Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Summary
RATIONALE: Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.
PURPOSE: This randomized clinical trial is studying how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation.
Description
OBJECTIVES:
Primary
- To determine PSA response with oral high-dose vitamin D3 supplementation in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.
Secondary
- To examine the pattern of response of PSA dynamics as well as the absolute change in PSA after treatment with this regimen.
- To assess the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to Gleason score (≤ 6 vs > 6) and season of study entry (winter/spring vs summer/fall). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients then receive oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
cholecalciferol, placebo
Location
Roswell Park Cancer Institute
Buffalo
New York
United States
14263-0001
Status
Recruiting
Source
Roswell Park Cancer Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00887432
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prostate-specific Antigen
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Fenretinide
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Prostatic Secretory Proteins
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
Prostatic Neoplasms
Tumors or cancer of the PROSTATE.
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