A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
With the larger number of men who undergo screening with assays for serum prostate specific
antigen, urologists continue to see considerable numbers of patients with locally advanced
prostate disease. There is a higher risk of treatment failure in any patient with a tumor
that extends through the prostate capsule, more aggressive pathology (Gleason score of 7 or
higher), or patients with a PSA of greater than 10 ng/ml. The rationale for adding
molecular targeted drugs such as Cetuximab (epithelial growth factor inhibitor), with or
without chemotherapy such as Docetaxel, is that such therapy has the potential to
demonstrate tumor shrinkage of the prostate and, in addition, micrometastatic cells.
Cetuximab alone or Cetuximab plus Docetaxel utilizing the preprostatectomy model, with the
adjuvant delivery of Cetuximab for 6 months, will provide data for the following points:
1. demonstration of a PSA response prior to prostatectomy;
2. demonstration whether a change in the natural history, with a delay in the onset of
metastatic disease in patients with advanced local prostate cancer, can be achieved;
3. laboratory and tissue correlation to assess changes in proliferative, apoptosis, and
pathologic parameters; and
4. metabolic imaging utilizing CT-PET with FDG to assess whether this will be a useful
modality in exhibiting a response to therapy, compared with conventional radiographic
imaging.
This will provide the basis for future development of neoadjuvant chemotherapy prior to
prostatectomy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Institutional Review Board
E-VS-ET-2006
NCT00448097
February 2007
August 2008
Name | Location |
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The Methodist Hospital Research Institute | Houston, Texas 77030 |