Big Drop in Prostate Biopsies, Prostatectomies in US

Kristin Jenkins

November 02, 2016

Since the US Preventive Services Task Force (USPSTF) issued its recommendation against prostate-specific antigen (PSA) screening in 2012, the use of PSA screening and digital rectal examinations has decreased significantly, as has the incidence of early-stage prostate cancer.

Now, a study of operative case logs from a nationally representative sample of urologists for the last 7 years shows that the rates of prostate biopsies and radical prostatectomies (RPs) performed have also decreased significantly since 2012 — by 28.7% and 16.2%, respectively.

"These findings represent the direct downstream effects of the USPSTF recommendation," say the study authors, led by Jim C. Hu, MD, MPH, of the Department of Urology at Weill Cornell Medicine, in New York City.

Dr Hu told Medscape Medical News he and his colleagues are "very concerned" about the study findings and that they did not anticipate "the rapidity of the drop in both procedures nor the magnitude of the decrease."

Their report was published online November 2 in JAMA Surgery.

"While the pendulum of prostate cancer screening continues to swing, a more extended vantage point is needed to evaluate the long-term consequences of the 2012 USPSTF recommendation with regard to stage at presentation, outcomes following treatment, and disease-specific mortality in prostate cancer," the study authors suggest.

Four years ago, the USPSTF's recommendation for routine PSA screening for men younger than 75 years was downgraded from a class C to a class D recommendation, effectively taking it off the table. Now that recommendation is being revised, Dr Hu and colleagues note.

Policy makers need to "weigh the downstream effects of the 2012 USPSTF recommendation and consider future unintended consequences," they say.

For the study, the American Board of Urology provided case logs from 5270 urologists applying for certification or recertification from 2009 through 2016. Procedural volumes were validated with biopsy volumes from New York State; RP volumes were valided from the Nationwide Inpatient Sample.

The total number of annual biopsies decreased by 12.7% following the USPSTF recommendation, the study showed, a finding consistent with other, single-institution studies.

The greatest decrease in biopsy volume was seen in biopsies performed when the patient had an abnormal PSA test result (26.7%). At the same time, the number of biopsies performed for cancer surveillance increased by 28.8%, the study revealed.

Declines in biopsy volume were greatest in communities with populations fewer than 100,000.

Male urologists appeared to be responsible for much of the higher biopsy volume; the volume of biopsy was lower for clinicians with a specialty in oncology.

The decrease in RP volume for prostate cancer following the USPSTF recommendation is a unique finding, the researchers point out.

For clinicians who were certified after 2012, RP volume was lower; for male urologists and clinicians with an oncologic subspecialty, RP volume was higher.

Decreases in RP were seen in all practice settings except those in communities with populations of 100,000 to 250,000. Higher RP volumes were seen in communities with a population of more than a million. The lowest RP volumes were seen in New England and the mid-Atlantic region.

Dr Hu and colleagues caution that these trends cannot be solely the effect of the USPSTF recommendation and that it is likely other factors have contributed.

They note that there has been a decrease in the incidence of prostate cancer. In addition, there has been an increase in the use of active surveillance for low-risk prostate cancer and in the use of nonsurgical treatments. Also, biomarkers are improving risk stratification for patients whose PSA screening results are abnormal. Concerns about morbidity related to biopsy may also be playing a role.

Some patients "may miss the window of curability" as a result of the rapid drop in prostate biopsy and radical prostatectomy rates, Dr Hu told Medscape Medical News.

"Additional follow-up and study is needed to determine whether the declines in metastatic disease that followed the adoption of PSA screening in the early 1990s will be reversed with the abandonment of prostate cancer screening," he said.

Dr Hu also expressed concern that results from a 2016 reinvestigation of the US Prostate, Lung, Colorectal, and Ovarian Cancer Screening (PLCO) Trial indicate that one of the two studies upon which the USPSTF based its 2012 recommendation was "extremely flawed."

The investigation showed that in the PLCO trial, men in the control group had undergone more cumulative PSA testing than men in the intervention group.

The Clock Turned Back?

"We may indeed have turned back the clock in the care of patients with prostate cancer," say Pauline Filippou, MD, and Raj S. Pruthi, MD, in an accompanying editorial. They called the contaminated data in the PLCO trial "highly concerning."

It may be too soon to understand the full impact of the 2012 recommendation on prostate cancer epidemiology, note the editorialists, who are both in the Department of Urology at the University of North Carolina at Chapel Hill.

However, subsequent changes in practice patterns have created concern that it "sets back the advancements in prostate cancer detection, treatment, and survival rates made in the last several decades," they say.

The slow-growing and indolent nature of prostate cancer could delay observation of any negative impact of decreased prostate cancer screening "until it's too late," Dr Filippou warned.

"What we don't wish to see is a return to the relatively higher mortality observed for prostate cancer patients that existed before widespread PSA screening," she told Medscape.

