Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

Recruiting in Palo Alto (17 mi)

+169 other locations

Overseen byEvan Yu

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.

Eligibility Criteria

Inclusion Criteria

Visceral disease (liver, lung, or other viscera)

Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton

Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.)

See 7 more

Treatment Details

Interventions

Bicalutamide (Antiandrogen)
Cixutumumab (Monoclonal Antibodies)
Goserelin Acetate (LHRH Agonist)
Leuprolide Acetate (LHRH Agonist)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (androgen deprivation and cixutumumab)Experimental Treatment6 Interventions

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (androgen deprivation therapy)Active Control5 Interventions

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide is already approved in European Union, United States, Japan, Canada, Australia for the following indications:

🇪🇺 Approved in European Union as Casodex for: