Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer
Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide
(an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood
level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a
standard treatment for localized prostate cancer. Previous studies have shown that
combining hormonal therapy and radiation is more effective than radiation alone.
Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces
the growth of cancer cells and has proven effective in the treatment of solid tumors
including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and
liver cancer. The study investigators believe that adding sorafenib to standard treatment,
comprising hormonal therapy and radiation, might be more effective then standard hormonal
therapy.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determine the safety and maximally tolerated dose of sorafenib administered concurrently with radiotherapy in the treatment of intermediate- and high-risk localized prostate cancer.
Day 29 and every 2 weeks
Yes
Seth Cohen, MD
Principal Investigator
St. Luke's-Roosevelt Hospital Center
United States: Institutional Review Board
IRB# 004-08
NCT00924807
September 2008
December 2013
Name | Location |
---|---|
St.Luke's-Roosevelt Hospital Center | New York, New York 10019 |