Vitamin D in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. | Dietary Supplement: cholecalciferol<br>* Given orally<br>|
| Experimental: Arm II<br>Patients receive 6,000 IU of vitamin D3 once daily. | Dietary Supplement: cholecalciferol<br>* Given orally<br>|
| Experimental: Arm III<br>Patients receive 8,000 IU of vitamin D3 once daily. | Dietary Supplement: cholecalciferol<br>* Given orally<br>|
| Experimental: Arm IV<br>Patients receive 10,000 IU of vitamin D3 once daily. | Dietary Supplement: cholecalciferol<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of Response of Serum 25(OH) D3 Levels | Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | Baseline, at 1, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of Response of Parathormone | Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. | Baseline, at 1, 3, 6 months | 
| Toxicity | Number of treated patients that had serious adverse events. | Baseline, at 1, 3 and 6 months | 
| Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls | Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls | Baseline, at 1, 3 ,6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer