Context:We wanted to investigate vitamin D in low-risk prostate cancer.
Objectives: The objective of the study was to determine whether vitamin D3supplementation at 4000 IU/d for 1 yr is safe and would result in a decrease in serum levels of prostate-specific antigen (PSA) or in the rate of progression.
Design:In this open-label clinical trial (Investigational New Drug 77,839), subjects were followed up until repeat biopsy.
Setting:All subjects were enrolled through the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center, both in Charleston, SC.
Patients and Other Participants:All subjects had a diagnosis of low-risk prostate cancer. Fifty-two subjects were enrolled in the study, 48 completed 1 yr of supplementation, and 44 could be analyzed for both safety and efficacy objectives.
Intervention: The intervention included vitamin D3soft gels (4000 IU).
Main Outcome Measures:Adverse events were monitored throughout the study. PSA serum levels were measured at entry and every 2 months for 1 yr. Biopsy procedures were performed before enrollment (for eligibility) and after 1 yr of supplementation.
Results: No adverse events associated with vitamin D3supplementation were observed. No significant changes in PSA levels were observed. However, 24 of 44 subjects (55%) showed a decrease in the number of positive cores or decrease in Gleason score; five subjects (11%) showed no change; 15 subjects (34%) showed an increase in the number of positive cores or Gleason score.
Conclusion: Patients with low-risk prostate cancer under active surveillance may benefit from vitamin D3 supplementation at 4000 IU/d.
Written by:
Marshall DT, Savage SJ, Garrett-Mayer E, Keane TE, Hollis BW, Horst RL, Ambrose LH, Kindy MS, Gattoni-Celli S. Are you the author?
Departments of Radiation Oncology, Urology, Medicine (Biostatistics), Pediatrics, and Neurosciences, Medical University of South Carolina, Charleston, South Carolina 29425; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina 29401; and Department of Animal Science, Iowa State University, Ames, Iowa 50011.
Reference: J Clin Endocrinol Metab. 2012 Apr 16. Epub ahead of print.
doi: 10.1210/jc.2012-1451
PubMed Abstract
PMID: 22508710