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Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate


Phase 2
30 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

immunohistochemical markers of prostate pathology

Outcome Time Frame:

end-of-study

Safety Issue:

No

Principal Investigator

Reinhold Vieth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Toronto, Mount Sinai Hospital

Authority:

Canada: Health Canada

Study ID:

M2140

NCT ID:

NCT00741364

Start Date:

September 2008

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • vitamin D
  • prostate cancer
  • prostatectomy
  • pathology
  • immunohistochemistry
  • Prostatic Neoplasms

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