Prostate Cancer Clinical Trial

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Vitamin D in Treating Patients With Prostate Cancer

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Summary

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.

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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

148

Study ID:

NCT00524680

Recruitment Status:

Completed

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

148

Study ID:

NCT00524680

Recruitment Status:

Completed

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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