Dr. Vipul Patel

Orlando physician Vipul Patel, MD, one of the world’s leading prostate cancer surgeons, shook his head in disappointment when the U.S. Preventive Services Task Force (USPSTF) recommended that doctors stop using the PSA (prostate specific antigen) test as a means to screen men for prostate cancer, regardless of age, risk factors and ethnicity.

The government advisory panel – comprised of primary care physicians (PCPs) and researchers, but no urologist, medical oncologist or radiation oncologist – reached the conclusion based on flawed data and as a result, jeopardized the health of men around the globe, said Patel, pointing out that prostate cancer represents the most commonly diagnosed solid organ tumor in men and is the second leading cause of death. Approximately 240,000 men are diagnosed annually with prostate cancer; some 40,000 men die from it.

In a move to sway panel members to reverse their decision, Patel established the International Prostate Cancer Foundation and initiated an online petition that garnered 4,225 signatures in its first month. “We’ve done very well; the petition needs to grow,” said Patel, who’s also spoken with lawmakers who support overturning the panel’s recommendation.

Patrick Daily, MD, a partner with Mississippi Urology Clinic PLLC, that state’s oldest and largest specialty practice of its kind, pointed out the goal of prostate cancer testing isn’t only to prevent mortality, “but even more so to prevent attendant morbidity that comes with metastatic prostate cancer, such as urinary obstruction, fractures, and significant bone pain. When used appropriately, the PSA test provides clinicians with valuable information to aid in the diagnosis of prostate cancer.”

The PSA test has been the standard protocol for routine screening and the detection of prostate cancer since the early 1990s. The simple blood-based test ordered for men over the age of 40 as part of routine blood work on an annual basis has led to a 40 percent reduction in mortality from prostate cancer.

“Since PSA screening became part of the healthcare profile of men, the death rate from prostate cancer has reduced consistently every year,” said Daily. “The removal of it will increase the diagnosis of advanced disease and the mortality rate from prostate cancer.”

Before the PSA era, prostate cancers were most commonly found following the onset of symptoms from late-stage disease. Symptomatic tumors were of a higher grade, more advanced and often deadly.

“During the PSA era, SEER data demonstrates a 75 percent reduction in proportion of patients who present with metastasized prostate cancer,” said Daily. “The American Urological Association (AUA), which is outraged at the USPSTF's failure to amend its recommendations on prostate cancer testing to more adequately reflect the benefits of the prostate-specific antigen (PSA) test in the diagnosis of prostate cancer, strongly supports informing men of the risks and benefits of prostate cancer screening before biopsy, and the option of active surveillance in lieu of immediate treatment in certain men newly diagnosed with prostate cancer.”

The panel reached their decision primarily based on short-term studies, particularly a U.S. study of 40,000 screened versus non-screened men who were followed for seven years. “Prostate cancer is slow-growing, so that wasn’t an accurate reflection,” explained Daily, noting that a 12-year study in Europe involving 180,000 men that showed a 30 percent difference in the death rate from prostate cancer in screened versus non-screened men wasn’t considered by the panel.

“It’s inappropriate and irresponsible to issue a blanket statement against PSA testing, particularly for at-risk populations, such as African-American men,” he said. “Men who are in good health and have more than a 10 to 15 year life expectancy should have the choice to be tested and not discouraged from doing so.”

Daily and Patel admit the PSA screening guidelines could use some tweaking, while researchers seek a better marker for prostate cancer diagnosis.

“Rather than waiting for a better test to come out, the task force flatly said: no testing,” he said. “Lumping everyone together was a major mistake in healthcare. What about African-American males, who have a 200 percent chance of dying from prostate cancer? What about the 45-year-old with prostate cancer?”
Daily added: “Eventually, we’ll have genetic testing to show cancer markers. Until then, if the task force doesn’t reverse its recommendation, it’ll be up to primary care physicians to make sure their male patients are educated on PSA testing. When it’s part of routine screening, men will get it regularly. When it’s not, men may not know to ask for it specifically, or they may be reluctant to. That’s why education from referring physicians is so very important.”

Other PSA screening solutions are in the works. Beckman Coulter Inc., makers of prostate cancer diagnostics, recently achieved FDA Premarket Approval (PMA) for the Prostate Health Index (phi), a simple, non-invasive blood test that’s 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4-10 ng/mL range and is proven to reduce the number of prostate biopsies. The company developed the new test as an answer to the current PSA testing controversy, where prostate cancer screening to save lives has been weighed against over-diagnosis and over-treatment.

“Prostate Health Index … provides more accurate information physicians and patients need for better decision-making,” said William Catalona, MD, director of the Clinical Prostate Cancer Program at Northwestern University in Chicago and founder of the Urological Research Foundation. “Now, patients and physicians wondering what to do with an elevated PSA test result in the 4-10 ng/mL range have a new, non-invasive option. This represents an advance in the science of prostate cancer management.”
Patel pointed out that only a few years ago the same organization, the U.S. Preventive Services Task Force, concluded that mammograms were unnecessary in screening women for breast cancer, but later rescinded their conclusions after a backlash from the medical community. Patel is striving for the same result concerning PSA screening.

“Ladies did very well, took their cause to the streets, were very aggressive and got the recommendation overturned so that mammograms are still allowed for breast cancer screening,” he said. “Men to this point haven’t been so vocal. We need to step up as a nation and take back our rights as men, the right to make choices on our own healthcare.”

Patel called the panel’s recommendation “a step toward rationing healthcare, like they do in other parts of the world.”

“The reason for the task force is economically driven,” he said. “PSA testing isn’t expensive. It’s only about $20 per patient. Eliminating PSA testing will save hundreds of millions of dollars for the federal government – on the surface. The cost to society will be much higher in the long run. Prostate cancer will become the most common cause of death unless men stand up for their rights to be allowed to make the decision on their own healthcare.”