Vitamin D Effects on Prostate Pathology (DProstate)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Mount Sinai Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Reinhold Vieth, University of Toronto
ClinicalTrials.gov Identifier:
NCT00741364
First received: August 25, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: vitamin D3 (cholecalciferol)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • immunohistochemical markers of prostate pathology [ Time Frame: end-of-study ] [ Designated as safety issue: No ]
  • intraprostate vitamin D metabolites [ Time Frame: end-of-study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calcium (serum and urine) [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
  • parathyroid hormone (PTH) [ Time Frame: baseline, final ] [ Designated as safety issue: No ]
  • prostate specific antigen (PSA) [ Time Frame: baseline, final ] [ Designated as safety issue: No ]
  • creatinine (serum and urine) [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
  • phosphate (serum) [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
  • serum vitamin D metabolites [ Time Frame: baseline, final ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
vitamin D3 (400 IU/d)
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
Active Comparator: 2
vitamin D3 (10,000 IU/d)
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
Active Comparator: 3
vitamin D3 (40,000 IU/d)
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

Detailed Description:

Epidemiologic, laboratory, and clinical reports all suggest that vitamin D3 (cholecalciferol) plays a desirable role in the prevention and prognosis of prostate and other cancers. Prostate cancer cells possess both of the enzymes required to convert vitamin D to the active paracrine hormone, calcitriol. However, the dose-response relationship between serum levels of calcidiol (vitamin D status) and prostate tissue levels of calcidiol and calcitriol is yet to be defined. As a neoadjuvant, prior to radical prostatectomy (for 4-6 wk) vitamin D3 [400 IU (control group), 10,000 IU or 40,000 IU/day] will be given to 90 men randomized, double-blinded, 30 per dose. Immediately after surgery, the pathologist will obtain a few grams of prostate tissue, some of which will be used to assay calcidiol and calcitriol within prostate. From the embedded prostate, we will prepare immunohistochemically stained sections to characterize cellular responses and morphological changes. Our hypothesis is that vitamin D will increase intraprostate calcitriol concentration and thereby lower cellular proliferation (as judged by the markers MIB-1 and p27) in zones of Gleason pattern 3 prostate cancer and in pre-cancerous (PIN) lesions. We expect that our results will provide surrogate outcomes to justify larger trials of vitamin D for treatment of prostate cancer. This research has the potential to: 1. Provide direct evidence at the cellular level using clinical samples that vitamin D lowers cellular proliferation in prostate cancer, 2. Provide guidance about the serum calcidiol concentrations (and thereby vitamin D doses) that should be targeted for such studies, and 3. Eventually support other research directed at vitamin D as a primary prevention strategy.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT00741364

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University of Toronto
Mount Sinai Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Reinhold Vieth, PhD University of Toronto, Mount Sinai Hospital
Study Director: Dennis Wagner, MSc University of Toronto, Mount Sinai Hospital
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Reinhold Vieth, Dr. Reinhold Vieth, University of Toronto
ClinicalTrials.gov Identifier: NCT00741364     History of Changes
Other Study ID Numbers: M2140
Study First Received: August 25, 2008
Last Updated: September 29, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
vitamin D
prostate cancer
prostatectomy
pathology
immunohistochemistry

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 August 20, 2014