Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

All Drugs and Chemicals

Vitamins

Selenium

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

vitamin E and selenium placebo daily for 7-12 years

selenium and vitamin E placebo daily for 7-12 years

vitamine E placebo and selenium placebo daily for 7-12 years

Vitamin E placebo

selenium placebo

Eric Klein, MD

Philip J. Walther, MD, PhD

Laurence H. Klotz, MD

Scott M. Lippman, M.D.

Ian M. Thompson, M.D.

J. Michael Gaziano, M.D.

Daniel D Karp, M.D.

Fadlo R. Khuri, M.D.

Michael M Lieber, M.D.

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.

OBJECTIVES:

* Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
* Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
* Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.

S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Cancer and Leukemia Group B

NCIC Clinical Trials Group

SWOG Cancer Research Network

Study site visits, collected by CRA based on participant interview and annual limited physical exam

Selenium Alone

Combination

Placebo for selenium + placebo for vitamin E

Placebo

Vitamin E Alone

Vitamin E + matching placebo for selenium

Selenium + matching placebo for vitamin E

Matching placebo for vitamin E + matching placebo for selenium

Total

Age, Continuous

Sex: Female, Male

White

African American

Hispanic (non-African American)

Hispanic (African American)

Other

Race/Ethnicity, Customized

United States

Canada

Puerto Rico

Region of Enrollment

50 - 54 years

55 - 64 years

65 - 74 years

>= 75 years

Age (categorical)

<= High school graduate or GED

Some college/vocational school

>= College graduate

Unknown/missing

Education (highest)

0.1 - 1.0

1.1 - 2.0

2.1 - 3.0

3.1 - 4.0

> 4.0

PSA (ng/ml)

Never

Current

Former

Ever (unknown status)

Unknown

Smoking status

Study Statistician

Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.

Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.

All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.

Number of Participants With Prostate Cancer

All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.

Number of Participants With Lung Cancer

The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.

Number of Participants With Colorectal Cancer

The power to look at all cancer incidence is greater than 90%.

Number of Participants With Any Diagnosis of Cancer

Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.

All deaths

All cancer deaths

Prostate cancer deaths

Lung cancer deaths

Colorectal cancer deaths

All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.

Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival

Number of Participants With Serious Cardiovascular Events

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
S0000 Selenium and Vitamin E in Preventing Prostate Cancer	NCT00006392	Prostate Cancer	Vitamin E Selenium Vitamin E place... selenium placeb...	50 Years - 120 Years	SWOG Cancer Research Network
S0000 Selenium and Vitamin E in Preventing Prostate Cancer	NCT00006392	Prostate Cancer	Vitamin E Selenium Vitamin E place... selenium placeb...	50 Years - 120 Years	SWOG Cancer Research Network

Spots Global Cancer Trial Database for vitamin e placebo