S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | February 14, 2002 | ||||||||||||
Last Updated Date | July 21, 2011 | ||||||||||||
Start Date ICMJE | February 2000 | ||||||||||||
Primary Completion Date | |||||||||||||
Current Primary Outcome Measures ICMJE |
Presence or absence of carcinoma of the prostate as measured by biopsy [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Presence or absence of carcinoma of the prostate as measured by biopsy | ||||||||||||
Change History | Complete list of historical versions of study NCT00030901 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE | |||||||||||||
Original Secondary Outcome Measures ICMJE | |||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | S9917, Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate | ||||||||||||
Official Title ICMJE | L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia | ||||||||||||
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. |
||||||||||||
Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.
Patients are followed every 6 months for 2 years and then annually for 8 years. PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study. |
||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 3 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
||||||||||||
Condition ICMJE |
|
||||||||||||
Intervention ICMJE | Dietary Supplement: selenium | ||||||||||||
Study Arm (s) | |||||||||||||
Publications * |
|
||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
Estimated Enrollment ICMJE | 465 | ||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||||||||||
Gender | Male | ||||||||||||
Ages | 40 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00030901 | ||||||||||||
Other Study ID Numbers ICMJE | CDR0000069210, U10CA032102, S9917, CALGB-70004, S9917, NCI-P02-0203 | ||||||||||||
Has Data Monitoring Committee | |||||||||||||
Responsible Party | Laurence H. Baker, D.O., Chairman, SWOG | ||||||||||||
Study Sponsor ICMJE | Southwest Oncology Group | ||||||||||||
Collaborators ICMJE |
|
||||||||||||
Investigators ICMJE |
|
||||||||||||
Information Provided By | Southwest Oncology Group | ||||||||||||
Verification Date | July 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |