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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030901
• Other study ID #: CDR0000069210
• Secondary ID: U10CA037429S9917
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2002
• Last updated: January 2, 2013
• Start date: February 2000
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Prostate Cancer
• Prostatic Intraepithelial Neoplasia
• Prostatic Neoplasms

Intervention

Drug:
• L-selenomethionine
Randomization between active L-selenomethionine and placebo
• L-selenomethionine placebo
Randomization between active L-selenomethionine and placebo

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Southwest Oncology Group	Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

References & Publications (2)

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 — View 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 Amer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years	No
Secondary	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.	3 months after randomization and then every 3 months for 3 years	Yes