EUROPA UOMO / Did You Know? N°3/2016 1

The new Board looks ahead with a three year Strategic Plan:

Ken Mastris John Dowling André Deschamps

Ekke Büchler Will Jansen Christian Arnold

Stig Lindahl

Chairman Secretary Treasurer Vice Chairman Vice Chairman Member Member UK Ireland Belgium Austria The Netherlands France Sweden

Contents

p.1 Editorial p.2 Chairman’s Letter p.3 Estonian Prostate Cancer Society p.4 Re-evaluating PSA Testing Rates in the PLCO trial p.5 Surge in aggressive prostate cancer cases. p.6 The search for new markers to identify aggressive

prostate cancer p.7 Prostate Cancer Units Network News Flashes p.8 Local Men Raise over £1100 for Rory The Robot Prostate

Cancer Appeal Fund p.9 Milano Conference on Active Surveillance p.10 The positive experience of an Active Surveillance patient p.11 Psychological aspects in Active Surveillance p.13 A Patient’s Dilemma

Editorial Malcolm G. Duncan, the Newsletter Editor

The September edition of the Newsletter appropriately opens with the Chairman’s Letter in which he rightly praises our Dutch colleagues for a truly remarkable annual assembly which was organised in the city of Hoorn. The opening article is dedicated to our new member association of Estonia to whom we send our very best wishes.

The two principal items on the agenda regard the partial re-election of the Board and the discussion and approval of the first draft of a three year Strategic Plan which aims to sensitize national and European authorities on the constant growth of

Did You Know? – N°3 – September 2016

The voice of prostate cancer patients across Europe

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prostate cancer among the male population and the common information and medical shortcomings in the 24 European member States which have associations soliciting numerous improvements in the care and treatment of prostate cancer. A disease which is contracted on the average by one man out of six or seven. The most important innovation would be the introduction of early detection which, at present, is only foreseen in 3 member countries, though the UK hopes to be the fourth country shortly thanks to its excellent relations with the British authorities and the mass media. Many of the other present shortcomings will be subsequently overcome, above all the problem of limited awareness. The urgency is confirmed by the recent surge in cases of aggressive prostate cancer as reported by The Times.

While the UK is striving to achieve early detection with PSA screening tests, America still expresses its misgivings on the accuracy of such screenings. On the other hand the San Raffaele Hospital in Milan is working on a possibly more accurate substitute for the PSA which should also indicate whether the prostate cancer is of an aggressive or benign nature. This is most important in order to avoid overtreatment and unnecessary surgery.

Three articles are in fact dedicated to Active Surveillance including the experience of an Active Surveillance patient. Another important novelty regards the setting up of a Prostate Cancer Units Network organised by ESO (the European School of Oncology) and covering the whole of Europe. It is thus hoped to dissuade patients from opting for local hospitals which deal with few patients and are probably less equipped than the specialized MultiDisciplinary Centres now available in several member countries. This is a common complaint in Germany which has around 100 such specialized centres spread throughout the country.

This edition has a number of News Flashes advising diet care to counter-act putting on weight, especially around the waist; the need for regular tests of patients following Active Surveillance therapy as lackadaisical attitudes could prove fatal; ongoing research to obtain a universal cancer vaccine; a UK petition recommending PSA tests to all men once they have reached 50; and the suspension of penalizing USA doctors for recommending Prostate Cancer PSA screening tests.

The Newsletter ends on a positive note and the success of three men who raised £1,100 with the help of a robot called Rory; the re-assurance of an English

patient who underwent radiotherapy treatment; and last but not least the humorous tale of an Italian patient which nonetheless contains numerous home truths, and a dilemma caused by neglecting to have an advised early detection screening test which however came to a happy end.

I have decided to step down as Editor of our Newsletter as from this issue for personal motives and wish my successor every success. The Chairman’s Letter

Dear friends,

Best wishes to all of you: member associations, their supporters and other addressees and, in particular, to our new member, Estonia, which increases the number of national associations dedicated to the problem of prostate cancer to 24. Increases to our membership is in fact one of our top priorities. The meeting in Hoorn was most rewarding and enjoyable thanks to the wonderful organization by our Dutch member association and we thank them for all their efforts to assure a most memorable annual assembly.

One of the main items on our agenda was the election of the Board and we welcome our two new members Will Jansen (the Netherlands) and Stig Lindahl (Sweden), as well as the confirmation of Christian Arnold (France) for a second three year mandate. We are sorry for the loss of Max Lippuner who decided to stand down and of Malcolm Duncan, notwithstanding his commitment to Europa Uomo which included the creation and subsequent editing of our quarterly newsletter “Did You Know?” in order to improve communications, participation in the Project Committee which prepared the first draft of a three year Strategic Plan for the approval of the general assembly. He stressed the importance of introducing “Early Detection” in all member countries: at present in force in only 3 countries. This urgency is confirmed by an article which recently appeared in The Times on the surge of aggressive prostate cancer and which is mentioned in this issue. We hope that such a positive development will assist Europa Uomo in its fund raising objective and improve male knowledge of this deadly disease which is suffered on average by one man out of 6 or 7. Last but not least a report on the Board’s activities in the previous twelve months was published for the first time. It has been one of my major objectives for years in order to improve relations between the Board and membership.

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Following the resignation of Malcolm as Editor, the board is hoping to find a volunteer to take up this challenge with the support of an editorial committee. It is clear that our secretariat, Anja, and our webmaster, Nancy, will continue to provide enthusiastic support for the editor and his committee.

