Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
Drug: Sunitinib Malate
Radiation: Radiation Therapy (RT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer|
- Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) [ Time Frame: 8 week period of combined hormone ablation, Sunitinib, and radiation therapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
Injections given through a needle in the muscle every 3 months.
Other Name: LupronDrug: Goserelin
Subcutaneous injections given once every 3 months.
Other Name: ZoladexDrug: Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
Other Names:Drug: Casodex
Once a day by mouth for 2 weeks.
Other Name: BicalutamideRadiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
Other Name: Radiotherapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00631527
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paul Corn, MD, PHD||M.D. Anderson Cancer Center|