Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-27 @ 8:56 PM
Study NCT ID:
NCT00887432
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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:
This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.
SECONDARY OBJECTIVES:
I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.
II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
TERTIARY OBJECTIVES:
I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.
II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy \[OH\]) vitamin D response to oral D3 supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
ARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
After completion of study treatment, patients are followed up for 30 days.
I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.
SECONDARY OBJECTIVES:
I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.
II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
TERTIARY OBJECTIVES:
I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.
II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy \[OH\]) vitamin D response to oral D3 supplementation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
ARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
After completion of study treatment, patients are followed up for 30 days.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-01530 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 128308 | OTHER | Roswell Park Cancer Institute | View | |
| P30CA016056 | NIH | None | https://reporter.nih.gov/quic… | View |