Vitamin D in Treating Patients With Prostate Cancer

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Dietary Supplement: cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00524680

CDR0000562742

I 95406 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 148 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 4 patient groups

Arm I

Experimental group

Description:

Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

Treatment:

Dietary Supplement: cholecalciferol

Arm II

Experimental group

Description:

Patients receive 6,000 IU of vitamin D3 once daily.

Treatment:

Dietary Supplement: cholecalciferol

Arm III

Experimental group

Description:

Patients receive 8,000 IU of vitamin D3 once daily.

Treatment:

Dietary Supplement: cholecalciferol

Arm IV

Experimental group

Description:

Patients receive 10,000 IU of vitamin D3 once daily.

Treatment:

Dietary Supplement: cholecalciferol