Status:
COMPLETED
Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer
Lead Sponsor:
University of Washington
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 (t...
Detailed Description
Androgen deprivation has long been the principal means of controlling advanced prostate cancer, but it does not cure the disease and all patients ultimately progress if tumor is not eliminated with de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00769795
Start Date
October 1 2008
End Date
November 1 2011
Last Update
March 29 2017
Active Locations (3)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
3
University of Washington Medical Center
Seattle, Washington, United States, 98195