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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pattern of response of serum 25(OH) D3 levels

Outcome Time Frame:

Baseline, at 1, 3, 6 months

Safety Issue:

No

Principal Investigator

Donald L. Trump, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000562742

NCT ID:

NCT00524680

Start Date:

June 2007

Completion Date:

March 2013

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263