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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00752739 |
RATIONALE: Selenium may prevent or slow the growth of prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Dietary Supplement: selenium Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control |
Official Title: | Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial) |
Estimated Enrollment: | 220 |
Study Start Date: | September 1998 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Placebo Comparator
Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
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Other: placebo
Given orally
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Arm II: Experimental
Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
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Dietary Supplement: selenium
Given orally
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Arm III: Experimental
Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
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Dietary Supplement: selenium
Given orally
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OBJECTIVES:
OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.
Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.
Patients complete urological symptom questionnaires and other questionnaires periodically.
Ages Eligible for Study: | up to 85 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Frederick R. Ahmann, MD 800-243-6519 rahmann@azcc.arizona.edu |
Principal Investigator: | Frederick R. Ahmann, MD | University of Arizona |
Responsible Party: | Arizona Cancer Center at University of Arizona Health Sciences Center ( Frederick R. Ahmann ) |
Study ID Numbers: | CDR0000614471, UARIZ-97-0395, UARIZ-HSC-97-57 |
Study First Received: | September 12, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00752739 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Selenium Antioxidants Prostatic Diseases Genital Neoplasms, Male Trace Elements |
Urogenital Neoplasms Micronutrients Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antioxidants Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Trace Elements |
Genital Diseases, Male Protective Agents Pharmacologic Actions Selenium Neoplasms Neoplasms by Site Micronutrients Prostatic Neoplasms |