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View Protocol Abstract: S1216
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The links after "Participants" show which SWOG institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

S1216 - Phase III
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
ClinicalTrials.gov Registry Number: NCT01809691
Treatment: TAK-700, Goserelin Acetate, Leuprolide Acetate, Bicalutamide

Research Committee: Genitourinary Cancer

Study Coordinator(s): Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.

Participants: Members, CCOP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY

Eligibility Criteria: Pts must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Pts
must have distant metastatic disease as evidenced by soft tissue and/or bony mets prior to initiation of androgen deprivation
therapy. Pts must have radiographic assessments of all disease including bone scan (or PET) within 42 days prior to registration. Pts with brain mets are not eligible. Prior androgen deprivation therapy (ADT) - neoadjuvant and/or adjuvant setting only - of no more than 36 months is allowed. At least 6 mo since completion of ADT, and serum testosterone must be > 50 ng/mL (non-castrate levels) at the time of registration for early induction pts. Must not have received ketoconazole, aminoglutethimide, or abiraterone acetate. Must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. At least 2 yrs since last cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting. Prior palliative RT for symptomatic bone or visceral mets, prior surgery, and current/planned bone targeting agents are allowed. Pts must not have plans to receive experimental therapy or LHRH antagonists. Pts must have had no more than 30 days since prior castration (medical or surgical). Pts must have a PSA>/=2 ng/mL. Pts must have a DEXA bone scan within the past 2yrs. Pts must not have any Grade III/IV cardiac disease, unstable angina pectoris, MI (w/in 6 mo), or serious uncontrolled cardiac arrhythmia. Pts must have QTc interval < 461 msec, ECHO/MUGA LVEF >50%, BP <160 mmHg systolic/<90 mmHg diastolic, bilirubin </= 2X IULN, AST/ALT </= 3X IULN (or 5X IULN, for liver mets), calculated creatinine >/= 40 mL/min, leukocytes >/= 3,000/mcL, ANC >/= 1,500/mcL, hemoglobin >/= 9 g/dL, and platelets >/= 100,000/mcL. Pts must not have HIV, Hep B/C,
or any serious medical or psychiatric illness. Pts with a Hx of of primary and secondary adrenal insufficiency are not eligible. Pts must not have hypersensitivity to TAK-700, TAK-700 metabolites, bicalutamide, or LHRH agonists. Pts must be able to take oral medications. Pts must have PS=0-2; PS=3 allowed (if from bone pain only). 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 pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 yrs. Pts must be 18 yrs of age or older. Pts must be offered the opportunity to participate in specimen banking for future use to include translational medicine studies outlined in Section 15.0.

Activation Date: 3/1/2013

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