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

Primary Purpose

Precancerous/Nonmalignant Condition, Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
L-selenomethionine
L-selenomethionine placebo
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous/Nonmalignant Condition focused on measuring prostate cancer, high grade prostatic intraepithelial neoplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    L-selenomethionine

    L-selenomethionine placebo

    Arm Description

    L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.

    L-selenomethionine placebo one tablet by mouth daily for 3 years

    Outcomes

    Primary Outcome Measures

    Presence of Carcinoma of the Prostate as Measured by Biopsy
    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
    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.

    Full Information

    First Posted
    February 14, 2002
    Last Updated
    January 2, 2013
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00030901
    Brief Title
    S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
    Official Title
    L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2000 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Precancerous/Nonmalignant Condition, Prostate Cancer
    Keywords
    prostate cancer, high grade prostatic intraepithelial neoplasia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    619 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    L-selenomethionine
    Arm Type
    Active Comparator
    Arm Description
    L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.
    Arm Title
    L-selenomethionine placebo
    Arm Type
    Placebo Comparator
    Arm Description
    L-selenomethionine placebo one tablet by mouth daily for 3 years
    Intervention Type
    Drug
    Intervention Name(s)
    L-selenomethionine
    Other Intervention Name(s)
    Selenium
    Intervention Description
    Randomization between active L-selenomethionine and placebo
    Intervention Type
    Drug
    Intervention Name(s)
    L-selenomethionine placebo
    Other Intervention Name(s)
    placebo
    Intervention Description
    Randomization between active L-selenomethionine and placebo
    Primary Outcome Measure Information:
    Title
    Presence of Carcinoma of the Prostate as Measured by Biopsy
    Description
    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.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
    Description
    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.
    Time Frame
    3 months after randomization and then every 3 months for 3 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jim Marshall, PhD
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    David Jarrard, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    W. Robert Lee, MD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16896036
    Citation
    Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84. doi: 10.1158/1055-9965.EPI-05-0585.
    Results Reference
    result
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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