A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy (RRP) in Select Patients With Locally Advanced Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 18
- Locations
- 1
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
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 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified