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

Status: Recruiting
Phase: Phase 3
Diagnosis: Prostate Cancer
NCT ID: NCT01546987 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-515


RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer. PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.


Conducting Institutions:
Massachusetts General Hospital, Massachusetts General Hospital/ North Shore Cancer Center, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Dror Michaelson, MD, Massachusetts General Hospital

Site-responsible Investigators:
Derek Chism, M.D., Massachusetts General Hospital North Shore Cancer Center
Irving Kaplan, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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
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