The purpose of this study is to differentiate between the administrations of Cetuximab alone vs. Cetuximab plus Docetaxel in the treatment of non-metastatic prostate cancer before the surgical removal 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States
Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
No verifiable data available, PI relocated
Time frame: during study
Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
No verifiable data available, PI relocated
Time frame: during study
PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
No verifiable data available, PI relocated
Time frame: during study
Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
No verifiable data available, PI relocated
Time frame: during study
Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
No verifiable data available, PI relocated
Time frame: during study
Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
No verifiable data available, PI relocated
Time frame: during study
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