Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether combination treatment of prostate cancer with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than prior results with hormonal therapy alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: Androgens; Bicalutamide; Goserelin

Criteria

Inclusion Criteria:

• Men 18 years or older with clinically localized prostate cancer who have chosen surgery (prostatectomy) and are at high risk of cancer relapse due to clinical stage, Gleason Score, PSA level, or a combination of the three.

• Good health and laboratory values within reasonable limits

Exclusion Criteria:

• Patients with prostate cancer that has spread outside the prostate.

• Patients who have low testosterone

• Patients who have received hormonal therapies or drugs which affect hormone metabolism

• Patients with serious medical conditions such as diabetes, other cancers, stroke, cardiovascular disease.

• Patients who are receiving other investigational therapy or chemotherapy.

• Patients who are unwilling to use contraceptives during and for a short time after the study

• Inability to give informed consent for any reason