SWOG clinical trial number
S1216
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
Closed
Phase
Accrual
100%
Abbreviated Title
Metastatic Prostate Cancer, Phase III ADT+TAK-700 vs. ADT+Bicalutamide
Activated
03/01/2013
Closed
07/15/2017
Participants
Research committees
Genitourinary Cancer
Treatment
Bicalutamide
Leuprolide Acetate
Goserelin Acetate
TAK-700
Eligibility Criteria Expand/Collapse
Pts must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Pts
must have 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. Pts deemed high risk or extensive metastatic HSPC eligible if unsuitable or have declined docetaxel. 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 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 Grade III/IV heart failure at time of screening. Pts must not have any thromboembolic event, unstable angina pectoris, MI, or serious uncontrolled cardiac arrhythmia w/in 6 mo prior to registration. Pts must have the following w/in 28 days prior to registration: PE & Hx, 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.
must have 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. Pts deemed high risk or extensive metastatic HSPC eligible if unsuitable or have declined docetaxel. 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 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 Grade III/IV heart failure at time of screening. Pts must not have any thromboembolic event, unstable angina pectoris, MI, or serious uncontrolled cardiac arrhythmia w/in 6 mo prior to registration. Pts must have the following w/in 28 days prior to registration: PE & Hx, 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.
Publication Information Expand/Collapse
2024
PMid: PMID37085425 | PMC number: PMC10662935
2023
2022
PMid: PMID35446628 | PMC number: PMC9553390
2021
PMid: PMID33500355 | PMC number: PMC8026618
2020
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