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
  Purpose

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
Prostate Cancer
Dietary Supplement: selenium
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: August 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given orally
Experimental: Arm II
Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: selenium
Given orally
Other Name: selenium
Experimental: Arm III
Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: selenium
Given orally
Other Name: selenium

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752739

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Frederick R. Ahmann, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00752739     History of Changes
Other Study ID Numbers: 97-0395-01, R01CA079080, P30CA023074, UARIZ-97-0395, UARIZ-HSC-97-57, DAMD17-98-1-8580, 97-0395-01
Study First Received: September 12, 2008
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Selenium
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014