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NCT Number: NCT00524680

Vitamin D in Treating Patients With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

Given orally

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Toxicity

    Time frame: Baseline, at 1, 3 and 6 months

    Number of treated patients that had serious adverse events.

  3. 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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Sep 3, 2007
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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