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Elai Davicioni, president of Genome DX, and research scientist Jenne Hansentake perform genomic analysis on an RNA sample at the company's facility in San Diego, March 26, 2013. Sophisticated new prostate cancer tests are coming to market that might supplement the unreliable Prostate-Specific Antigen test, potentially saving tens of thousands of men each year from unnecessary biopsies, operations and radiation treatments. (Sandy Huffaker/The New York Times)

SANDY HUFFAKER, NYT - NYT

New prostate tests aim to give better cancer treatment options

  • Article by: ANDREW POLLACK
  • New York Times
  • March 27, 2013 - 5:12 PM

Sophisticated new prostate cancer tests are coming to market that might supplement the unreliable PSA test, potentially saving thousands of men each year from unnecessary biopsies, operations and radiation treatments.

Some of the tests are aimed at reducing the false alarms and accompanying anxiety caused by elevated PSA readings. Others, intended for use after a definitive diagnosis, probe the genetic workings of the cancer to distinguish dangerous tumors that need treatment from slow-growing ones that might be left alone.

The tests could provide a way out of the bitter debate over whether healthy men should be screened for prostate cancer.

The problem with the PSA blood test is that many of the cancers it detects are unlikely to cause harm. But there is no reliable way to identify them. So a large majority of men with positive tests undergo surgery or radiation treatment, and many suffer for years, needlessly, from such complications as incontinence and erectile dysfunction.

In late 2011, the U.S. Preventive Services Task Force, a government advisory body, provoked a furor by recommending against screening, saying that far more men were harmed by unnecessary biopsies and treatments than were saved from dying of cancer.

But if new tests can better determine risk, screening could become more useful.

“It’s not that screening doesn’t work; it’s that we haven’t done a great job of targeting treatments for the tumors that need it,” said Dr. Matthew Cooperberg, an assistant professor of urology at the University of California, San Francisco and a consultant to some testing companies.

More than a dozen planned

Reducing unnecessary treatments could also reduce the $12 billion in estimated annual spending related to prostate cancer. Test developers hope that such savings will make their tests cost-effective, even at prices that will exceed $3,000 in some cases.

More than a dozen companies have introduced tests recently or are planning to. Rather than looking at a single protein like PSA, which stands for prostate-specific antigen, many of these tests use advanced techniques to measure multiple genes or other so-called molecular markers.

Experts caution that it is too early to tell how well most of the tests will perform and whether they will make a difference. Although the tests are intended to help men make treatment decisions, they also could cause more confusion.

“It’s a little tricky to find out which one applies to you and whether it will be paid for by insurance,” said Jan Manarite, who runs a phone help line for the Prostate Cancer Research Institute.

Prostate cancer specialists say that screening has declined since the task force recommendation, but millions of U.S. men still get regular blood tests to measure PSA. As many as 1 million undergo biopsies each year, with about 240,000 prostate cancer cases diagnosed and 28,000 deaths from the disease.

How aggressive the cancer?

The biggest battle among test developers could be between Genomic Health and Myriad Genetics, known for successes in breast cancer testing.

The companies say their tests, which analyze gene activity levels in the tumor sample obtained by biopsy to gauge how aggressive the cancer is, provide better information than the Gleason score, the main tool now to assess tumor aggressiveness, based on how cells look under a microscope.

“We already know from conventional information that there are a group of men who are very unlikely to have progression, but they still get treated,” said Dr. Lee Newcomer, senior vice president for oncology at UnitedHealthcare.

Some experts say that even if the new tests are not perfect, they are better than what is available now.

“Even if we can only convince 15 to 20 percent of men that we have enough confidence that they don’t need to be treated, that will be a big step forward,” said Dr. Eric Klein of the Cleveland Clinic, who has worked with Genomic Health.

Some experts say unnecessary procedures can be reduced simply by using the PSA test less frequently and with improved imaging.

The new tests are “singles and doubles at best,” said Dr. William Catalona, director of the prostate program at Northwestern University, who helped bring the PSA test to market in the 1990s.

But, Catalona said, this is only the start.

“This field is moving kind of like cellphones,” he said.

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