Clinical trial NCT00524680: Vitamin D in Treating Patients With Prostate Cancer
Official title: Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 148
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Pattern of Response of Serum 25(OH) D3 Levels
timeFrame: Baseline, at 1, 3, 6 months
Secondary outcomes:
measure: Pattern of Response of Parathormone
timeFrame: Baseline, at 1, 3, 6 months
measure: Toxicity
timeFrame: Baseline, at 1, 3 and 6 months
measure: Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
timeFrame: Baseline, at 1, 3 ,6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Donald L. Trump, MD
role: PRINCIPAL_INVESTIGATOR
References: