Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Phase II Study of Sorafenib (Nexavar®) Prior to Radical Prostatectomy in Patients With High-Risk Localized Prostate Cancer
This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Studying samples of blood and tumor tissues in the laboratory from patients with prostate cancer may help doctors learn more about changes that occur in DNA after treatment with sorafenib tosylate
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.
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