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

Phase 3

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: TAK-700
Drug: Bicalutamide

Registration Number: NCT01809691

Lead Sponsor: SWOG Cancer Research Network

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Male

Target Recruitment: 1313

Inclusion 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 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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADT + TAK-700	TAK-700	LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months. TAK-700, 300 mg, PO, twice daily
ADT + Bicalutamide	Bicalutamide	LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months. Bicalutamide, 50 mg, PO, q daily

Primary Outcome Measures

Name	Time	Method
Overall Survival	Duration of treatment and follow-up until death or 9 years after study start	Overall survival is defined as the time from random assignment to the date of death from any cause

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow-up until death or 9 years after study start	Only adverse events that are possibly, probably or definitely related to study drug are reported. Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) where grade refers to the severity of the AE. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
PSA Response Rates	7 months after randomization	Prostate-specific antigen (PSA) response rates were divided into complete response (CR: PSA \< 0.2 ng/mL), partial response (PR: PSA between 0.2 and 4.0 ng/mL), and no response (NR: PSA \> 4.0 ng/mL) at a 7-month landmark after random assignment.
Long-term Survival	After 10 years of follow-up	Long-term survival is defined as the time from random assignment to the date of death from any cause
Progression Free Survival	Duration of treatment and follow-up until death or 9 years after study start	Progression Free Survival (PFS) is defined as the time from random assignment to first documentation of PSA progression, radiologic progression, clinical progression, or death, whichever occurred first. PSA progression is defined as a ≥25% increase AND and absolute increase of at last 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment). Radiologic progression is defined as two or more new lesions on radionuclide bone scans. Clinical progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Trial Locations

Locations (558): Veterans Administration Medical Center - Birmingham
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Birmingham, Alabama, United States
University of Arizona Cancer Center at Saint Joseph's
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Phoenix, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
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Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
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Tucson, Arizona, United States
Southern Arizona Veterans Affairs Health Center
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Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
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Tucson, Arizona, United States
Fowler Family Center for Cancer Care
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Jonesboro, Arkansas, United States
Veteran's Administration Medical Center
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Little Rock, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
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Antioch, California, United States
Sutter Auburn Faith Hospital
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Auburn, California, United States
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Veterans Administration Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States