Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086736
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2004-07-08
Brief Title:
Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone Bicalutamide Alone and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine DFMO Versus Bicalutamide CASODEX Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as eflornithine work in different ways to stop tumor cells from dividing so they stop growing or die Androgens can stimulate the growth of prostate cancer cells Drugs used in hormone therapy such as bicalutamide may fight prostate cancer by stopping the adrenal glands from producing androgens Combining eflornithine with bicalutamide may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine and bicalutamide with that of eflornithine alone bicalutamide alone and no neoadjuvant therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for localized prostate cancer
PURPOSE Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine and bicalutamide with that of eflornithine alone bicalutamide alone and no neoadjuvant therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for localized prostate cancer
Detailed Description:
OBJECTIVES
Compare levels of polyamine spermine polyamine putrescine and spermidine in patients with localized prostate cancer undergoing brachytherapy or radical prostatectomy and treated with neoadjuvant eflornithine and bicalutamide vs eflornithine alone vs bicalutamide alone vs no neoadjuvant therapy
Compare the expression of surrogate biomarkers ie serum prostate-specific antigen tissue levels of proliferating cell nuclear antigen Ki67 and TGF-alpha apoptosis assays ICH-PARP and TUNEL and cytomorphometric indices in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to Gleason score 7 vs 7 Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral eflornithine and oral bicalutamide once daily
Arm II Patients receive oral eflornithine and oral bicalutamide placebo once daily
Arm III Patients receive oral eflornithine placebo and oral bicalutamide once daily
Arm IV Patients receive oral eflornithine placebo and oral bicalutamide placebo once daily
In all arms treatment continues for 28 days in the absence of unacceptable toxicity Patients then undergo either prostatectomy or brachytherapy as determined by the patient on day 29
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 44 patients 11 per treatment arm will be accrued for this study within 11 months
Compare levels of polyamine spermine polyamine putrescine and spermidine in patients with localized prostate cancer undergoing brachytherapy or radical prostatectomy and treated with neoadjuvant eflornithine and bicalutamide vs eflornithine alone vs bicalutamide alone vs no neoadjuvant therapy
Compare the expression of surrogate biomarkers ie serum prostate-specific antigen tissue levels of proliferating cell nuclear antigen Ki67 and TGF-alpha apoptosis assays ICH-PARP and TUNEL and cytomorphometric indices in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to Gleason score 7 vs 7 Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral eflornithine and oral bicalutamide once daily
Arm II Patients receive oral eflornithine and oral bicalutamide placebo once daily
Arm III Patients receive oral eflornithine placebo and oral bicalutamide once daily
Arm IV Patients receive oral eflornithine placebo and oral bicalutamide placebo once daily
In all arms treatment continues for 28 days in the absence of unacceptable toxicity Patients then undergo either prostatectomy or brachytherapy as determined by the patient on day 29
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 44 patients 11 per treatment arm will be accrued for this study within 11 months
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 |
|---|---|---|---|
| UAB-F990728039 | None | None | None |
| UAB-9921 | None | None | None |