About a dozen new medical tests are coming to market that aim to more accurately diagnose prostate cancer and go well beyond the standard PSA blood screenings used today. Several of them may even allow men to forego getting a biopsy that more than 1 million men diagnosed with prostate cancer undergo each year. For men entering the latter half of their lives, a diagnosis of prostate cancer can be frightening.
About 30 million men are screened for prostate cancer each year, according to the Centers for Disease Control and Prevention. Of that number, more than 180,000 will be diagnosed annually, and a smaller subset – 26,000 – will die of the disease, said the Prostate Cancer Foundation. While the name evokes consternation for good reason, deciding whether to treat or not treat prostate cancer can be maddening.
Sometimes the risk of undergoing surgery to remove a prostate, or radiation to fight the cancer, can be greater than the risk of actually dying from prostate cancer itself – especially if it’s not an aggressive form of prostate cancer. Men with low-risk cancers will undergo surgery or radiation, according to medical experts.
“Prostate cancer is totally different and unique from any other cancer out there,” said urologist Jeremy Lieb, who practices at Pacific Urology in Walnut Creek, California, and has 14 years of experience.
By testing samples of blood and urine or analyzing the genetic makeup of prostate cells for changes in their DNA, urologists are trying to more accurately determine not only if men have prostate cancer but also if those diagnosed have aggressive cancer that calls for further treatment or indolent, low-grade prostate cancer that poses very little risk. Almost 100 percent of prostate cancer cases are curable, and among the biopsies performed annually, only about one-quarter show cancer in the prostate.
For men with prostate cancer who undergo radiation or surgery to remove the prostate gland, the side effects can be onerous and include incontinence and infection. In the United States 1 in 7 men will be diagnosed with prostate cancer in his lifetime. As men increase in age, their risk for developing prostate cancer increases exponentially. Prostate cancer is 100 percent treatable if detected early. The challenge is in separating the patients with aggressive cancers that need immediate treatment from the patients with lower-risk cancers that can be monitored at annual check-ups.
“All of these tests are focused on helping us pick out who has indolent cancer that we can keep an eye on and who has aggressive cancer and can risk the side effects from treatment and surgery,” said Phillip M. Pierorazio, urologist and faculty member at the James Buchanan Brady Urological Institute at Johns Hopkins Hospital.
The new tests – using blood, urine and tissue samples – go well beyond PSA tests and aim to tell men in advance, not just if they have prostate cancer but if it is aggressive enough to warrant treatment or if it can be safely monitored instead. While most have been validated in retrospective laboratory studies, only a few have been vetted by the Food and Drug Administration.
“We caution patients and doctors that no independent body has reviewed such tests to determine whether they are safe and effective,” said one FDA spokeswoman in an email to CNBC. A new urine test from Cambridge, Massachusetts-based Exosome Diagnostics looks at exosomes – messengers between cells that can help cancer travel.
“The problem is, when a patient hears cancer, they want to be treated,” said Tom McLain, COO of Exosome Diagnostics.