Prostate cancer is the most common malignancy and second cause of cancer death in males in the United States. In most cases, death results within about 1 year from progression to hormone-refractory (HRPC) metastatic disease, which is often attended by severe bone pain due to metastasis. No form of post-hormonal manipulative therapy has yet been definitively demonstrated to prolong survival. Exploratory treatment approaches are highly justified to attempt to identify more effective agents. This is a single-arm Phase II study to evaluate the response rate of patients with metastatic (M1/D1-2 disease) hormone refractory prostate cancer to intravenous arsenic trioxide therapy. This is a collaborative study between the Montefiore Medical Center, Bronx, New York and the Mount Sinai Medical Center, New York, New York. It will have a standard two-stage accrual design for early termination in the event of insufficient ageny efficacy.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000071-37
Application #
6413491
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1975-10-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
37
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Mount Sinai School of Medicine
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10029
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