S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
Condition: Precancerous/Nonmalignant Condition; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasms; Precancerous Conditions; Prostatic Intraepithelial Neoplasia
Intervention: L-selenomethionine; L-selenomethionine placebo
Intervention description: Randomization between active L-selenomethionine and placebo; Randomization between active L-selenomethionine and placebo
Intervention MeSH terms: Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 619.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: prostate cancer; high grade prostatic intraepithelial neoplasia

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.
    

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