Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer (vit D & PCa)
|Prostate Cancer||Drug: vitamin D3 Drug: Placebo daily for one year||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer|
- PSA Slope (Trajectory) or the Change in PSA Level Over Time [ Time Frame: 1 year (visits # 1-8) ]Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.
- Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment [ Time Frame: 1 year ]Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.
|Study Start Date:||January 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3
4,000 IU vitamin D3 daily for one year
Drug: vitamin D3
4,000 IU daily for one year
Placebo Comparator: Placebo
Placebo daily for one year
Drug: Placebo daily for one year
Vitamin D promotes the differentiation of prostate cancer (PCa) 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 PCa to clinical disease. These considerations support the use of vitamin D3 as a chemopreventive agent.
We hypothesize that a daily dose of vitamin D3 (4,000 IU) taken for one year by Veterans diagnosed with low-risk, early-stage PCa, who are eligible for active surveillance will: a) result in a measurable decrease of serum PSA levels in a significant number of enrolled subjects, and b) be associated with a stabilization or improvement of their PCa pathology, as assessed through histological examination of prostate tissue biopsy specimens (Gleason score and percent of positive biopsies) obtained at the end of the study, as part of their standard medical care for active surveillance.
This VA Merit application proposes to conduct a randomized, placebo-controlled clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with early-stage prostate cancer, who elect to have their disease monitored through active surveillance (before considering definitive therapy). The main objectives of this proposed clinical study are as follows:
- To determine whether a daily supplement of 4,000 IU of vitamin D3 taken for twelve months will result in a measurable and significant decrease of serum PSA levels in Veterans diagnosed with low-risk, early stage PCa (Gleason score 6, PSA 10, clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
- To determine in enrolled Veterans the pathology status of their PCa by analyzing prostate tissue biopsy specimens at the end of the study (Gleason score and percentage of positive biopsies), and by comparing them with those obtained before enrollment in this study, as part of their standard medical care.
The implementation of these proposed studies will allow us to assess whether vitamin D3 supplementation can be utilized as a chemopreventive regimen in Veterans diagnosed with low-risk, early stage PCa, and provide a useful addition to active surveillance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953225
|United States, South Carolina|
|Ralph H Johnson VA Medical Center, Charleston|
|Charleston, South Carolina, United States, 29401-5799|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Sebastiano Gattoni-Celli, MD||Ralph H Johnson VA Medical Center, Charleston|