Clinical trial · Interventional

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

L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia

NCT00030901CI-TRIAL-00009335completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Precancerous/Nonmalignant Condition	—	UNRESOLVED	—
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
L-selenomethionine	Drug	—	UNRESOLVED
L-selenomethionine placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
L-selenomethionine
description
L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.
interventionNames
1. Drug: L-selenomethionine
type
PLACEBO_COMPARATOR
label
L-selenomethionine placebo
description
L-selenomethionine placebo one tablet by mouth daily for 3 years
interventionNames
1. Drug: L-selenomethionine placebo

Primary outcomes (1)

measure
Presence of Carcinoma of the Prostate as Measured by Biopsy
timeFrame
3 years

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 40 Years

Show eligibility criteria text

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

References

Publications (2)

RESULTMarshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84. doi: 10.1158/1055-9965.EPI-05-0585. PMID 16896036
RESULTSakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004.