Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004043
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
1999-12-10
Brief Title:
Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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 Calcitriol a form of vitamin D may be able to prevent or slow the growth of prostate cancer cells
PURPOSE Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer
PURPOSE Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer
Detailed Description:
OBJECTIVES I Determine the response to pulse calcitriol in patients with previously treated adenocarcinoma of the prostate with rising PSA levels II Assess the impact of this regimen on the slope of the PSA rise in these patients III Determine the qualitative and quantitative toxic effects of this regimen in these patients IV Assess the impact of this regimen on the quality of life of these patients
OUTLINE All patients remain on a reduced calcium diet for the duration of the study Twelve hours prior to treatment patients begin drinking 4-6 glasses of extra fluid for 3 days Patients receive oral calcitriol over 4 hours weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline every 4 weeks during treatment and at the end of the study Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
OUTLINE All patients remain on a reduced calcium diet for the duration of the study Twelve hours prior to treatment patients begin drinking 4-6 glasses of extra fluid for 3 days Patients receive oral calcitriol over 4 hours weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline every 4 weeks during treatment and at the end of the study Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V99-1542 | None | None | None |
| OHSU-5231 | None | None | None |
| OCC-HOR-98068-L | None | None | None |