Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT00672594
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2008-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.
Detailed Description:
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DUMC-8725 | OTHER | Duke legacy protocol number | View |