Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00924807
- Run by
- Beth Israel Medical Center
- People needed
- 4
- Starts
- 2008-09-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- St.Luke's-Roosevelt Hospital Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.