Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to
two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable
disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may
undergo an additional study of IFP monitoring before treatment and during week 4 of study
treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in
this patient population will be assessed. Extensive correlative science evaluations,
including assessment of physiologic, cellular, molecular and genetic changes during
treatment with Sunitinib malate, will be performed
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Apoptotic and proliferation indices demonstrated by pathologic measures in prostate cancer specimens before and after Sunitinib Malate treatment.
Before treatment and post surgery
No
Daniel J George, MD
Principal Investigator
Duke University
United States: Institutional Review Board
Pro00007396 (DUMC-8725)
NCT00672594
July 2006
September 2013
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |
MD Anderson, University of Texas | Houston, Texas |