By Roland Muntz, President of ANAMACAP, France
Translated by Christian Arnold, edited by Judy Higgins

Historical background 

Before the start of PSA blood testing (discovered in 1979 by Wang), prostate cancer could only be diagnosed through rectal examination – not well received by patients -nor by their GPs. Consequently prostate cancer was generally diagnosed at the metastatic stage (concurrent with bone pain) and led to men’s death in horrendous conditions.
From 1990 well publicised campaigns were launched in the US about PSA screening followed by biopsy, which made possible the diagnosis and treatment of large numbers of aggressive cancers. The death rate due to prostate cancer duly decreased.
But after some years using intensive screening, rates of aggressive cancers (linked to high levels of PSA) diminished; focus was then placed on patients with PSA levels lower than before. As a consequence, many false positives were found, leading to overtreatment of benign prostate cancers after unnecessary biopsy – these slow­growing cancers were not at that time identified as such.
In 2012 the US Preventive Services Task Force, while recognizing PSA screening had shown real results in terms of decreased deaths, emphasised that the negative consequences could surpass benefits when looking at quality of life. And as a surprise to both patients and doctors, US PSTF decided to stop recommending PSA testing. Other countries followed without argument. The outcome was obvious: return to a time prior to PSA, seeing more and more prostate cancers diagnosed at a late stage, not to mention metastatic cancer.
Faced with such a disastrous turn, the US PSTF are this year reversing these erroneous guidelines. Other countries are to follow, with a particular position for France, which is resisting, with guidelines issued by Haute Authorite de Sante (HAS) hostile to PSA screening. Despite this, the test is widely used in France – but in an anarchic way.

What is the current problem?

A common mistake lies in the simplistic definition of PSA test value. It is not a specific test of prostate cancer but merely a measure of prostatic disorder, and for prostate cancer it is a grading test, indicating a need for follow up tests.
The chance of prostate cancer diagnosis following blood PSA test are now well known:

In the overall population 70% of men over 40 years show a PSA level <1.5 ng/ml and can safely be monitored with PSA testing every 4 years. The real danger begins within the 1.5 to 4 ng/ml range, but risk doesn’t mean cancer, and even when cancer is present, radical treatment is not always necessary; often active surveillance can be enough. In this respect PSA is a marker of risk and not a starting point for biopsies and cancer treatment.

The real issue is primarily educational. PSA tests are prescribed by GPs upon (or without) patients’ demand. In France, HAS guidelines require that prior to testing, GPs discuss the pros and cons of PSA testing with patients. Are they doing the same when they prescribe a cholesterol analysis, blood pressure or weight measurement for more widespread illnesses such as diabetes, hypertension and obesity? In no way! In these cases they discuss treatment after results are made available.

Results should be handled in the same way with PSA and prostate cancer. In 70% of cases PSA will be below 1.5ng/ml – no need to discuss at length in these cases, the patient will be asked to revisit PSA testing 4 years later.

When the result is > 1.5 ng/ml, draw no hasty conclusions: this level means merely that the patient is more at risk of prostate cancer. He will be asked to retest every year or to seek additional tests for a diagnosis. The goal being, as far as possible, to avoid unnecessary biopsies (over-diagnosis) whose outcome can sometimes be serious infection, which in France alone takes a toll of 10 deaths every year.

When millimeter-sized adenocarcinomas are discovered within the prostate following a biopsy, no hasty therapy decision should be made: such a diagnosis means the patient is at risk of developing an evolving risk (metastasis 15 years later). A detailed grading with regular surveillance every 6 months will be proposed to that patient, or otherwise a conservative treatment. The purpose of this is to avoid pursuing radical treatments automatically, particularly prostatectomies, which take a toll of almost 400 deaths annually in our country, not to mention clear after-effects (urinary and/or sexual). This death rate comes to 10,000 deaths in 20 years, aside from the illness itself. As a comparison ‘mediator’ was responsible for 1,800 deaths over 33 years. Where is our Irène FRACHON ? (whisleblower who revealed the ‘mediator’ case in France)

A solution

Currently, imaging advances for prostate (multiparametric MRI) and centralised reading availability allows not only the detection and location of a given tumour, but also measures its aggressiveness, which both justifies and finely-tunes subsequent biopsies. In such a way, over-diagnosis (too many negative biopsies; due to false-positive PSA) would be reduced and overtreatment (aggressive treatment of benign cancers) would also be reduced.

Monitoring of prostate screening is as important as for any other screening programme:

• reimbursement of cost of PSA testing only when asked by National Health Service (Assurance Maladie in France), except for registered cancers
• stopping reimbursement of unnecessary (and often spontaneously prescribed, by any practitioner) free/total PSA tests, similarly for costly testing for markers of second stage (like PCA3, Phi), taking into account imaging advances.
• MRI should be processed within agreed centers in a programme, as mammograms are, in order to avoid multiple prostatic MRI prescribed in a disorderly way without reason;
• Analysis and monitoring by HAS of measured pros and cons of prostatectomy when a cancer is detected, registered and managed.

Today, available tools allow us to raise both the sensitivity and specificity of prostate cancer screening to levels over 95%. No other cancer enjoys such levels of efficiency in screening.

Consequently, the prostate cancer screening issue can be looked at in a new way that questions former positions of opponents to screening.

There is an urgency ‘to stop such a massacre’, shouted again this year by a professional opponent to screening of prostate cancer, as if a blood analysis made from the crook of the arm could be the cause of any death!

Because of such dogmatic positions, we are led to witness real massacre, with almost 9,000 deaths every year in France, due to a lack of early diagnosis, and more than 10,000 men left disabled following prostatectomies without any clear benefit in terms of survival.  In addition, huge financial amounts spent on unnecessary invasive treatments  and new priceless molecular therapies. And whatever solution we arrive at, it must be better than falling into unmonitored screening:

‘What have you done? Nothing’ said Simone Veil to her opponents (on the abortion issue in 1974 in France), contrite when facing the truth that they were keeping to themselves.

All the ones concerned by the screening issue watch each other, awaiting any move on this subject to criticize in order to preserve their interests.

Many of our doctors, either GPs, urologists or oncologists are not interested in this issue to avoid any dispute and debate and at the end are satisfied with a status quo that protects their professional life: GPs, thanks to HAS guidelines hostile to screening feel free of any responsibility; biologists take advantage of disorder in PSA or free PSA testing prescriptions; urologists enjoy large revenues drawn from prostate cancer and oncologists are pampered by big pharma, who are producing new molecules for hormone or chemotherapy.

Patients and their natural spokesmen, institutions such as ANAMACAP, have to shake this conservatism in order to drastically reduce rates of unnecessary biopsies, prostatectomies and radiotherapies, along with metastatc cancer with all its long-haul treatments.

The Ministry of Health must listen to these words kindly, because they match the  absolute priority included  within its global prevention policy. Along with the Chairman of our Scientific Board (Prof. Olivier Cussenot), I ask him to listen to us in order to draft a strategy, which would produce great savings for our country’s budget, and moreover, would be an important step in monitoring the coming prostate cancer epidemic.

Roland Muntz, President of ANAMACAP, France