Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
|Study Start Date:||October 2000|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- To determine the efficacy (rate of tumor reduction and PSA decline) of pre-operative treatment with thalidomide in patients with locally advanced prostate carcinoma.
- 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.
To obtain qualitative measurements of thalidomide's effect in vivo on:
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
- Apoptosis in prostate cancer cells (TUNEL)
- Proliferation (PCNA)
- quality of life