TAK-700 vs. Bicalutamide for Prostate Cancer

(S1216 Trial)

Recruiting in Palo Alto (17 mi)

+559 other locations

Overseen by Neeraj Agarwal, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Southwest Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neeraj Agarwal, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for men with newly diagnosed metastatic prostate cancer who have a good performance status, meaning they can carry out daily activities with little to no assistance. They must have adequate liver, heart, and kidney function, agree to use contraception if of reproductive potential, and not have any serious illnesses that could interfere with the study. Men previously treated for other cancers may be eligible if they are in remission.

Inclusion Criteria

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

DEXA scan within 2 years prior to registration

ECG within 42 days prior to registration and QTc interval ≤ 460 msec

Exclusion Criteria

Concurrent use of experimental therapy is not allowed

It has been over 30 days since my last hormone therapy for prostate cancer.

I am currently using LHRH antagonists like Degarelix.

Treatment Details

Interventions

• Bicalutamide (Antiandrogen)
• TAK-700 (Androgen Synthesis Inhibitor)

Trial Overview The study aims to compare the effectiveness of two treatments on overall survival rates: one group will receive TAK-700 plus standard hormone therapy (ADT), while another group will get bicalutamide along with ADT. Participants are randomly assigned to either treatment path.

Participant Groups

Group I: ADT + TAK-700 Experimental Treatment 1 Intervention

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

Group II: ADT + Bicalutamide Active Control 1 Intervention

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

Bicalutamide is already approved in Japan, Canada for the following indications:

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

Millennium Pharmaceuticals, Inc.

Industry Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School