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Study Summary
No. SWOG99-17:.......Prostate......Anita Sabichi......Clinical Cancer Prevention
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Study Summary Title
Study Summary
Number:		SWOG99-17
Study Title:L-SELENIUM-BASED CHEMOPREVENTION OF PROSTATE CANCER AMONG MEN WITH HIGH GRADE PROSTATIC INTRAEPITHELIAL NEOPLASIA.
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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:Clinical Cancer PreventionReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4928
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:N/A
Phase of Study:Phase IIIReturn
Visit:		Every six months.
Treatment
Agents:		SelenomethionineHome Care:n/a
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		The purpose of this study is to determine whether l-selenomethionine (commonly
called selenium) can prevent prostate cancer. This research is being done
because currently there is no way to prevent prostate cancer in patients who
have high grade prostatic intraepithelial neoplasia (HGPIN) and who are at high
risk of developing the disease. Researchers will also measure the level of
prostate specific antigen (PSA) and investigate levels of selenium and other
nutrients (such as vitamins A and E). These tests may help researchers to
better understand how selenium may affect the prostate gland.
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Study Objectives / Outcomes
The principal purpose of this trial is to assess the potential for essential nutrient selenium (Se) to inhibit the progression of prostate cancer.
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Study Status Information
Study Activation / Registration Date:11/13/2001
IRB Review and Approval Date:07/18/2001
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:1,165 (Nationally)
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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:1) 1st Step-Registration Inclusion:*Patient must have had a DRE, TRUS, and a biopsy of the prostate within two years prior to registration that documents high grade PIN with no evidence of cancer. **Patient must have a PSA <or=10ng/ml as determined from a specimen drawn within three months prior to the time of registration. ***Patient must have an AUA symptom score of less than 20 as determined by the Participant Report of Symptoms.****Patient must have performance status of 0-1.

2) 2nd Step - randomization Inclusion: *Patient must be eligible for the 1st Step-Registration in order to go on to the 2nd Step. **Patients must have a repeat biopsy of the prostate (sextant or greater) performed within 3 months prior to Step 2- Randomization. This second biopsy is needed only if the first biopsy included fewer than 10 cores or was performed greather than 6 months prior to registration. This biopsy must be negative for invasive cancer. ***Patient must be Randomized within 6 months of Step 1 - Registration.
Exclusion Criteria:1) *Patients who have taken >or = 50mcg qd selenium daily within 30 days prior to registration are not eligible for this study. Patients must agree not to take supplements containing 50 mcg or more of selenium per day while on study. **The patient must not be taking finasteride (Proscar or Propecia) or any other androgen suppressor. *** No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission.
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Links
Registration Number: NCT00030901
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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