Selenium in Preventing Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Other: placebo; Dietary Supplement: selenium; Dietary Supplement: high-selenium baker's yeast

• Registration Number: NCT00978718
• Lead Sponsor: University of Arizona

Brief Summary

RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer.

PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.

Detailed Description

OBJECTIVES:

* To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.

* To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

* Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

* Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	placebo	Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily	selenium	Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Arm III: 400 μg Se as high-Se baker's yeast daily	high-selenium baker's yeast	Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Primary Outcome Measures

Name	Time	Method
Incidence of biopsy-proven prostate cancer

Secondary Outcome Measures

Name	Time	Method
Rate of rise in serum PSA levels
Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A