Vitamin D in Treating Patients With Prostate Cancer

Roswell Park Cancer Institute148 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Prostate Cancer

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Given orally

Eligibility

Sex: MALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, at 1, 3, 6 months

Secondary Outcomes

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.

Time frame: Baseline, at 1, 3, 6 months

Toxicity

Number of treated patients that had serious adverse events.

Time frame: 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

Time frame: Baseline, at 1, 3 ,6 months

Data from ClinicalTrials.gov

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