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

SWOG Cancer Research Network558 sites in 1 country1,313 target enrollmentMarch 8, 2013

ConditionsProstate Cancer

InterventionsTAK-700 Bicalutamide

DrugsTAK-700 Bicalutamide

Overview

Phase: Phase 3
Intervention: TAK-700
Conditions: Prostate Cancer
Sponsor: SWOG Cancer Research Network
Enrollment: 1313
Locations: 558
Primary Endpoint: Overall Survival
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2013

End Date

September 9, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

SWOG Cancer Research Network

Responsible Party

Sponsor

Eligibility Criteria

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 -

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).

Arms & Interventions

ADT + 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

Intervention: TAK-700

ADT + 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

Intervention: Bicalutamide

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 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 Outcomes

PSA Response Rates(7 months after randomization)
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)
Long-term Survival(After 10 years of follow-up)
Progression Free Survival(Duration of treatment and follow-up until death or 9 years after study start)