Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084864
Status:
TERMINATED
Last Update Posted:
2017-06-12
First Post:
2004-06-10
Brief Title:
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma Cancer of the Prostate
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Pilot Trial of Calcitriol in Localized Prostate Cancer Investigation of Biologic Effects and Potential Intermediate Endpoints
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sample size is too small to draw a conclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Calcitriol and dexamethasone may slow the growth of prostate cancer cells
PURPOSE This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma cancer of the prostate
PURPOSE This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma cancer of the prostate
Detailed Description:
OBJECTIVES
Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate
Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients
Determine the effect of this regimen on the expression of apoptosis markers p21 p27 prostate-specific antigen PSA prostate-specific membrane antigen and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients
Determine the acute effects of this regimen on serum PSA in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a two-stage randomized pilot study
Stage 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery Within 48 hours of the last dose patients undergo radical prostatectomy
Arm II Patients receive no study drugs but undergo radical prostatectomy
Stage 2 If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1 the study is expanded and additional patients are randomized to 1 of 4 treatment arms
Arm I Patients receive dexamethasone and calcitriol as in stage 1 arm I
Arm II Patients receive oral dexamethasone once daily on days 1-4
Arm III Patients receive oral calcitriol once daily on days 2-4
Arm IV Patients undergo radical prostatectomy as in stage 1 arm II In arms I II and III patients undergo radical prostatectomy as in stage 1 arm I
Patients are followed at 1 3 and 12 months
PROJECTED ACCRUAL A total of 20-80 patients 20 for stage 1 10 per treatment arm and 60 for stage 2 will be accrued for this study within 2 years
Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate
Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients
Determine the effect of this regimen on the expression of apoptosis markers p21 p27 prostate-specific antigen PSA prostate-specific membrane antigen and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients
Determine the acute effects of this regimen on serum PSA in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a two-stage randomized pilot study
Stage 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery Within 48 hours of the last dose patients undergo radical prostatectomy
Arm II Patients receive no study drugs but undergo radical prostatectomy
Stage 2 If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1 the study is expanded and additional patients are randomized to 1 of 4 treatment arms
Arm I Patients receive dexamethasone and calcitriol as in stage 1 arm I
Arm II Patients receive oral dexamethasone once daily on days 1-4
Arm III Patients receive oral calcitriol once daily on days 2-4
Arm IV Patients undergo radical prostatectomy as in stage 1 arm II In arms I II and III patients undergo radical prostatectomy as in stage 1 arm I
Patients are followed at 1 3 and 12 months
PROJECTED ACCRUAL A total of 20-80 patients 20 for stage 1 10 per treatment arm and 60 for stage 2 will be accrued for this study within 2 years
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 |
|---|---|---|---|
| RPCI-RP-0212 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |