Vitamin D Effects on Prostate Pathology

NCT00741364 | Unknown Phase 2

• 1 other identifier: M2140
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitamin D; prostate cancer; prostatectomy; pathology; immunohistochemistry

Outcome Measures

Primary Outcomes (2)

• immunohistochemical markers of prostate pathology

  end-of-study

• intraprostate vitamin D metabolites

  end-of-study

Secondary Outcomes (6)

• calcium (serum and urine)

  biweekly

• parathyroid hormone (PTH)

  baseline, final

• prostate specific antigen (PSA)

  baseline, final

• creatinine (serum and urine)

  biweekly

• phosphate (serum)

  biweekly

Study Arms (3)

1

ACTIVE COMPARATOR

vitamin D3 (400 IU/d)

Dietary Supplement: vitamin D3 (cholecalciferol)

2

ACTIVE COMPARATOR

vitamin D3 (10,000 IU/d)

Dietary Supplement: vitamin D3 (cholecalciferol)

3

ACTIVE COMPARATOR

vitamin D3 (40,000 IU/d)

Dietary Supplement: vitamin D3 (cholecalciferol)

Interventions

vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

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

1; 2; 3

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a Gleason score 6 or 7 adenocarcinoma of the prostate biopsy
• Patient has elected to have a radical prostatectomy
• Patient is determined fit for surgery
• Normal renal and hepatic function
• Normal serum and urine calcium values
• Normal serum phosphate values
• Normal serum parathyroid hormone values
• Signed written informed consent

You may not qualify if:

• Prior use of neoadjuvant androgen deprivation therapy
• Prior use of 5 alpha reductase inhibitors (finasteride or dutasteride) in last 12 months
• Previous or concomitant anti-cancer therapy (chemotherapy, radiotherapy)
• Gleason score 8-10 adenocarcinoma as a biopsy diagnosis
• History of hypercalcemia/hypercalciuria
• History of renal disease
• History of sarcoidosis
• Vitamin D (cholecalciferol) supplement \> 1000 IU/day
• Inability to comply with a study protocol

Sponsors & Collaborators

• University of Toronto: lead
• Mount Sinai Hospital, Canada: collaborator
• University Health Network, Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Reinhold Vieth, PhD

  University of Toronto, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

• Dennis Wagner, MSc

  University of Toronto, Mount Sinai Hospital

  STUDY DIRECTOR

• Theo van der Kwast, MD, PhD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Neil Fleshner, MD, MPH, FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Laurence Klotz, MD, FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Reinhold Vieth

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 30, 2011

Record last verified: 2011-09

Locations

CA (1)