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

NCT00030901 | Completed Phase 3 Results DMC

• 5 other identifiers: CDR0000069210U10CA037429S9917CALGB-70004NCI-P02-0203
• Study Type: interventional
• Target: 619
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Precancerous/Nonmalignant Condition; Prostate Cancer

Keywords

prostate cancer; high grade prostatic intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• Presence of Carcinoma of the Prostate as Measured by Biopsy

  The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.

  3 years

Secondary Outcomes (1)

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

  3 months after randomization and then every 3 months for 3 years

Study Arms (2)

L-selenomethionine

ACTIVE COMPARATOR

L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.

Drug: L-selenomethionine

L-selenomethionine placebo

PLACEBO COMPARATOR

L-selenomethionine placebo one tablet by mouth daily for 3 years

Drug: L-selenomethionine placebo

Interventions

L-selenomethionine DRUG

Randomization between active L-selenomethionine and placebo

Also known as: Selenium

L-selenomethionine

L-selenomethionine placebo DRUG

Randomization between active L-selenomethionine and placebo

Also known as: placebo

L-selenomethionine placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• Cancer and Leukemia Group B: collaborator

Related Publications (2)

• Marshall 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 RESULT

• Sakr 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.

  RESULT

MeSH Terms

Conditions

Precancerous Conditions; Prostatic Neoplasms

Interventions

Selenium

Condition Hierarchy (Ancestors)

Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Jim Marshall, PhD

  Roswell Park Cancer Institute

  STUDY CHAIR

• David Jarrard, MD

  University of Wisconsin, Madison

  STUDY CHAIR

• W. Robert Lee, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2000
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 6, 2013
• Results First Posted: February 6, 2013

Record last verified: 2013-01