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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center
• Collaborator: Bayer
• Treatments: Androgens; Bicalutamide; Leuprolide; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.

• Age > 18 years.

• Life expectancy of greater than 5 years.

• Patients must have normal organ and marrow function.

• No pelvic lymph node metastases based on pelvic CT scan or MRI.

• No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

• Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.

• Patients may not be receiving any other investigational agents.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.

• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.

• Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.