• Pathological response (prostate biopsy vs. prostatectomy specimen pathological evaluation): done pre-treatment vs. after prostatectomy at Week 10
  
• Clinical response: digital rectal exam pre-treatment and q 6 months after prostatectomy
  

• PSA response: tested q 3 weeks pre-prostatectomy and q 6 months post-prostatectomy
  
• Correlation with MRI and nuclear imaging: scans pre-treatment vs. Week 10 before surgery and yearly when PSA > 0.3
  
• Correlation with metabolic imaging (PET with FDG): scans pre-treatment vs. Week 10 before surgery
  
• Correlation with serum and plasma for antiangiogenic factors: tested q 3 weeks pre-prostatectomy
  

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.