Phase 3 N=619 Randomized Triple-blind Prevention

S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate

Precancerous/Nonmalignant Condition · Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00030901 ↗

Enrolled (actual)

619

Serious AEs

3.2%

Results posted

Feb 2013

Primary outcome: Primary: Presence of Carcinoma of the Prostate as Measured by Biopsy — 48; 49 participants — p=0.73

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: L-selenomethionine (Drug); L-selenomethionine placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: SWOG Cancer Research Network
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of Carcinoma of the Prostate as Measured by Biopsy	48; 49	0.73
SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	0; 1; 0; 1; 1; 0	—

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate. PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of cancer
Documented by a digital rectal exam and biopsy of the prostate with transrectal ultrasound guidance (required if fewer than 6 cores obtained in biopsy) meeting one of the following conditions:
Biopsy yielded fewer than 10 cores within the past 24 months OR yielded more than 10 cores 6-24 months before study
Biopsy yielded 10 or more cores within the past 6 months
PSA ≤ 10 ng/mL (≤ 5 ng/mL for patients who have received finasteride or other androgen suppressor within the past 2 months)
American Urological Association symptom score of less than 20

PATIENT CHARACTERISTICS:

Age:

40 and over

Performance status:

SWOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics
No concurrent finasteride or any other androgen suppressor

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 30 days since prior daily dietary supplements containing 50 micrograms or more of selenium
No concurrent daily dietary supplements containing more than 50 micrograms of selenium

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00030901). 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.