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A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
Inclusion and Exclusion Criteria
- - Clinical diagnosis of metastatic prostate cancer. - Serum testosterone within institutional limits of normal. - PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction). - DEXA scan within 2 years prior to registration. - ECG within 42 days prior to registration and QTc interval ≤ 460 msec. - LVEF within 42 days prior to registration and within institutional limits of normal. - Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present. - Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min. - Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
- Zubrod performance status 3 will be allowed if from bone pain only. - ≥ 18 years of age. - Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.
- Known brain metastases.
- No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
- ≥ 6 months since completion of androgen deprivation therapy.
- Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
- Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
- ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
- Concurrent use of experimental therapy is not allowed.
- ≥ 30 days since prior medical castration for metastatic prostate cancer.
- If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
- If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
- Prior bilateral orchiectomy.
- Concurrent use of LHRH antagonists (e.g. Degarelix)
- Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
- Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
- Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
- History of primary and secondary adrenal insufficiency.
- Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
- Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- University of Southern California, Los Angeles, California, 90033
- Keck Medical Center of USC, Pasadena, California, 91105
- City of Hope, Duarte, California, 91010
- University of California Medical Center At Irvine-Orange Campus, Orange, California, 92868
- Loma Linda University Medical Center, Loma Linda, California, 92354
- UC San Diego Moores Cancer Center, LA Jolla, California, 92093
- Kaiser Permanente, Hayward, Hayward, California, 94545
- UCSF-Mount Zion, San Francisco, California, 94115
- Mather Veteran Affairs Medical Center, Mather, California, 95655
- UC Davis Comprehensive Cancer Center, Sacramento, California, 95817
- Tahoe Forest Cancer Center, Truckee, California, 96161
- Fremont - Rideout Cancer Center, Marysville, California, 95901
- Arizona Cancer Center at UMC Orange Grove, Tucson, Arizona, 85704
- Arizona Cancer Center at University Medical Center North, Tucson, Arizona, 85719
- University of Arizona Health Sciences Center, Tucson, Arizona, 85724
- Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112
- University of New Mexico, Albuquerque, New Mexico, 87106
- Hematology Oncology Associates, Albuquerque, New Mexico, 87106
- New Mexico Cancer Care Associates, Santa Fe, New Mexico, 87505
- Southwest Oncology Group, San Antonio, Texas, 78245
- University of Texas Southwestern Medical Center, Dallas, Texas, 75390
- Baylor College of Medicine, Houston, Texas, 77030
- Ben Taub General Hospital, Houston, Texas, 77030
- Veterans Administration Medical Center, Houston, Texas, 77030
- Topeka VA Hospital, Topeka, Kansas, 66622
- Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, 64128
- University of Missouri - Ellis Fischel, Columbia, Missouri, 65203
- Veteran's Administration Medical Center, Little Rock, Arkansas, 72205
- Mayo Clinic, Rochester, Minnesota, 55905
- Essentia Health Duluth Clinic CCOP, Duluth, Minnesota, 55805
- VA Medical Center - University of Iowa, Iowa City, Iowa, 52246
- Louisiana State University Health Science Center, New Orleans, Louisiana, 70112
- Interim LSU Public Hospital, New Orleans, Louisiana, 70112
- Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, 60435
- Loyola University Medical Center, Maywood, Illinois, 60153
- University of Illinois, Chicago, Illinois, 60612
- Weiss Memorial Hospital, Chicago, Illinois, 60640
- Saint Joseph Hospital, Chicago, Illinois, 60657
- University of Chicago, Chicago, Illinois, 60637
- Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, 53226
- Erlanger Medical Center, Chattanooga, Tennessee, 37403
- University of Kentucky, Lexington, Kentucky, 40536
- Atlanta VA Medical Center, Decatur, Georgia, 30033