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Selenium in Preventing Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
high-selenium baker's yeast
selenium
placebo
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer

Eligibility Criteria

undefined - 79 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Arm I

    Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily

    Arm III: 400 μg Se as high-Se baker's yeast daily

    Arm Description

    Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of biopsy-proven prostate cancer

    Secondary Outcome Measures

    Rate of rise in serum PSA levels
    Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A

    Full Information

    First Posted
    September 16, 2009
    Last Updated
    August 13, 2012
    Sponsor
    University of Arizona
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00978718
    Brief Title
    Selenium in Preventing Prostate Cancer
    Official Title
    Phase III Trial of Selenium for Prostate Cancer Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arizona
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    prostate cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
    Arm Title
    Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily
    Arm Type
    Experimental
    Arm Description
    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 Title
    Arm III: 400 μg Se as high-Se baker's yeast daily
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    high-selenium baker's yeast
    Other Intervention Name(s)
    selenium
    Intervention Description
    Given orally
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    selenium
    Intervention Description
    Given orally
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    Given orally
    Primary Outcome Measure Information:
    Title
    Incidence of biopsy-proven prostate cancer
    Secondary Outcome Measure Information:
    Title
    Rate of rise in serum PSA levels
    Title
    Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick R. Ahmann, MD
    Organizational Affiliation
    University of Arizona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Selenium in Preventing Prostate Cancer

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