
• Bilirubin < 1.5 x upper limit of normal (ULN)
• ALT or AST < 2.5 x ULN
• No PSA > 150 ng/mL
• Screening calculated ejection fraction ≥ ULN by multiple-gated acquisition (MUGA) scan or by echocardiogram
• Patients, even if surgically sterilized (i.e., status post vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug
• No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years
• No known hypersensitivity to TAK-700 or related compounds
• No history of adrenal insufficiency

• No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (NCI CTCAE, version 4.02) thromboembolic events (e.g., 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
• No New York Heart Association Class III or IV heart failure
• No ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening, or QTc interval > 460 msec
• No prior allergic reaction to the drugs involved in this protocol
• No Cushing syndrome
• No severe chronic renal disease or chronic liver disease
• No 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)
• No serious infection within 14 days prior to registration
• No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration
• No known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior testosterone administration is allowed if last administered at least 90 days prior to registration
• No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

• No prior systemic chemotherapy for prostate cancer

  • Prior chemotherapy for a different cancer is allowed
• No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields
• No previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy)
• No chronic treatment with glucocorticoids within one year
• No major surgery within 14 days prior to registration
• No other investigational agent
• No other anticancer therapy
• No concurrent hormonal therapies including estrogens or herbal products
• No concurrent ketoconazole or aminoglutethimide
• No chronic use of systemic corticosteroids, such as oral prednisone