Phase I, open-label, single-center, multiple-dose, dose-escalation clinical study of SUO11248 (Sunitinib) in subjects with high-risk prostate cancer who have elected to undergo radical prostatectomy

Abstract

Introduction: Recent data suggest that the death rate from prostate cancer has been decreasing by 4% per year since 1994 [1], possibly reflecting prostate-specific antigen (PSA)-related early diagnosis and improvement in treatment. Approximately 30% of patients, however, initially present with clinical stage T3 prostate cancer. Patients with high-grade tumors on initial biopsy have a high risk for extracapsular disease. Patients with T1c-T2 tumors and Gleason’s score of eight to 10 have a 92% risk for extracapsular extension, whereas patients with T2b-T2c tumors, Gleason’s score of seven, and serum PSA greater than 10 ng/mL have more than a 73% risk for extracapsular extension of their disease. Fundamentally, no cancer patient is cured without achieving long-term local control. As a result, among patients who undergo prostatectomy with curative intent, 20% to 30% will suffer from disease recurrence as defined by serum PSA elevation [2,3]. Recurrent, metastatic disease contributes to the majority of the morbidity and mortality of prostate cancer. Unfortunately, no curative treatment exists for disseminated prostate cancer at this time [4]. To gain ground on the management of this aggressive stage of disease, investigation from several perspectives is urgently needed.