CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0131 (clinicaltrials.gov NCT No: NCT00731848)
Title:An Open Label 48-Month Extension Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels
Principal Investigator:Curtis A. Pettaway
Treatment Agent:pomegranate extract
Study Status:Closed
Study Description:The goal of this clinical research study is to see if pomegranate liquid
extract juice can lower PSA levels or stop PSA levels from getting higher in
patients who have previously received a placebo in another study by the same
sponsor.

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Disease Group:Prostate
Phase of Study:N/A
Treatment Agents:pomegranate extract
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:N/A
Supported By:Roll International
Return Visit:Subjects will return to the clinic every 3 months for PSA level assessments for
up to 48 months. Each participant will receive reimbursement of $25.00 per
follow-up visit, to help with travel reimbursement.
Home Care:Subjects will drink 8 ounces of pomegranate liquid extract juice daily for 48
months. Study product will be shipped to them weekly. Patients will also
complete a diary to report the consumption of the product.


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Physician Name:Curtis A. Pettaway
Dept:Urology
For Clinical Trial Enrollment:713-792-3250
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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