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Vitamin D Effects on Prostate Pathology

NCT ID: NCT00741364

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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vitamin D prostate cancer prostatectomy pathology immunohistochemistry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

vitamin D3 (400 IU/d)

Group Type ACTIVE_COMPARATOR

vitamin D3 (cholecalciferol)

Intervention Type 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

2

vitamin D3 (10,000 IU/d)

Group Type ACTIVE_COMPARATOR

vitamin D3 (cholecalciferol)

Intervention Type 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

3

vitamin D3 (40,000 IU/d)

Group Type ACTIVE_COMPARATOR

vitamin D3 (cholecalciferol)

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Reinhold Vieth

Dr. Reinhold Vieth

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reinhold Vieth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Mount Sinai Hospital

Dennis Wagner, MSc

Role: STUDY_DIRECTOR

University of Toronto, Mount Sinai Hospital

Theo van der Kwast, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Neil Fleshner, MD, MPH, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Laurence Klotz, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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M2140

Identifier Type: -

Identifier Source: org_study_id