Overview

Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

Status:
Completed
Trial end date:
2014-10-30
Target enrollment:
0
Participant gender:
Male
Summary
Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Office of Research and Development
Collaborator:
Medical University of South Carolina
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically
documented adenocarcinoma of the prostate)

- A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or
less in either architectural pattern)

- For the purpose of eligibility, these additional criteria will be verified: *serum
creatinine 2.0 mg/dL

- serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dL

- serum calcium > 8.5 and < 10.5 mg/dL

Exclusion Criteria:

- Subjects with any concurrent malignancy, except non-melanoma skin cancer

- Subjects with a history of sarcoidosis

- Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation

- Subjects with a history of hypercalcemia

- Subjects who use lithium as a medication