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Shrinkage of prostate led to overestimation of cancer risk in trial
Date:9/12/2007

s among men in the finasteride group who were already harboring high-grade tumors at the start of the study.

"This is a very unusual situation -- though it will become more common in the future -- where the drug affects the marker we use to find the cancer," said Gann.

Using data from the Prostate Cancer Prevention Trial study, Gann and colleagues developed statistical models that took into account the size of the prostate gland and the number of needle cores that were taken during biopsy. In essence, the researchers compared finasteride to placebo among men with an equivalent number of needle samples per unit of gland volume.

The analyses showed that adjusting for changes in gland size due to the drug could account for all of the excess high-grade tumors.

"Once we did this adjustment, all the excess high-grade went away, and the effect of the drug on low-grade cancer was even stronger, as we would expect," Gann said.

"This drug may have been much better than people thought," Gann said, "and the fears about its impact on high grade tumors may have been exaggerated based on this bias alone."

However, he said, the findings must be interpreted cautiously, and the new results alone do not justify definitive changes in clinical practice or widespread use of the drug.

"Our goal is to improve scientific understanding of what happened in this very important and expensive trial."


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Contact: Sherri McGinnis Gonzlez
smcginn@uic.edu
312-996-8277
University of Illinois at Chicago
Source:Eurekalert

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