Status:
TERMINATED
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
Lead Sponsor:
Beth Israel Medical Center
Collaborating Sponsors:
Bayer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 radi...
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 prost...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00924807
Start Date
September 1 2008
End Date
December 1 2013
Last Update
December 11 2018
Active Locations (1)
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1
St.Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019