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

January 2, 2013 updated by: Southwest Oncology Group

L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Enrollment (Actual)

619

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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

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

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
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after randomization and then every 3 months for 3 years

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B

Investigators

  • Study Chair: W. Robert Lee, MD, Wake Forest University Health Sciences
  • Study Chair: Jim Marshall, PhD, Roswell Park Cancer Institute
  • Study Chair: David Jarrard, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2000

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

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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