Vitamin D in Treating Patients With Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | June 2007 |
| End Date: | March 2013 |
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D
works in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D
works in treating patients with prostate cancer.
OBJECTIVES:
Primary
- To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol
(vitamin D3) supplementation at four different oral doses in patients with prostate
cancer.
Secondary
- To examine the pattern of response of parathormone (PTH) following vitamin D3
supplementation in these patients.
- To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
Tertiary
- To track occurrence of infections, deep vein thrombosis, vascular events, and falls in
these patients.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
- Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
- Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
- Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms
continues for 6 months in the absence of disease progression or unacceptable toxicity.
Primary
- To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol
(vitamin D3) supplementation at four different oral doses in patients with prostate
cancer.
Secondary
- To examine the pattern of response of parathormone (PTH) following vitamin D3
supplementation in these patients.
- To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
Tertiary
- To track occurrence of infections, deep vein thrombosis, vascular events, and falls in
these patients.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
- Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
- Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
- Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms
continues for 6 months in the absence of disease progression or unacceptable toxicity.
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- 25(OH) D3 level < 80 ng/mL
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Corrected serum calcium ≤ 10.5 mg/dL
Exclusion criteria:
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or
tropical sprue)
- Hypersensitivity to cholecalciferol or one of its components
PRIOR CONCURRENT THERAPY:
- No other concurrent vitamin D supplementation
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