Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial

• Status: Completed
• Trial end date: 2020-05-11
• Target enrollment: 0
• Participant gender: Male

Summary

Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin D3 supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).

• 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 19 - 90 years old - Low-grade prostate cancer

• Clinical Stage T1C or T2a

• Serum PSA < 10.0 ng/ml

• Gleason Score < or = to 6 (either architectural pattern < or = to 3)

• Decision to monitor prostate cancer in Active Surveillance

• Serum creatinine < 2.0 mg/dL

• Serum phosphorus > 2.3 and < 4.8 mg/dL

• Serum calcium > 8.5 and < 10.5 mg/dL

• Must be capable of giving consent to participate in the study

Exclusion Criteria:

• Any concurrent malignancy, except non-melanoma skin cancer

• History of sarcoidosis

• History of Primary Hyperparathyroidism

• History of hypercalcemia

• Vitamin D supplementation > 2,000 IU daily

• Lithium medication