Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038181
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2002-05-29
Brief Title:
Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy RRP in Select Patients With Locally Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-11
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:
The goal of this clinical research study is to find out whether it is safe to treat patients diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the tumor radical retropubic prostatectomy
Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate cancer before the surgery
Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate cancer before the surgery
Detailed Description:
1 To determine the efficacy rate of tumor reduction and PSA decline of pre-operative treatment with thalidomide in patients with locally advanced prostate carcinoma
2 To determine the safety and toxicity excessive bleeding wound healing problems of preoperative therapy with thalidomide in patients with locally advanced prostate carcinoma who undergo RRP
3 To obtain qualitative measurements of thalidomides effect in vivo on
1 endothelial cells neo-vascularity angiogenic growth factors
Assessment of neovascularity MVD
Dual fluorescent labeling technique to evaluate apoptosis in CD-31 positive cells TUNEL
bFGF VEGF EGF and TGF expression by PCa epithelium and prostatic stroma
Modulation of endothelial markers serum E-selectin and Thrombomodulin
Modulation of serum VEGF and urine bFGF levels and Changes in tumor blood flow
2 epithelial compartment
Apoptosis in prostate cancer cells TUNEL
Proliferation PCNA
3 quality of life
2 To determine the safety and toxicity excessive bleeding wound healing problems of preoperative therapy with thalidomide in patients with locally advanced prostate carcinoma who undergo RRP
3 To obtain qualitative measurements of thalidomides effect in vivo on
1 endothelial cells neo-vascularity angiogenic growth factors
Assessment of neovascularity MVD
Dual fluorescent labeling technique to evaluate apoptosis in CD-31 positive cells TUNEL
bFGF VEGF EGF and TGF expression by PCa epithelium and prostatic stroma
Modulation of endothelial markers serum E-selectin and Thrombomodulin
Modulation of serum VEGF and urine bFGF levels and Changes in tumor blood flow
2 epithelial compartment
Apoptosis in prostate cancer cells TUNEL
Proliferation PCNA
3 quality of life
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