Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482157
Status:
WITHDRAWN
Last Update Posted:
2022-03-03
First Post:
2007-05-31
Brief Title:
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Status:
WITHDRAWN
Status Verified Date:
2022-02
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:
After the diagnosis of prostate cancer many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer While there is limited data on the use of diet and supplements to alter the risk of prostate cancer even less is known regarding the ability of diet or supplements to alter progression For men who have elected active surveillance the investigators propose to investigate the ability of vitamin D to retard the growth of prostate cancer
Detailed Description:
Men will be randomized to each of two arms for a total of 24 subjects calcitriol alone DN101 45 micrograms once weekly or placebo Baseline laboratory assays including serum PSA serum and urine calcium and creatinine will be performed and the EPIC questionnaire expanded prostate cancer index composite validated HRQOL tool for prostate cancer patients will be completed Patients will also undergo prostate needle biopsy 4 cores taken under transrectal ultrasound TRUS guidance to establish baseline levels of gene expression Follow-up at the end of 2 weeks just prior to the third dose will include a history and physical and a repeat of all baseline blood and urine tests Follow-up at 3 months will include a history and physical repeating all blood and urine tests and the EPIC questionnaire At 6 months in addition to the history and physical blood and urine tests and the EPIC questionnaire a TRUS-guided prostate needle biopsy will be performed This will be a standard 12-core scheme and 4 of these cores will be used for laboratory analysis Renal ultrasounds will again be performed on men in the calcitriol arms to look for stones Patients who show no evidence of clinical progression will be offered to remain on study in their designated treatment arm for an additional 6 months Any patient exhibiting clinical progression at any time will be withdrawn from the study and offered standard treatment options For patients remaining on study at 12 months an end-of-study biopsy will be requested 12-core scheme with 4 cores used for laboratory analysis
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 |
|---|---|---|---|
| 97408 | OTHER | SU IRB | None |