JHU ICTR
Johns Hopkins Clinical Research Study

andquot;Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancerandquot;
ClinicalTrials.gov

IRB Number: NA_00019223
Principal Investigator: Song, Daniel

Study Description:

This research is being done to learn about 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. Sutent® (sunitinib malate) is approved by the Food and Drug Administration (FDA) for the treatment of adults with kidney cancer.  It is not approved for use in prostate cancer.  The FDA is allowing the use of Sutent® (sunitinib malate) in this research study.

Men with prostate cancer may join this study. 
 
About 22 men will take part in this study across the country.  About 8 men will enroll  from Johns Hopkins.
 


Eligibility Criteria:

Subjects must be male and 18 years of age or older with Advanced Adenocarcinoma of the Prostate (specific features listed in eligibility). Subjects can not have metastatic disease. ECOG performance status of 0-1. Patients must meet certain criteria to be determined through routine blood draws. Subjects must not have had any prior VEGFR/PDGFR inhibitor or any other investigational therapy. Subject must not have any uncontrolled cardiac condition, HIV, alcoholism, hepatitis, or liver disease. 

 


Recruitment Contact Name:Shirl DiPasquale, RN
Contact Phone:410-614-1598
Contact E-Mail: sdipasq1@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Hospital East Baltimore Campus

Study will provide compensation: No



Keywords:

  • Prostate
  • Hormone Antagonists
  • Ablation Techniques
  • Radiation