Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448097
Status:
TERMINATED
Last Update Posted:
2016-03-17
First Post:
2007-03-14
Brief Title:
Efficacy and Safety Study of Cetuximab or Cetuximab Plus Docetaxel to Treat Prostate Cancer Before Prostatectomy
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
A Randomized Study of Cetuximab or Cetuximab Plus Docetaxel Followed by Radical Prostatectomy for Patients With Adenocarcinoma of the Prostate
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patient population - slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ngml 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-VS-ET-2006 | OTHER | Principal Investigator | None |