Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466752
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2007-04-25
Brief Title:
Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase II Study of Sorafenib Nexavar Prior to Radical Prostatectomy in Patients With High-Risk Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ie 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 andor 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 andor 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
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 ie 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00604 | REGISTRY | CTRP Clinical Trial Reporting Program | None |