Diseases & Conditions

Einstein Expert Offers Insights on New Prostate Cancer Testing Proposal

By on 04/25/2017

A federal medical panel has proposed a change in its stance on screening for prostate cancer. Previously, the U.S. Preventive Services Task Force advised that men not be tested routinely for prostate cancer. The panel’s position has changed in a significant way, opening the door for testing men of a particular age range. We spoke with Serge Ginzburg, MD, FACS, director of Einstein’s Prostate Cancer Center, to better understand what this proposed change means.

Serge Ginzburg, MD, FACS

Serge Ginzburg, MD, FACS

How is the task force’s position changing?

No official change in recommendation has been issued yet, but a preliminary draft has been posted online for public commentary, suggesting that a change is coming. The proposal calls for the PSA screening recommendation to be changed from “do not screen anyone” to “may screen men between the ages 55 and 69 after having individualized discussion regarding risks and benefits and incorporating patient’s individual values.”

To understand this change, it is critical to recognize the historic context of the recommendations. PSA is a blood test that measures a protein produced exclusively by the prostate—Prostate Specific Antigen (PSA).

PSA may be abnormally elevated for many reasons, one of which may be prostate cancer. This test was widely adopted in the early 1990s and became a means of screening for prostate cancer. Historically, once elevated PSA is discovered, prostate biopsy follows, half the time resulting in a diagnosis of prostate cancer.

While imperfect, the PSA test can pick up cancers approximately seven years earlier than they would present otherwise. Once use of PSA test became widely accepted, there was an increase in prostate cancer diagnosis, along with a corresponding decrease in prostate cancer metastases (spreading beyond the prostate) and prostate cancer-related deaths.

Unfortunately, along with aggressive, clinically significant prostate cancers, many newly diagnosed cancers were low-grade, slow-growing, and clinically insignificant. Catching such cancers early is usually not beneficial.

Early treatment of prostate cancer, before tumor biology was fully understood and accepted, was a “one size fits all” approach, where patients, once diagnosed, would be treated with prostate removal (radical prostatectomy) or radiation.

The modern approach to treatment focuses on matching treatment type to tumor aggressiveness, and sometimes choosing to avoid or delay treatment is critical. While treatment of clinically significant prostate cancers results in a decrease in the odds the cancer will spread and a reduction in prostate cancer-specific deaths, treatment of low-risk prostate cancer does not demonstrate the same benefits, while resulting in burdensome side effects.

As the differences between prostate cancers were beginning to be recognized, options such as active surveillance emerged. Active surveillance allows us to more appropriately treat less aggressive prostate cancers and as such, may avoid treatment for a significant portion of newly diagnosed patients. Adoption of active surveillance is still in progress, but we’re making great strides, with close to 45 percent of low-risk prostate cancer patients nationwide enrolling in active surveillance and avoiding immediate treatment.

With respect to the federal task force’s recommendations, the utility of the PSA test was assessed in 2012. Two large randomized clinical trials and data on contemporary practice patterns, side effects and complications of interventions were used for the basis of the initial recommendation.

The two randomized trials, one from Europe (ERSPC), and the other from the U.S. (PLCO), did not agree in their conclusions. The ERSPC trial demonstrated a benefit to PSA screening, while the PLCO trial did not. After combining all available information, the task force recommended against routine PSA screening for men of any age group. This was contradictory to many specialty professional societies, including the American Urologic Association (AUA) and National Comprehensive Cancer Network (NCCN). Of note, no urologists participated on the task force panel in deciding on the appropriateness of this urologic cancer screening test.

Why has the task force’s position changed? Does the proposal reflect new research findings? If so, what do the findings suggest?

Since the last federal task force recommendation in 2012, new information about the U.S. clinical trial has emerged, longer follow-up of European trial became available, and a new randomized trial from the U.K. was considered.

Specifically, the U.S.-based clinical trial showed significant contamination in the control group—that is, almost 90 percent of the control group patients who were thought to not have undergone PSA testing were discovered to have had at least one PSA test, undermining study conclusions. Additionally, practice patterns have changed dramatically. With the risk-stratified treatment approach widely applied, many clinically insignificant prostate cancers are now monitored on active surveillance protocols instead of being subjected to radical treatment.

On April 11, 2017, a new recommendation was proposed, from recommending against screening because potential benefits do not outweigh the harms, to recommending that the decision should be made based on detailed discussion about harms and benefits and should include patient’s individual values and preferences—shared decision making. Appropriate screening age of 55 to 69 was identified, which happens to be in keeping with the American Urologic Association recommendations.

The new proposed recommendation seems to place more power in the hands of men 55 to 69. (Routine screening is still not recommended for men over 70.) They can talk to their doctor and decide for themselves whether the risks of screening outweigh the benefits. We’ve talked about the potential benefits described in the research findings. What are the risks?

Benefits include decrease in risk of the prostate cancer spreading and a decrease in risk of dying from prostate cancer. Harms include over-diagnosis—identifying cancers that are not clinically significant and would not cause harm during patient’s lifetime, and over-treatment—treatment that is not proportional to the aggressiveness of the disease.

False positive PSA tests may lead to unnecessary biopsies, which may be associated with pelvic pain and temporary bleeding in stool, urine and semen. A small percentage of patients may develop an infection and approximately 1 percent will require a hospitalization after a prostate biopsy.

It is also important to recognize anxiety and stress that may result from being diagnosed with a cancer.

Treatment side effects may include erectile dysfunction and usually temporary urinary incontinence. Depending on the treatment method, fecal urgency and proctitis (inflammation of the lining of the rectum) may develop. While we have effective ways to at least partially manage many of these side effects, they should be recognized and disclosed at the time of screening.

Several organizations, such as the American Urological Association, agree with the new recommendation. Other organizations, including the American Academy of Family Physicians, disagree. Is the federal panel’s position likely to be controversial? If so, why?

Anytime a recommendation that deviates from the established norm is released, there’s going to be controversy. This is one such scenario. While the urologists didn’t really accept the 2012 recommendation to not screen, it was rapidly adopted by the primary care community and screening patterns shifted quickly toward not screening. It will take some time to reverse this trend and get other professional societies on board.

Additionally, the gold standard is a randomized controlled trial that demonstrates improvement in overall survival. While this is not available, evidence for a decrease in metastasis and cancer-specific deaths exists and largely accounts for the federal task force’s change of course.

What is your take on the federal panel’s proposed recommendation?

I strongly support PSA screening and concur with AUA guidelines. Additionally, there is provocative data to support early screening, by getting a baseline PSA at age 40 and then establishing frequency of future tests based on that baseline value. Some men may benefit from annual screening, whereas others may only need to be screened every two to four years.

Additionally, men of African-American heritage are more than 60 percent more likely to develop prostate cancer, have earlier onset of disease and are 2.3 times more likely to die of prostate cancer than Caucasian men. Similarly, men with a family history of prostate cancer in a first-degree relative are at a significantly higher risk of harboring a malignancy. The task force recommendations, however, fall short of addressing these vulnerable populations and it is up to physicians to look to other guidelines and professional societies to take the initiative and to engage these patients to participate in smart, targeted screening.

Importantly, the task force does not provide guidance on the actual value of PSA that is considered abnormal. Historically, it was greater than 4, although in many trials it was 2.5 or 3. Internally, in our practice we use a value of 2.5 but equally important is recognition of a rising trend, even if the actual abnormal value is not exceeded.

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