Vitamin D in Treating Patients With Prostate Cancer

September 30, 2015 updated by: Roswell Park Cancer Institute

Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

  • To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.
  • To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

  • To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
  • Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
  • Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
  • Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • 25(OH) D3 level < 80 ng/mL

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Creatinine ≤ 2.0 mg/dL
  • Corrected serum calcium ≤ 10.5 mg/dL

Exclusion criteria:

  • History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
  • Hypersensitivity to cholecalciferol or one of its components

PRIOR CONCURRENT THERAPY:

  • No other concurrent vitamin D supplementation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Dietary supplement: cholecalciferol
Given orally
Experimental: Arm II
Patients receive 6,000 IU of vitamin D3 once daily.
Dietary supplement: cholecalciferol
Given orally
Experimental: Arm III
Patients receive 8,000 IU of vitamin D3 once daily.
Dietary supplement: cholecalciferol
Given orally
Experimental: Arm IV
Patients receive 10,000 IU of vitamin D3 once daily.
Dietary supplement: cholecalciferol
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of Response of Serum 25(OH) D3 Levels
Time Frame: Baseline, at 1, 3, 6 months
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Baseline, at 1, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of Response of Parathormone
Time Frame: Baseline, at 1, 3, 6 months
Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Baseline, at 1, 3, 6 months
Toxicity
Time Frame: Baseline, at 1, 3 and 6 months
Number of treated patients that had serious adverse events.
Baseline, at 1, 3 and 6 months
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Time Frame: Baseline, at 1, 3 ,6 months
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls
Baseline, at 1, 3 ,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000562742
  • I 95406 (Other Identifier: Roswell Park Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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