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

Phase 3
40 Years
Not Enrolling
Precancerous/Nonmalignant Condition, Prostate Cancer

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Trial Information

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


- 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.

Inclusion Criteria


- Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of

- 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



- 40 and over

Performance status:

- SWOG 0-1

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- See Disease Characteristics

- No concurrent finasteride or any other androgen suppressor


- Not specified


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Presence of Carcinoma of the Prostate as Measured by Biopsy

Outcome 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.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jim Marshall, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

November 2011

Related Keywords:

  • Precancerous/Nonmalignant Condition
  • Prostate Cancer
  • prostate cancer
  • high grade prostatic intraepithelial neoplasia
  • Neoplasms
  • Precancerous Conditions
  • Prostatic Neoplasms
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