AUA 2011 - Men with isolated high grade prostatic intraepithelial neoplasia (HGPIN) have a high risk of prostate cancer in long-term follow-up: Results from a prospective multicenter, randomized, placebo-controlled prostate cancer prevention trial - Sessi

WASHINGTON, DC USA (UroToday.com) - Men with isolated HGPIN are at high risk for the development of prostate cancer and should be aggressively monitored with follow-up PSA and prostate needle biopsy, according to work by Dr. Samir Taneja and colleagues.

There has been controversy about whether men diagnosed with HGPIN on biopsy have a higher risk of subsequent prostate cancer (CaP) than men with benign biopsies. It’s reported that the median risk for the development of CaP in men diagnosed with HGPIN was 24.1%, and in two recent CaP prevention trials, CaP was diagnosed in 24.4% and 24.9% of men with benign biopsies, he said. These investigators examined the placebo group from a large CaP prevention trial in men with isolated HGPIN. A total of 1,590 men with HGPIN were randomized to receive toremifene (20mg) or placebo followed by yearly biopsy for three years. The modified intent to treat population (MITT) included all men who took one dose of study drug and had at least one on study prostate biopsy. The primary endpoint of the trial was CaP free survival (PCFS) assessed by Kaplan-Meier analysis at three years. This trial analyzed the rate of CaP diagnosis, and variables predicting CaP in the placebo group.

They found no difference in PCFS between the treatment and placebo groups in the trial. The Kaplan-Meier estimated CaP free survival for the placebo group by three years was 30.3%. There were 717 men in the MITT of whom 249 (34.7%) developed CaP. The 34.7% placebo CaP rate observed differed significantly from the hypothesized 25% rate, the CaP rate observed in the placebo groups from previous prevention trials, and the median percentage for published analyses of HGPIN. In the MITT population placebo arm, CaP was diagnosed in 17.9% of subjects in year one, 12.9% of subjects at risk at the beginning of the second year, and 13.6% of subjects at risk at the start of year. Among baseline characteristics evaluated, including serum PSA and number of cores positive for HGPIN, only the presence of ASAP was a predictor of developing CaP (p=0.017: HR 1.410).

 

 

Presented by Samir S. Taneja, et al. at the American Urological Association (AUA) Annual Meeting - May 14 - 19, 2011 - Walter E. Washington Convention Center, Washington, DC USA


Reported for UroToday by Christopher P. Evans, MD, FACS, Professor and Chairman, Department of Urology, University of California, Davis, School of Medicine.


 

The opinions expressed in this article are those of the UroToday.com Contributing Editor and do not necessarily reflect the viewpoints of the American Urological Association.


 

 



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