Easy, Safe, and Informative
For physicians considering including a new test into their prognostic and diagnostic regimens, the two biggest factors are that the test be safe to administer and provide clear, actionable results — in other words, that it return information that can directly inform decisions about treatment plans.
According to Dr. Neal D. Shore, Medical Director of the Carolina Urologic Research Center, genomic testing for cell cycle progression (CCP) in prostate cancer fits both of these requirements.
“This is a really great test,” says Dr. Shore, “because you can just take the existing biopsy tissue sitting on the slide in the pathologists lab and, with no rebiopsy, you send it to the lab and the urologist gets a report back in ten to fourteen days with a score showing the level of risk.” That the test can be administered without requiring an additional procedure for the patient is a massive benefit, making it easy to slot into existing practice. The question then becomes one of whether the results returned can meaningfully inform treatment.
“We’ve just completed a 1,200-patient clinical utility study which shows that the information is actionable,” says Dr. Shore. The study, published earlier this year in the Journal of Urology, found that the CCP test caused a change in actual treatment in 48 percent of patients, with 72 percent of those changes being in favour of treatment reduction. This is a big win in both directions, confirming the wisdom of active monitoring for low-risk patients, while ensuring appropriate treatment for those who might have been erroneously diagnosed as low-risk without the test.