Phase 3 N=35,533 Randomized Quadruple-blind Prevention

S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00006392 ↗

Enrolled (actual)

35,533

Serious AEs

1.1%

Results posted

Nov 2012

Primary outcome: Primary: Number of Participants With Prostate Cancer — 473; 432; 437; 416 participants — p=< .01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vitamin E (Drug); Selenium (Drug); Vitamin E placebo (Other); selenium placebo (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: SWOG Cancer Research Network
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Prostate Cancer	473; 432; 437; 416	< .01 sig
SECONDARY Number of Participants With Lung Cancer	67; 75; 78; 67	> .05
SECONDARY Number of Participants With Colorectal Cancer	66; 63; 77; 60	> .05
SECONDARY Number of Participants With Any Diagnosis of Cancer	856; 837; 846; 824	> .05
SECONDARY Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival	358; 378; 359; 382; 106; 128	> .05
SECONDARY Number of Participants With Serious Cardiovascular Events	1034; 1080; 1041; 1050	> .05

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00006392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.