Prostate Cancer Clinical Trial

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Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.

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Summary

This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.

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Eligibility Criteria

Inclusion Criteria:

lowgrade prostate cancer
serum PSA less than/equal to 10 ng/ml
Gleason score less than/equal to 6
referred from their treating physician with treatment plan of active surveillance for one year
serum creatinine less than/equal to 2.0 mg/dL
serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
serum calcium greater than 8.5 and less than 10.5 mg/dL

Exclusion Criteria:

concurrent malignancy, except non-melanoma skin cancer
history of sarcoidosis
history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
history of hypercalcemia
treatment with lithium medication

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT01045109

Recruitment Status:

Completed

Sponsor:

Medical University of South Carolina

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There is 1 Location for this study

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Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT01045109

Recruitment Status:

Completed

Sponsor:


Medical University of South Carolina

How clear is this clinincal trial information?

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