A Pivotal Study for FDA Approval

Categories: Fall 2008
Some members of Dr. Catalona’s research group
Some members of Dr. Catalona’s research group in Chicago: (l to r) Chris Griffin; Kelly Maxell, MD; Kris Lathan, Davis Viprikasit, MD; William J. Catalona, MD; Donghui Kan and (sitting) Sara Gashti and Dana Mondo

Last year, thousands of men got free screenings for prostate cancer at mobile medical vans.

But, this screening was more than the standard PSA test. It was a study of an experimental diagnostic tool, pro PSA, that’s supposed to be better than existing tests for detecting prostate cancer.

Now, researchers have the results.

Under the direction of Dr. Catalona, Northwestern is one of four sites participating in a pivotal study to test whether the Pro PSA test is safe and effective at improving the accuracy of PSA testing.

These sites are working with Beckman Coulter Incorporated to gather the information necessary for FDA approval of Pro PSA testing.

“The Pro PSA test is about twice as accurate as the standard test. That seems to be especially true for finding aggressive prostate cancer in its earliest stage,” Dr. Catalona said.

The Pro PSA seems to be a better marker than free or complexed PSA for distinguishing between PSA elevations due to prostate cancer and those due to benign conditions of the prostate.

The issue is not just about saving lives, but about preventing

unnecessary and uncomfortable prostate biopsies.

“The name of the game in prostate cancer detection is to detect the cancer early because it’s 100 percent curable if you detect it before it has spread beyond the prostate,” Dr. Catalona said.

Until a larger study confirms the promise of Pro PSA testing, it won’t

be widely available. That could happen within a year.

Dr. Catalona and his research group are enrolling men in a research project to evaluate the new Pro PSA screening test for prostate cancer.

Men 40 years and older are eligible to participate.

If interested, men can enroll in the study or find out more informationby calling Chris Griffin, Clinical Research Project Coordinator for Dr. Catalona: 312-695-4426.

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