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S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030901
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 6, 2013
Last Update Posted : February 6, 2013
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.

PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.

Condition or disease Intervention/treatment Phase
Precancerous/Nonmalignant Condition Prostate Cancer Drug: L-selenomethionine Drug: L-selenomethionine placebo Phase 3

Detailed Description:


  • Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
  • Compare the toxicity of these regimens in these patients.
  • Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
  • Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive oral selenium once daily.
  • Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 8 years.

PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 619 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
Study Start Date : February 2000
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: L-selenomethionine
L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.
Drug: L-selenomethionine
Randomization between active L-selenomethionine and placebo
Other Name: Selenium

Placebo Comparator: L-selenomethionine placebo
L-selenomethionine placebo one tablet by mouth daily for 3 years
Drug: L-selenomethionine placebo
Randomization between active L-selenomethionine and placebo
Other Name: placebo

Primary Outcome Measures :
  1. Presence of Carcinoma of the Prostate as Measured by Biopsy [ Time Frame: 3 years ]
    The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.

Secondary Outcome Measures :
  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: 3 months after randomization and then every 3 months for 3 years ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of cancer

    • Documented by a digital rectal exam and biopsy of the prostate with transrectal ultrasound guidance (required if fewer than 6 cores obtained in biopsy) meeting one of the following conditions:

      • Biopsy yielded fewer than 10 cores within the past 24 months OR yielded more than 10 cores 6-24 months before study
      • Biopsy yielded 10 or more cores within the past 6 months
  • PSA ≤ 10 ng/mL (≤ 5 ng/mL for patients who have received finasteride or other androgen suppressor within the past 2 months)
  • American Urological Association symptom score of less than 20



  • 40 and over

Performance status:

  • SWOG 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer that is in complete remission


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • No concurrent finasteride or any other androgen suppressor


  • Not specified


  • Not specified


  • At least 30 days since prior daily dietary supplements containing 50 micrograms or more of selenium
  • No concurrent daily dietary supplements containing more than 50 micrograms of selenium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030901

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
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Study Chair: Jim Marshall, PhD Roswell Park Cancer Institute
Study Chair: David Jarrard, MD University of Wisconsin, Madison
Study Chair: W. Robert Lee, MD Wake Forest University Health Sciences

Publications of Results:
Sakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004.

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Responsible Party: Southwest Oncology Group Identifier: NCT00030901    
Other Study ID Numbers: CDR0000069210
U10CA037429 ( U.S. NIH Grant/Contract )
S9917 ( Other Identifier: SWOG )
CALGB-70004 ( Other Identifier: CALGB )
NCI-P02-0203 ( Other Identifier: NCI grant )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: February 6, 2013
Last Update Posted: February 6, 2013
Last Verified: January 2013
Keywords provided by Southwest Oncology Group:
prostate cancer
high grade prostatic intraepithelial neoplasia
Additional relevant MeSH terms:
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Prostatic Neoplasms
Precancerous Conditions
Prostatic Intraepithelial Neoplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances