Tag Archive for: PSA testing

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The USPSTF Changes Course: a “C” rating for PSA screening in ages 55-69. I did not see this coming.

It should surprise no one that I never agreed with the 2012 United States Preventive Services Task Force to give PSA a “D” rating that has led to decreases in U.S. rates of PSA testing, biopsies, and diagnosis of low- through high-risk cancer. I take care of men with prostate cancer in a multidisciplinary clinic at a dedicated cancer hospital. I perform robotic surgeries and manage over a 1,000 men on active surveillance. If you search the BJUI blogs, you can find the often viewed (>80K) “Melbourne Consensus Statement on Prostate Cancer Testing” that included 15 authors who produced 5 consensus statements on the topic. There are 62 comments—comment #5 is a fairly famous one that equates the panel to “a group of 10 pig-farmers telling us we should eat more bacon.” So yes, I think I count as a pig farmer here. My maternal grandfather and great uncle farmed pigs in Western Tennessee, so it does run in the family.


USPSTF PSA screening: Pig farming or roboticsFigure 1: It was either this or robotics

That said, it always seemed odd, that as a large country and major healthcare market, we rolled out PSA screening in the 1990s with wild enthusiasm and without data on benefit, only to then try and roll it back in when faced with two conflicting level 1 evidence studies. Meanwhile, the American Urological Association guidelines recommended PSA screening (with the “shared decision making caveat”)—mostly mirroring the European study—for men ages 55-69 (also consensus statement 1 from the Melbourne consensus). However, a recent fact struck me during a conference talk—Urologists in the U.S. are estimated to order <10% of all PSA tests, and a vast majority are from primary care physicians. So in essence it doesn’t matter as much what we think of one guideline versus another, it’s what the primary care specialties think that matters. As the USPSTF is targeted at primary care, their D rating did have an effect—fewer PSA tests, biopsies, and diagnosis of all grades of cancer (not just Gleason 6). We have heard stories over the years that specialty exams in primary care were starting to feature PSA screening questions, and the “don’t screen” answer was the one you got credit for. But I was also never convinced that most primary care physicians were comfortable with abandoning screening either. They must have seen what we saw—real cancers presenting later stage.

Some memorable quotes along these years of debate:

“There is no evidence prostate carcinogenesis has declined.” Joel Nelson, J Urol 2015

“I believe the USPSTF recommendations have created confusion at the patient and primary physician level, and that this confusion did not likely result in more informed, shared decision making, but instead avoidance of the issue.” Samir Taneja, J Urol.

Amen. So now it’s 2017 and the USPSTF has looked at the data again. They’ve had their “analysis” methods on the web for a while so we know something was planned. I can’t find authorship credits anywhere—we always complained that no prostate cancer experts were involved in the past, and now wondering who is driving this ship. The take home messages are:

  1. Offer PSA screening to ages 55-69 with shared decision making. The narrative is not “do screening.” It’s a full paragraph with the often told caveats of individualized decisions, potential harms and benefits. It’s limited to the reduction in mortality way of thinking, i.e. no thought to preventing metastatic progression, palliative care, etc.
  2. Don’t screen in men ages 70 and older. From an evidence standpoint—hard to argue and the AUA guidelines are similar. The Melbourne Consensus is at least polite enough to point out that not all men over age 70 are going to drop dead any minute, and maybe some of them should be screened if very healthy (level of evidence = CS for common sense).
  3. We recognized that men with a family history of prostate cancer or African American race are higher risk, but we don’t have evidence to support a different screening policy. Again—hard to argue with the evidence and the AUA says the same.

So really that’s it—3 main concepts. This is likely to be a significant impact in the U.S., depending upon whether or not primary care physicians change practice (and their exam questions are the same with a different correct answer).

Probably what is on your mind now is “why the change.” It does not appear to be one thing—not even recent publications revealing a more significant pattern of PSA contamination in the PLCO trial. The checklist seems to include: 1) PCLO “issues”, 2) more data from ERSPC and its subsets, 3) more data on treatment benefit, and 4) increased use of active surveillance in low-risk disease. So the balance tipped in favor of a “C” although they state the benefits and harms are still close. Fair enough.

As I re-read the 2013 Melbourne Consensus and compare to the 2017 USPSTF statement, there is a lot of overlap now. So congrats to the Melbourne group for getting it right in the first place. I, myself, did not see this coming—just another example of why I don’t invest in individual stocks or otherwise pretend to know the future.

I apologize as I re-read this, as I realize we Americans think the world revolves around us. Many of you certainly live in countries that are against routine screening and manage to get by. By all means, please sound off on what you think this means for the international picture of men’s health.

USPSTF PSA screening: Scenic Melbourne at duskFigure 2: Scenic Melbourne at dusk

 

John W. Davis is BJUI Associate Editor for oncology. @jdhdavis

 

 

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Abandoning PSA screening: What is an acceptable price to pay?

MoonThe PSA screening debate continues to rage with conflicting advice from various bodies as to appropriate guidelines for men considering prostate cancer screening. In Australia the Urological Society of Australia and New Zealand (USANZ) has supported offering screening to men aged 55-69 [Urological Society of Australia and New Zealand Position Statement on PSA testing 2009], as has the Royal Australasian College of Pathologists [Royal College of Pathologists Australia Position Statement on PSA testing 2014], however the guidelines for General Practitioners is yet to endorse this approach.   A consensus group gathered by the Cancer Council of Australia, including Urologists, Oncologists, Epidemiologists and consumer advocates have recently put together proposals being considered by the NHMRC that recommend screening in men of an appropriate age with >7 year life expectancy, as long as active surveillance is offered to those diagnosed with low risk disease [Cancer Council Australia: Draft Clinical Practice Guideline PSA Testing and Early Management of Test-Detected Prostate Cancer]. The US Preventative Service Task Force Grade D recommendation against screening has been well documented, yet widely criticized for failing to include Urologists in its deliberations – the very specialists tasked with evaluating and treating localized prostate cancer.

Screening trials have reported conflicting results [Schroder et al, Pinsky et al], however with longer follow-up it becomes easier to demonstrate a survival advantage in men who are screened, and this does not even directly take into account the reduction in morbidity from advanced disease in populations as a result of early detection.

The issue at hand seems inherently very simple – that mass PSA screening will inevitably lead to overdiagnosis and, if a conservative approach is not adopted in low-risk disease or men with significant co-morbidities, overtreatment. Since PSA testing was introduced, the natural history of prostate cancer has become better understood [Albertsen], along with the understanding that many men with prostate cancer harbor “clinically insignificant” disease. Urologists have recognized this internationally and developed active surveillance protocols in response [Kates et al, Klotz]. Here in Australia the Victorian prostate cancer registry now confirms a significant number of men with low-risk disease being managed conservatively [Evans].

In the meantime, however, the pendulum is swinging the other way, and on the back of the USPSTF recommendations we are now seeing evidence of a drop in PSA screening.   Confusing the debate is the extrapolation of negative studies to men of an entirely different population (e.g. using the Prostate Cancer Intervention vs Observation Trial [PIVOT], which comprised an average age of 67 to conclude that men in their 50s will not benefit from screening), poor design of the reported screening trials (e.g. the PLCO trial, which formed the backbone of USPSTF recommendations but due to compliance/contamination compared a population of 52% screened vs 85% screened), and the accusations of vested interests, particularly when Urologists take a pro-screening position (just read comment section on BJUI 2013 report of “Melbourne consensus statement on prostate cancer testing”)

What is the end result at a population level? In Victoria, Cancer Council data confirm a drop in prostate cancer screening and diagnosis [FIGURE]. There is no reason to believe that true prostate cancer incidence has suddenly declined, and we can conclude therefore that the negative publicity surrounding PSA screening is having an impact and less men are undertaking screening and diagnosis; a reversal of the jump in incidence that occurred when PSA testing was first introduced.   Is this a bad thing though? Could this just be that we are finally reducing the diagnosis of clinically irrelevant cancers that are the bane of a PSA screening programme?

 

MoonFig1
Trends in prostate cancer incidence and PSA testing rates, 2001-2014

Source: Cancer in Victoria: Statistics and Trends 2014. Cancer Council Victoria

 

My disclosure is that as a Urologist with a subspecialty practice in prostate cancer management, I deal at a personal level with patients, rather than population statistics, and in the last few months alone, multiple patients have highlighted for me the sacrifice we must admit to making if we are to abandon or even discourage PSA testing. A few specific cases are worth sharing as scenarios that GPs could consider including in the risk/benefit discussion required before ordering a PSA test.

Case 1:
64-year-old, well man with no relevant past/family history was referred with a rising PSA from 3.9μg/L in 2010 to 6.6μg/L in 2011. No abnormality was found on rectal examination and a biopsy was advised but refused given contemporary publicity in the lay press outlining the risk of biopsy and harms of overdiagnosis/overtreatment. Over the next 5 years the patient undertook various natural remedies and in 2014 when the PSA was 13.3μg/L, an MRI was performed that demonstrated a PIRADS 4 lesion. It was only until 2015 when the PSA had reached 21.9μg/L that a biopsy demonstrated a significant volume of Gleason 9 adenocarcinoma, with pelvic lymphadenopathy on staging.

Case 2:
A 57-year-old man requested PSA screening in 2013; however, he was advised by his local doctor that this was unnecessary based on current guidelines. In 2015 the patient’s brother was diagnosed elsewhere with prostate cancer and underwent radical prostatectomy. The patient then demanded a PSA, which was performed and found to be 40μg/L. Rectal examination revealed a firm, clinical stage T3 malignancy and biopsy demonstrated extensive Gleason 4+4 prostate cancer.

Case 3:
A 51-year-old man was found in 2010 to have a mildly elevated screening PSA of 4.5μg/L. Despite repeated recalls from the GP to have this repeated and further investigated the patient refused until in 2015 he presented with obstructive voiding symptoms and was found on examination to have a diffusely firm, clinical stage T3 malignant prostate. Repeat PSA was 39μg/L and subsequent investigation confirmed extensive Gleason 9 prostate cancer with positive pelvic lymph nodes.

For these men curative treatment is probably no longer an option. Whilst a small anecdotal group, these are real men seen at a community level who demonstrate the power of PSA screening to identify aggressive, clinically significant disease, at an early, curable stage. This is the coalface that General Practitioners and Urologists work at. When the USPSTF ratifies the Grade D recommendations on the basis of flawed and often misinterpreted trials in the absence of specialists who treat such patients, when Epidemiologists and well-meaning Oncologists who never see or evaluate localized prostate cancer lobby against the harms of overdiagnosis and overtreatment, they are condemning these men, and many others, to suffer and die from a preventable disease.

This risk of increased advanced cancer in a non-screened population has already been foreseen and reported [Scosyrev]. How many such men is it acceptable to sacrifice in the name of preventing overdiagnosis and overtreatment?

Rather than the knee-jerk response to abandon PSA testing, the answer, which is increasingly accepted by Urologists, is clearly to unlink prostate cancer diagnosis from treatment. It is to improve diagnostics as we are seeing with development of multiparametric MRI and molecular/genetic markers to make screening and treatment selection smarter. I fear that if this is not more widely accepted and the current situation continues, it is helpful that so much research is being conducted in the management of men with high-risk, oligometastatic and advanced disease, because it will be more and more of these cancers that we will be treating.

 

Dr Daniel Moon is Director of Robotic Surgery at the Epworth Healthcare, and a Urologist at the Peter MacCallum Cancer Institute, Melbourne
@drdanielmoon

 

 

 

Article of the Month: The Melbourne Consensus Statement

Every month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, we feature a video from Tony Costello and Declan Murphy discussing the Melbourne Statement.

