Clinical trial NCT00030901: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Precancerous/Nonmalignant Condition
Prostate Cancer
Keywords: prostate cancer
high grade prostatic intraepithelial neoplasia
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Eastern Cooperative Oncology Group
name: Cancer and Leukemia Group B
First posted: 2003-01-27
Enrollment: 619
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Presence of Carcinoma of the Prostate as Measured by Biopsy
timeFrame: 3 years
Secondary outcomes:
measure: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
timeFrame: 3 months after randomization and then every 3 months for 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Roswell Park Cancer Institute
name: Jim Marshall, PhD
role: STUDY_CHAIR
affiliation: University of Wisconsin, Madison
name: David Jarrard, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: W. Robert Lee, MD
role: STUDY_CHAIR
References:
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.
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.