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Phase III Randomized Study of Selenium as Chemoprevention of Prostate Cancer in Patients With High-Grade Prostatic Intraepithelial Neoplasia
Last Modified: 9/5/2008     First Published: 2/1/2002  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIPreventionClosed40 and overNCISWOG-S9917
CALGB-70004, ECOG-SWOG-S9917, NCI-P02-0203, NCT00030901

Objectives

  1. Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
  2. Compare the toxicity of these regimens in these patients.
  3. Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
  4. 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.

Entry Criteria

Disease Characteristics:

  • 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


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

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

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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

Patient Characteristics:

Age:

  • 40 and over

Performance status:

  • SWOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • 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

Expected Enrollment

465

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

Outcomes

Primary Outcome(s)

Presence or absence of carcinoma of the prostate as measured by biopsy

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.

Published Results

Marshall JR, Sakr W, Wood D, et al.: Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev 15 (8): 1479-84, 2006.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Jim Marshall, PhD, Protocol chair
Ph: 716-845-8444; 800-685-6825

Eastern Cooperative Oncology Group

David Jarrard, MD, Protocol chair
Ph: 608-263-8600; 800-622-8922
Email: jarrard@surgery.wisc.edu

Cancer and Leukemia Group B

W. Robert Lee, MD, Protocol chair
Ph: 336-713-6505; 800-446-2255

Related Information

Featured trial article 1

Registry Information
Official Title L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
Trial Start Date 2000-02-01
Registered in ClinicalTrials.gov NCT00030901 2
Date Submitted to PDQ 2001-12-28
Information Last Verified 2006-12-19
NCI Grant/Contract Number CA32102

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://www.cancer.gov/clinicaltrials/ft-SWOG-S9917
2http://clinicaltrials.gov/ct/show/NCT00030901