Selenium in Preventing Prostate Cancer

August 13, 2012 updated by: University of Arizona

Phase III Trial of Selenium for Prostate Cancer Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 79 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • selenium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of biopsy-proven prostate cancer

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

June 1, 2004

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (ESTIMATE)

September 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0506-01
  • P30CA023074 (U.S. NIH Grant/Contract)
  • R01CA077789 (NIH)
  • UARIZ-99-0045-01, (OTHER: CDR0000654651)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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