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Vitamin D in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524680
First received: August 31, 2007
Last updated: September 30, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: cholecalciferol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Pattern of Response of Serum 25(OH) D3 Levels [ Time Frame: Baseline, at 1, 3, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, at 1, 3, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, at 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
    Number of treated patients that had serious adverse events.

  • Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls [ Time Frame: Baseline, at 1, 3 ,6 months ] [ Designated as safety issue: No ]
    Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls


Enrollment: 148
Study Start Date: June 2007
Study Completion Date: March 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524680

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524680     History of Changes
Other Study ID Numbers: CDR0000562742  I 95406 
Study First Received: August 31, 2007
Results First Received: March 17, 2015
Last Updated: September 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2016