Status:
UNKNOWN
Vitamin D Effects on Prostate Pathology
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Mount Sinai Hospital, Canada
University Health Network, Toronto
Conditions:
Prostate Cancer
Eligibility:
MALE
30-85 years
Phase:
PHASE2
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...
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 cell...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00741364
Start Date
September 1 2008
End Date
July 1 2012
Last Update
September 30 2011
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4