If you only have time to read one article this month, it should be this one.

The Melbourne Consensus Statement on the early detection of prostate cancer

Declan G. Murphy1,2,3, Thomas Ahlering4, William J. Catalona5, Helen Crowe2,3, Jane Crowe3, Noel Clarke10, Matthew Cooperberg6, David Gillatt11, Martin Gleave12, Stacy Loeb7, Monique Roobol14, Oliver Sartor8, Tom Pickles13, Addie Wootten3, Patrick C. Walsh9 and Anthony J. Costello2,3

1Peter MacCallum Cancer Centre, 2Royal Melbourne Hospital, University of Melbourne, 3Epworth Prostate Centre, Australian Prostate Cancer Research Centre, Epworth Healthcare Richmond, Melbourne, Vic., Australia, 4School of Medicine, University of California, Irvine, 5Northwestern University Feinberg School of Medicine, Chicago, IL, 6Helen Diller Family Comprehensive Cancer Centre, University of California, San Francisco, 7New York University, 8Tulane University School of Medicine, Tulane, 9The James Buchanan Brady Urological Institute, Johns Hopkins University, USA, 10The Christie Hospital, Manchester University, Manchester, 11Bristol Urological Institute, University of Bristol, Bristol, UK, 12The Vancouver Prostate Centre, 13BC Cancer Agency, University of British Columbia, Vancouver, Canada, and 14Erasmus University Medical Centre, Rotterdam, The Netherlands

• Various conflicting guidelines and recommendations about prostate cancer screening and early detection have left both clinicians and their patients quite confused. At the Prostate Cancer World Congress held in Melbourne in August 2013, a multidisciplinary group of the world’s leading experts in this area gathered together and generated this set of consensus statements to bring some clarity to this confusion.

• The five consensus statements provide clear guidance for clinicians counselling their patients about the early detection of prostate cancer.

 

Read Previous Articles of the Week

 

Video: Why the Melbourne Statement?

The Melbourne Consensus Statement on the early detection of prostate cancer

Declan G. Murphy1,2,3, Thomas Ahlering4, William J. Catalona5, Helen Crowe2,3, Jane Crowe3, Noel Clarke10, Matthew Cooperberg6, David Gillatt11, Martin Gleave12, Stacy Loeb7, Monique Roobol14, Oliver Sartor8, Tom Pickles13, Addie Wootten3, Patrick C. Walsh9 and Anthony J. Costello2,3

1Peter MacCallum Cancer Centre, 2Royal Melbourne Hospital, University of Melbourne, 3Epworth Prostate Centre, Australian Prostate Cancer Research Centre, Epworth Healthcare Richmond, Melbourne, Vic., Australia, 4School of Medicine, University of California, Irvine, 5Northwestern University Feinberg School of Medicine, Chicago, IL, 6Helen Diller Family Comprehensive Cancer Centre, University of California, San Francisco, 7New York University, 8Tulane University School of Medicine, Tulane, 9The James Buchanan Brady Urological Institute, Johns Hopkins University, USA, 10The Christie Hospital, Manchester University, Manchester, 11Bristol Urological Institute, University of Bristol, Bristol, UK, 12The Vancouver Prostate Centre, 13BC Cancer Agency, University of British Columbia, Vancouver, Canada, and 14Erasmus University Medical Centre, Rotterdam, The Netherlands

• Various conflicting guidelines and recommendations about prostate cancer screening and early detection have left both clinicians and their patients quite confused. At the Prostate Cancer World Congress held in Melbourne in August 2013, a multidisciplinary group of the world’s leading experts in this area gathered together and generated this set of consensus statements to bring some clarity to this confusion.

• The five consensus statements provide clear guidance for clinicians counselling their patients about the early detection of prostate cancer.

 

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