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Sorafenib in Treating Patients Undergoing Radical Prostatectomy for High-Risk Localized Prostate Cancer

2014-08-27 03:38:50 | BioPortfolio

Summary

RATIONALE: DNA analysis of tumor tissue may help doctors understand changes in gene expression after treatment with sorafenib.

PURPOSE: This phase II trial is evaluating gene expression after treatment with sorafenib in patients undergoing radical prostatectomy for high-risk localized prostate cancer.

Description

OBJECTIVES:

Primary

- Compare gene expression changes (i.e., transcript profiles) in pre- vs post-treatment tumor specimens from patients with high-risk localized prostate cancer treated with neoadjuvant sorafenib tosylate.

Secondary

- Determine the effect of changes in protein phosphorylation on specific downstream protein effectors (i.e., ERK, AKT, and S6- kinase) of sorafenib tosylate kinase targets in these patients.

- Compare pre- vs post-treatment immunohistochemical markers of apoptosis (caspase-3), cell proliferation (Ki-67), and angiogenesis (microvessel density) as a measure of antitumor response in these patients.

- Determine the pathologic complete response rate in these patients.

- Compare rates of positive surgical margins, extracapsular extension, and seminal vesicle and lymph node involvement with tumor vs Memorial Sloan Kettering pre-operative nomogram predictions in these patients.

- Determine the percentage of patients with a ≥ 25% and ≥ 50% decline in PSA.

- Determine sorafenib tosylate tissue levels in prostate tumors after treatment and correlate with molecular, clinical, and/or pathologic outcomes in these patients.

- Determine overall changes in histology after treatment and correlate with molecular and clinical outcomes in these patients.

- Correlate baseline alterations in phospho-ERK, phospho-AKT, and phospho-S6-kinase expression with treatment related molecular, clinical, and/or pathologic outcomes in these patients.

- Collect tissue samples for future analysis of correlative biomarkers of prognosis or treatment response.

- Collect frozen plasma for future analysis of correlative biomarkers of treatment response.

OUTLINE: This is a pilot study.

Patients receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. On approximately day 43 (1-3 days after the completion of sorafenib tosylate), patients undergo radical prostatectomy.

Patients undergo needle biopsies and blood collection at baseline and after completion of study treatment for analysis of biomarkers by immunohistochemistry and microarray gene analysis.

After completion of study treatment, patients are followed for 6-10 weeks.

PROJECTED ACCRUAL: At total of 20 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

sorafenib tosylate, microarray analysis, immunohistochemistry staining method, conventional surgery, needle biopsy, neoadjuvant therapy

Location

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles
California
United States
90089-9181

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:50-0400

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