Finding studies
Finding studies
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Lead
University of Washington
With
PRIMARY OBJECTIVES: I. To compare the gene expression changes (transcript profiles) between pre- and post-treatment tumor specimens in order to determine the molecular impact of multi-kinase inhibition on prostate cancer. While this analysis will initially be targeted to tumor cells, gene expression changes in the surrounding stromal tissue may also be analyzed. SECONDARY OBJECTIVES: I. To determine if specific downstream protein effectors (i.e. ERK, AKT, and S6- kinase) of Sorafenib kinase targets are affected by changes in protein phosphorylation by immunohistochemistry. II. To provide evidence that Sorafenib has significant anti-tumor effect by comparison of pre- and post-treatment immunohistochemical markers of apoptosis (caspase-3), cell proliferation (Ki-67), and angiogenesis (microvessel density). III. To determine the pathologic complete response rate, defined as absence of cancer in the prostatectomy specimen. IV. To determine rates of positive surgical margins, extracapsular extension, seminal vesicle and lymph node involvement with tumor in comparison with Memorial Sloan Kettering pre-operative nomogram predictions. V. To determine the percentage of patients with a \>= 25% and \>= 50% decline in PSA while receiving Sorafenib. VI. To determine tissue Sorafenib levels in prostate tumors after treatment and correlate with molecular, clinical, and/or pathologic outcomes. VII. To describe changes in overall histology after treatment with Sorafenib and correlate with molecular and clinical outcomes. VIII. To determine if patients with baseline alterations in phospho-ERK, phospho-AKT, and phospho-S6-kinase expression correlate with treatment related molecular, clinical, and/or pathologic outcomes. IX. To collect tissue samples for future analysis of correlative biomarkers of prognosis or treatment response. X. To collect frozen plasma for future analysis of correlative biomarkers of treatment response (no genetic analysis will be performed on these specimens). OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 or 2 days after completion of sorafenib tosylate, patients undergo radical prostatectomy on approximately day 43. After completion of study treatment, patients are followed up for 6-10 weeks.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
