Selenium in Preventing Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00978718
First received: September 16, 2009
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer.

PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: high-selenium baker's yeast
Dietary Supplement: selenium
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase III Trial of Selenium for Prostate Cancer Prevention

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Incidence of biopsy-proven prostate cancer [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of rise in serum PSA levels [ Designated as safety issue: No ]
  • Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: August 2001
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I
Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Other: placebo
Given orally
Experimental: Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily
Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Dietary Supplement: selenium
Given orally
Experimental: Arm III: 400 μg Se as high-Se baker's yeast daily
Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Dietary Supplement: high-selenium baker's yeast
Given orally
Other Name: selenium

Detailed Description:

OBJECTIVES:

  • To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.
  • To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
  • Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
  • Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).

  Eligibility

Ages Eligible for Study:   up to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:

    • PSA level above the absolute value of 4 ng/mL or above a published age-ethnic adjusted PSA level appropriate for the community
    • Rising PSA that should represent a clinically significant PSA velocity (e.g., an estimated annual change in the PSA velocity ≥ 0.75 ng/mL)
    • Abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
    • Documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
  • Prostate biopsy negative for cancer within the past 12 months
  • Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN)

    • PIN allowed provided it is grade 1

PATIENT CHARACTERISTICS:

  • Creatinine < 2 times upper limit of normal (ULN)
  • Bilirubin < 2 times ULN
  • SGOT and SGPT < 2 times ULN
  • Alkaline phosphatase < 2 times ULN
  • No history of a prior malignancy except for the following:

    • Adequately treated basal cell or squamous cell carcinoma
    • Adequately treated (i.e., complete surgical removal with negative margins) stage I cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy or radiotherapy
  • At least 90 days since prior and no other concurrent selenium > 55 μg/day as a dietary supplement (including multivitamin supplements)
  • More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978718

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: NCT00978718     History of Changes
Other Study ID Numbers: 01-0506-01, R01CA077789, P30CA023074, UARIZ-99-0045-01,
Study First Received: September 16, 2009
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
prostate cancer

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

ClinicalTrials.gov processed this record on August 18, 2014