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Vitamin D in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

Patients receive 6,000 IU of vitamin D3 once daily.

Patients receive 8,000 IU of vitamin D3 once daily.

Patients receive 10,000 IU of vitamin D3 once daily.

Outcomes

Primary Outcome Measures

Pattern of Response of Serum 25(OH) D3 Levels
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.

Secondary Outcome Measures

Pattern of Response of Parathormone
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.
Toxicity
Number of treated patients that had serious adverse events.
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls

Full Information

First Posted
August 31, 2007
Last Updated
September 30, 2015
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00524680
Brief Title
Vitamin D in Treating Patients With Prostate Cancer
Official Title
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive 6,000 IU of vitamin D3 once daily.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive 8,000 IU of vitamin D3 once daily.
Arm Title
Arm IV
Arm Type
Experimental
Arm Description
Patients receive 10,000 IU of vitamin D3 once daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Pattern of Response of Serum 25(OH) D3 Levels
Description
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.
Time Frame
Baseline, at 1, 3, 6 months
Secondary Outcome Measure Information:
Title
Pattern of Response of Parathormone
Description
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.
Time Frame
Baseline, at 1, 3, 6 months
Title
Toxicity
Description
Number of treated patients that had serious adverse events.
Time Frame
Baseline, at 1, 3 and 6 months
Title
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Description
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls
Time Frame
Baseline, at 1, 3 ,6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Trump, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Vitamin D in Treating Patients With Prostate Cancer

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