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: April 23, 2013
Last verified: April 2013
  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 ]

Secondary Outcome Measures:
  • Pattern of response of parathormone [ Time Frame: Baseline, at 1, 3, 6 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Baeline, at 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
  • Occurrence of infections, deep vein thrombosis, vascular events, and falls [ Time Frame: Baseline, at 1, 3 ,6 months ] [ Designated as safety issue: No ]

Enrollment: 128
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 and older
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
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

Additional Information:
No publications provided

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
Last Updated: April 23, 2013
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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 22, 2014