NCT00924807

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Leuprolide acetate, Bicalutamide, Sorafenib	Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-06-19
• Last updated: 2018-12-11
• Results posted: 2015-03-17

Locations

1 site across 1 country: United States