CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 35,533 enrolled
Drug / intervention
Vitamin E +3 moredrug
Likely dose
Vitamin E 400 IU daily orally for 7-12 years; Selenium 200 mcg daily for 7-12 yearsAI-extracted
Key inclusion· 6
  • ✓Healthy male volunteers
  • ✓Digital rectal examination (DRE) not suspicious for prostate cancer within 364 days before study entry
  • ✓Total prostate-specific antigen ≤4.0 ng/mL within 364 days before study entry
  • ✓No prior prostate cancer or high-grade prostatic intraepithelial neoplasia
Key exclusion· 7
  • ✕Suspicious DRE for prostate cancer, even if subsequent biopsy is negative
  • ✕History of hemorrhagic stroke
  • ✕Uncontrolled medical illness
  • ✕Retinitis pigmentosa

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006392
NCT00006392Phase 3Completed
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Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated Nov 20, 2015

In Brief

A Phase 3 clinical trial evaluating Vitamin E, Selenium, and 2 other interventions for Prostate Cancer. Completed, enrolled 35,533 participants across 13 sites.

Detailed Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, NCIC Clinical Trials Group

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJul 1, 2001
Primary CompletionMay 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 23.4 years ago

Interventions

Vitamin Edrug

400 IU daily by mouth for 7-12 years

Seleniumdrug

200 mcg daily for 7-12 years

Vitamin E placeboother

daily for 7-12 years

selenium placeboother

daily for 7-12 years