Vitamin D Effects on Prostate Pathology

Summary

There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when they are scheduled to have their prostate removed because of cancer. The men will take vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from men assigned to the lower doses. We expect to find that the prostate removed at surgery from men who received the high-dose vitamin D treatment will appear more normal, and less cancer like. In addition, we will measure vitamin D metabolites in the prostate to confirm that these did accumulate in the prostate to bring about the effects observed.

Conditions

• Prostate Cancer

Interventions

DIETARY_SUPPLEMENT

vitamin D3 (cholecalciferol)

liquid vitamin D solution (vitamin D3 in ethanol) taken daily at one of three possible doses (400, 10000, or 40000 IU/d) for 4-6 weeks prior to radical prostatectomy

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Canadian Cancer Society (CCS)

  collaborator OTHER

• University of Toronto

  lead OTHER

Principal Investigators

• Reinhold Vieth, PhD · University of Toronto, Mount Sinai Hospital

• Dennis Wagner, MSc · University of Toronto, Mount Sinai Hospital

• Theo van der Kwast, MD, PhD, FRCPC · University Health Network, Toronto

• Neil Fleshner, MD, MPH, FRCSC · University Health Network, Toronto

• Laurence Klotz, MD, FRCSC · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2012-02-29

Completion

2012-07-31

Countries

• Canada

Study Locations