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Study Summary
No. SWOG98-12:.............Anita Sabichi......Cancer Prevention
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Study Summary Title
Study Summary
Number:		SWOG98-12
Study Title:Pilot Study of l-Selenomethionine in Prostate Cancer Patients Scheduled to Undergo Radical Prostatectomy
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Physician New Patient Referral
Name:Anita SabichiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Cancer PreventionReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-5437
Contact us about clinical trials
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General Information
Disease Group:Supported By:N/A
Phase of Study:Return
Visit:		Patients will be seen by the Urology or Medical Oncology faculty for
preliminary evaluation and will be seen again for surgical resection. Interim
visits will depend on the clinical indications and are not a protocol
requirement.
Treatment
Agents:		Home Care:For participants randomized to receive selenium, the drug is taken by mouth at
home. Pill diaries will be given with prescription instructions.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		Inpatient hospitalization is not expected as a part of the study.
Hospitalization my be required for the prostatectomy.
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
A. The primary objective of this randomized trial is to compare prostate tissue selenium levels for two groups of prostate cancer patients at the time of radical prostatectomy. One group (selenium supplement arm) will be pretreated with oral l-selenomethionine; the observation arm will not.
B. The secondary objective is to compare the two groups with respect to the following outcomes:
    a. Prostate tissue levels of the selenoprotein glutathione peroxide Se (SeGPx) (in normal and cancer tissue);
    b. Prostate tissue levels of the selenoprotein thioredoxin reductase (TR) (in normal and cancer tissue);
    c. Prostate tissue apoptosis (cancer tissue);
    d. Prostate tissue levels of 8-hydroxy-2deoxy-guanosine (8-OH-dG).
C. To assess toxicity associated with one month's supplementation of l-selenomethionine in this patient population.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:05/05/2005
Study Type:
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:Unavailable
Exclusion Criteria:Unavailable
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Links
Registration Number: Not Applicable Clinical Trial
Other Links:
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Results

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