Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 thalidomide's 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 ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00038181
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: October 5, 2000
• Completion date: November 29, 2005