S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

Key facts

Study ID

NCT01809691

Run by

SWOG Cancer Research Network

People needed

1313

Starts

2013-03-08

Expected to finish

2025-09-09

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 of 0 - 2. 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Southern Arizona Veterans Affairs Health Center — Tucson, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• Veteran's Administration Medical Center — Little Rock, Arkansas, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• City of Hope Corona — Corona, California, United States
• Sutter Davis Hospital — Davis, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• University Oncology Associates — Fresno, California, United States
• Kaiser Permanente — Fresno, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Veterans Administration Medical Center - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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