THE SEATTLE STUDY: Can repeat prostate biopsy be avoided by the use of a prostate nutritional formula
PRINCIPAL INVESTIGATOR:
Michael Brawer, M.D.
STUDY FORMAT:
A randomized, double blind, placebo controlled study
QUALIFICATION:
1. PSA level between 2.5 ng/ml and 15 ng/ml
2. A negative prostate biopsy
3. Digital rectal exam: inconsistent with prostate cancer
STUDY POPULATION:
A randomized trial with 20 patients in the placebo arm & 20 patients in the prostate nutritional arm
RECORD:
Original PSA reading that prompted the biopsy
PSA reading at 3 months - avoid ejaculation 48 hours prior
PSA reading at 6 months - avoid ejaculation 48 hours prior
NUTRITIONAL PRODUCT AND PLACEBO WILL BE SUPPLIED BY THE PROSTATITIS AND PROSTATE CANCER CENTER
STUDY SPONSOR: THE PROSTATITIS AND PROSTATE CANCER CENTER
STUDY IS COMPLETED AT THIS POINT
OPTIONAL DATA COLLECTION:
AUA symptom score - performed by the same investigator: EPS - performed by the same investigator
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