Conditions: Prostate Cancer
Keywords: Prostate Cancer Combined Androgen Blockade Radiotherapy Sorafenib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Interventions: intervention 1: Leuprolide acetate, Bicalutamide, Sorafenib
Intervention descriptions: intervention 1: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Protocol document: