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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00030901
First received: February 14, 2002
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Presence of Carcinoma of the Prostate as Measured by Biopsy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 619
Study Start Date: February 2000
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030901

Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: Jim Marshall, PhD Roswell Park Cancer Institute
Study Chair: David Jarrard, MD University of Wisconsin, Madison
Study Chair: W. Robert Lee, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
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.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00030901     History of Changes
Other Study ID Numbers: CDR0000069210, U10CA037429, S9917, CALGB-70004, NCI-P02-0203
Study First Received: February 14, 2002
Results First Received: November 19, 2012
Last Updated: January 2, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:
Selenium
Precancerous Conditions
Prostatic Intraepithelial Neoplasia
Prostatic Neoplasms
Carcinoma
Carcinoma in Situ
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014