Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation - Full Text View

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00887432

Purpose

RATIONALE: Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.

PURPOSE: This randomized clinical trial is studying how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation.

Condition	Intervention
Prostate Cancer	Dietary Supplement: cholecalciferol Other: placebo

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

Drug Information available for: Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Change in PSA velocity, doubling time, and slope [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pattern of response of PSA dynamics and absolute change in PSA [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	April 2009
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity.	Dietary Supplement: cholecalciferol Given orally Other: placebo Given orally
Arm II: Experimental Patients receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity.	Dietary Supplement: cholecalciferol Given orally Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

To determine the change in PSA velocity, doubling time, and slope after treatment with oral high-dose cholecalciferol (vitamin D3) supplementation in patients with localized adenocarcinoma of the prostate undergoing active surveillance.

Secondary

To examine the pattern of response of PSA dynamics as well as the absolute change in PSA after treatment with this regimen.
To assess the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to Gleason score (≤ 6 vs > 6) and season of study entry (winter/spring vs summer/fall). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Clinically localized disease
Has chosen to undergo active surveillance
Has ≥ 3 PSA values available that were obtained within the past 9-18 months
PSA slope > 0 within the past 18 months
25-hydroxy D3 level < 80 ng/mL within the past 3 months

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Creatinine ≤ 2.0 mg/dL
Corrected serum calcium ≤ 10.5 mg/dL
No history of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
No history of nephrolithiasis

PRIOR CONCURRENT THERAPY:

No prior or other concurrent therapy for prostate cancer
No other concurrent vitamin D supplementation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887432

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Donald L. Trump, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute ( Donald L. Trump )
Study ID Numbers:	CDR0000640525, RPCI-I-128308
Study First Received:	April 23, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00887432 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Cholecalciferol
Prostatic Diseases
Genital Neoplasms, Male
Vitamins
Bone Density Conservation Agents
Trace Elements

Urogenital Neoplasms
Micronutrients
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Cholecalciferol
Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms

Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vitamins
Micronutrients
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009