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


Phase 3
50 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Prostate Cancer

Outcome Description:

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.

Outcome Time Frame:

Every six months for 7 to 12 years depending on when the participant was randomized.

Safety Issue:

No

Principal Investigator

Eric Klein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068277

NCT ID:

NCT00006392

Start Date:

July 2001

Completion Date:

December 2016

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Tod Children's HospitalYoungstown, Ohio  44501
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
LaFortune Cancer Center at St. John Medical CenterTulsa, Oklahoma  74104
Bethesda North HospitalCincinnati, Ohio  45242
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220