Selenium in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00752739
First received: September 12, 2008
Last updated: August 13, 2012
Last verified: August 2012

September 12, 2008
August 13, 2012
August 2002
April 2007   (final data collection date for primary outcome measure)
  • Rate of rise in serum prostate-specific antigen [ Designated as safety issue: No ]
  • Rate of rise in chromogranin A and alkaline phosphatase [ Designated as safety issue: No ]
  • Disease progression [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00752739 on ClinicalTrials.gov Archive Site
  • Time to prostate cancer therapy [ Designated as safety issue: No ]
  • Time to metastases [ Designated as safety issue: No ]
  • Symptoms of selenium toxicity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Selenium in Treating Patients With Prostate Cancer
Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)

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.

OBJECTIVES:

  • To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.
  • To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.
  • To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.
  • To further establish the safety of chronic supplementation with selenium in these patients.

OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Dietary Supplement: selenium
    Given orally
    Other Name: selenium
  • Other: placebo
    Given orally
  • Placebo Comparator: Arm I
    Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
    Intervention: Other: placebo
  • Experimental: Arm II
    Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
    Intervention: Dietary Supplement: selenium
  • Experimental: Arm III
    Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
    Intervention: Dietary Supplement: selenium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
April 2007
April 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Biopsy-proven adenocarcinoma of the prostate within the past 48 months
  • Prostate-specific antigen < 50 ng/mL
  • Gleason score < 8
  • Currently undergoing "watchful waiting" for prostate cancer
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 3 years
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No other malignancy within the past 5 years, except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer
  • At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day
Male
up to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00752739
97-0395-01, R01CA079080, P30CA023074, UARIZ-97-0395, UARIZ-HSC-97-57, DAMD17-98-1-8580, 97-0395-01
Not Provided
University of Arizona
University of Arizona
National Cancer Institute (NCI)
Principal Investigator: Frederick R. Ahmann, MD University of Arizona
University of Arizona
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP