Phase 2
N=83
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00953225 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: PSA Slope (Trajectory) or the Change in PSA Level Over Time — 0.59; 0.27 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vitamin D3 (Drug); Placebo daily for one year (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PSA Slope (Trajectory) or the Change in PSA Level Over Time |
0.59; 0.27 | — |
| SECONDARY Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment |
-1.00; 0.00 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00953225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.