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Phase III Trial Of Toremifene In High-Grade Prostatic Intraepithelial Now
Open For Registration
(April 2005)
Encouraging results
of a Phase IIB trial comparing the selective > estrogen receptor modifier
(SERM), toremifene (20 mg, po, qd), to a placebo reported a significant
reduction of prostate cancer risk at one year (24.4% vs 31.2%) in a study
of 514 men with HGPIN. A full discussion of this issue appeared in the PCa
Commentary, January 2005 (An electronic
archive copy can be found on the SPI website – seattleprostate.com /
Physician Education / PCa Commentary / Diagnostics – “High Grade Prostatic
Intraepithelial Neoplasia Is A Disease".)
Dr. Lilly, urologist, Swedish Hospital, Seattle, is the local
principal investigator for the now open phase III, randomized
double-blind, placebo controlled trial sponsored by the GTX Corp., the
maker of apodene" (toremifene). Eligibility requires that applicants have
a biopsy within the prior 6 months negative for cancer and showing HGPIN.
Concomitant atypia (ASAP) is permitted.The PSA level may not be higher
than 12 ng/mL. During the 18 month study repeat biopsies will be done at
12 and 18 months. All pathology will be reviewed by Dr. Bostwick. For
further information and registration contact Dr. Lilly his office phone,
206-292-6488, or email at jlilly@seattleurological.org.
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