Higher-quality trials have shown that PSA screening decreases overall prostate cancer morbidity and mortality, the editorialists note.

From 1991 to 2008, the mortality rate for prostate cancer fell by 39%, a decline for which screening and treatment got the lion's share of the credit. "Today, this fortunate trend may be reversing," they say.

In addition, results from a 2016 study demonstrated a 72% increase in advanced prostate cancer since 2004. Most of the men affected were 55 to 69 years of age and were members of the very group in which screening is most effective.

However, that study created a lot of controversy because, although the authors emphasized that the incidence of metastatic disease had risen, they failed to discuss the incidence rate, which is the epidemiologic standard for measuring disease in populations. A rise in the number of cases of prostate cancer may reflect an increasing number of older men in a population and not a rise in the proportion of men affected.

In an interview, Dr Filippou urged physicians to exercise their clinical judgement when making screening decisions.

"We implore providers to interpret the USPSTF recommendation within the context of their patient's unique history," she said. "It is important not to shy away from screening those at a higher risk of having high-risk prostate cancer, particularly African American men over 45 and men with a family history of prostate cancer."

Prostate cancer detection does not always mean surgical treatment, she noted. Just having an informed conversation about prostate cancer screening "could have enormous benefits for patients."

When asked to comment, Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic, Ohio, said he is also concerned about the impact of the 2012 recommendation and points to recent evidence suggesting "it is not safe to find fewer low-grade cancers."

The negative effect on screening of the USPSTF recommendation "is going to lead to underdiagnosis of potentially lethal cancers," he predicted.

When the USPSTF relied on data that compared "screening to screening" and decided the PSA test had no value, "what they should have said was that the then current screening regimen of screening every man starting at age 50 once a year until they die of something else does not save lives," said Dr Klein.

His message to clinicians? "The PSA test still has value."

And in fact, the European Randomized Study of Screening for Prostate Cancer, which was also considered by the USPSTF before it made its recommendation, showed a 21% reduction in prostate cancer mortality in men aged 55 to 69 years.

More recently, the ProtectT trial showed there is a risk for metastatic disease even in carefully selected patients who appear to be at low risk, noted Dr Klein.

At 10 years, the rate of metastatic disease was about 10%, and there was an equal number of deaths in patients with the lowest-grade cancers (Gleason score 6) and intermediate-grade cancers (Gleason 7).

The possibility that even histologically low-grade tumors have lethal potential has been borne out by data from molecular studies, which show that 5% to 10% of Gleason 6 tumors have molecular features characteristic of high-grade cancers, he said

"We now have at hand the ability to distinguish those low-grade cancers that have real biologic potential for harm and can make more informed decisions about who is safe for active surveillance and who needs treatment," Dr Klein said.

He suggested that it is time to define a new way of screening and that the available data make that possible. He noted that baseline PSA screening at age 50 can predict lifetime risk for prostate cancer.

Men with a PSA lower than the population average at age 50 "probably only need to be screened once every 5 years," he said. Men with a PSA level higher than the population average at age 50 have a 10% or more increased lifetime risk for prostate cancer and should be screened more frequently, probably every other year.

An abnormal PSA level at age 60 is associated with a very low risk (1%-2%) of developing metastatic or lethal disease, and men in this group would be well served by less intense screening or none at all, Dr Klein said.

Last but not least, new blood tests are much more accurate than the PSA test for detecting aggressive prostate cancer and should be used either as an adjunct to the PSA test or as a replacement. These include the Prostate Health Index (phi), the 4kscore test (OPKO), and other tests involving urinary biomarkers.

Patients should be included in decision making, and family physicians need to take the time to educate them about the pros and cons of screening and various approaches to treatment or follow-up, he added.

"We rely on primary care physicians for patient education and patient selection," noted Dr Filippou. And although she admits that the sensitivity and specificity of the PSA test may not be perfect, it is still "one of the only easy, inexpensive, and widely accessible prostate cancer screening tests we have."

There should be no hard-and-fast cutoff age for screening, she emphasized. A healthy 70-year-old man with few comorbid conditions may benefit from early prostate cancer detection, whereas the man with disease that would limit his lifespan significantly "may not be the best candidate for PSA screening."

For now, PSA testing remains a hot topic for many clinicians and their patients.

"The decision for men to get PSA testing is a personal one, as [the American actor] Ben Stiller recently came out and mentioned," Dr Hu said. "Surprisingly, he was criticized for this. I believe that this shows how polarizing and controversial this topic is."

No funding for the study was reported. Dr Hu has a relationship with Intuitive Surgical and Genomic Health. Coauthor Art Sedrakyan, MD, PhD, has a relationship with the US Food and Drug Administration. Dr Klein has relationships with GenomeDx, Genomic Health and Berg Health.

JAMA Surg. Published online November 2, 2016. Full text, Editorial

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