S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Prostate Cancer Clinical Trial

— SELECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006392
• Other study ID #: CDR0000068277
• Secondary ID: S0000U10CA037429
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2000
• Last updated: October 23, 2015
• Start date: July 2001
• Est. completion date: September 2012

Study information

• Verified date: October 2015
• 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. 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.

Description:

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.

Other known NCT identifiers

• NCT00076128

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35533
• Est. completion date: September 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Healthy male volunteers

• Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

• Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer

• Total prostate-specific antigen = 4.0 ng/mL within 364 days prior to study entry

• No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• Systolic blood pressure < 160 mm Hg

• Diastolic blood pressure < 90 mm Hg

• No history of hemorrhagic stroke

Other:

• No malignancies within the past 5 years except basal cell or squamous cell skin cancer

• No uncontrolled medical illness

• No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement

• No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)

• Concurrent multivitamins allowed (supplied on study)

• No concurrent anticoagulation therapy (e.g., warfarin)

• Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

• Concurrent daily aspirin dose = 81 mg for participants receiving clopidogrel

• Concurrent anti-hypertension medication allowed

• No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Vitamin E
400 IU daily by mouth for 7-12 years
• Selenium
200 mcg daily for 7-12 years

Other:
• Vitamin E placebo
daily for 7-12 years
• selenium placebo
daily for 7-12 years

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Good Samaritan Hospital Cancer Treatment Center	Cincinnati	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Midwest Center for Hematology/Oncology	Joliet	Illinois
United States	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	LaFortune Cancer Center at St. John Medical Center	Tulsa	Oklahoma
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Tod Children's Hospital	Youngstown	Ohio

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (7)

Cook ED, Moody-Thomas S, Anderson KB, Campbell R, Hamilton SJ, Harrington JM, Lippman SM, Minasian LM, Paskett ED, Craine S, Arnold KB, Probstfield JL. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials. 2005;2(5):436-42. — View Citation

El-Bayoumy K. The negative results of the SELECT study do not necessarily discredit the selenium-cancer prevention hypothesis. Nutr Cancer. 2009;61(3):285-6. doi: 10.1080/01635580902892829. — View Citation

Hoque A, Albanes D, Lippman SM, Spitz MR, Taylor PR, Klein EA, Thompson IM, Goodman P, Stanford JL, Crowley JJ, Coltman CA, Santella RM. Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control. 2001 Sep;12(7):627-33. — View Citation

Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the — View Citation

Kristal AR, King IB, Albanes D, Pollak MN, Stanzyk FZ, Santella RM, Hoque A. Centralized blood processing for the selenium and vitamin E cancer prevention trial: effects of delayed processing on carotenoids, tocopherols, insulin-like growth factor-I, insulin-like growth factor binding protein 3, steroid hormones, and lymphocyte viability. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):727-30. — View Citation

Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM Jr, Kristal AR, Santella RM, Probstfield JL, Moinpour CM, Albanes D, Taylor PR, Minasian LM, Hoque A, Thomas SM, Crowley JJ, Gaziano JM, Stanford JL, Cook ED, Fleshner NE, Lieber MM, Walther PJ, Khuri FR, Karp DD, Schwartz GG, Ford LG, Coltman CA Jr. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst. 2005 Jan 19;97(2):94-102. — View Citation

Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD 3rd, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Ar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 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.	Every six months for 7 to 12 years depending on when the participant was randomized.	No
Secondary	Number of Participants With Lung Cancer	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 assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.	No
Secondary	Number of Participants With Colorectal Cancer	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 assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.	No
Secondary	Number of Participants With Any Diagnosis of Cancer	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 assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.	No
Secondary	Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival	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 assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.	Yes
Secondary	Number of Participants With Serious Cardiovascular Events	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.	Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.	Yes

External Links

•   Web site for additional information