I would like to take this opportunity to thank Malcolm for all his hard work over the years in producing the newsletter and to thank Max for his dedication to the goals of Europa Uomo.

Best regards, Ken Mastris, Chairman Europa Uomo

Our chairman, Ken Mastris, and Prof. Louis Denis attended the General Assembly ECPC, last June 3-5, 2016 in Brussels.

Estonian Prostate Cancer Society Dr. Tormi Soekõrv & Kalev Lehtla

Our story has a similar beginning to many other patient support organisations. In 2005 Kalev Lehtla, one of the founders of Estonian Prostate Cancer Society (EPCS), was diagnosed with prostate cancer and after consultation with oncologists decided to have his prostate surgically removed. After being diagnosed and before the operation he went through a lot mentally and came to grips with being mortal and the possibility of death. So when two weeks after his surgery to his surprise the doctors told him he was a healthy man and could go back to work, he was really surprised. He did just that and decided to leave the disease behind him.

He did so for quite a number of years, until in 2013 the disease caught up with him and had already spread to his bones. That is when he felt that this disease should be brought to daylight and addressed more publicly. He was one of the first men in Estonia to speak freely about prostate cancer and what he had gone through. When after his first few interviews men he did not know started calling him and asking for support or information about the disease he decided to create a patient organisation for people who suffer from prostate cancer.

He found some people who shared his belief and created a non-for profit organisation with a mission to have prostate cancer be recognised as a chronic disease. His wish is that other men could learn from his mistakes and could always benefit from early detection of the disease.

After our organisation was officially formed (during oncology week in October 2015), we got on a roll of different media publications. Kalev went on national television with his story and mission and also had many different popular magazines and newspapers do interviews with him. Thanks to all the attention, national television of Estonia and Estonian Cancer Society turned to us in late November, with an offer that we could not refuse. The annual national fundraiser was supposed to be collecting money for a mobile melanoma diagnostic centre, but the organisers were worried that they might not get enough support for the idea. So they turned to us and offered to make the fundraiser a combined mobile

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laboratory with different laboratories and rooms for prostate cancer diagnosis and melanoma diagnosis.

We agreed to help and the fundraiser was a massive success. As a result on 28th June 2016 two separate mobile laboratories were bought – one for melanoma and one for prostate cancer. The prostate cancer laboratory has a room for taking a blood sample from patients and in another room there is a PSA testing machine. That makes it possible for the doctor to give fast feedback to the patients. The mobile laboratories were given to Tartu University Clinics which started going around rural areas to offer diagnosing to those people who cannot for some reason travel to bigger cities.

Side view mobile lab

Backside mobile lab

Patient room mobile lab

With the first birthday of our organisation coming up we feel we have had a strong start, but we do not plan on standing still. Now we are looking for some

ways to offer PSA testing to those who do not have medical insurance (people who are not working and not yet retired, also many who have jobs outside Estonia and can’t therefore use national medical services.

We have been in the process of making a website for a few months now and hopefully it will be ready by our organisation’s first birthday.

Another thing we are working on is getting some information printed in Estonian. We got some good ideas from the Donor’s Day PKS during EUOMO General Assembly in Hoorn about some books that might be worth translating into Estonian. It seems to us, that it would be a good idea to have two different types of brochures or even books – one for men and one for the wives who are often the ones who start looking for information.

Our main problem on the table is how to get the men that come to us when they get first PSA tests to participate in our organisation after they get treatment. When they have no problems, it seems they see no need for our support. But that seems to be a question that everyone is trying to solve. And hopefully, whoever finds the answer will share it with others!

Re-evaluating PSA Testing Rates in the PLCO Trial J.E. Shoag, M.D. & S. Mittal, M.D., New York Presbyterian Hospital, New York, NY Jim C. Hu, M.D., M.P.H., Weill Cornell Medical College, New York, NY N Engl J Med 2016: 374; 1795-1796

In March, the Centers for Medicare and Medicaid Services temporarily suspended the development of a proposed “Non-Recommended Prostate-Specific Antigen (PSA)–Based Screening” measure that would discourage PSA screening in all men. The U.S. Preventive Services Task Force (USPSTF) is currently in the process of updating its recommendations for prostate-cancer screening. The decisions made by these two organizations are likely to determine the fate of PSA screening in the United States.

Much of the controversy surrounding screening revolves around the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, which randomly assigned men to annual prostate-cancer screening or usual care and showed equivalency in

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the primary outcome of prostate-cancer mortality.

The major criticism of this trial relates to the degree of PSA testing in the control group as reported in the 2009 publication of the trial results. Subsequent analyses, including the 2012 USPSTF recommendations, have interpreted the rate cited in the 2009 report as “approximately 50% of men in the control group received at least 1 PSA test during the study.”

This is an inaccurate interpretation of PSA testing in the control group during the trial. Rates of testing during the trial were determined by a follow-up survey, termed the Health Status Questionnaire (HSQ), that was administered to a subgroup of participants in the control group.

In the HSQ, men were asked whether they had ever undergone a PSA blood test for prostate cancer, along with follow-up questions about when and why the test was performed. Categorical responses for when the most recent test was performed were within the past year, 1 to 2 years ago, 2 to 3 years ago, more than 3 years ago, and I don‘t remember, and responses for the main reason for the test were because of a specific prostate problem, as, a follow-up to a previous health problem, and part of a routine physical examination. In the landmark 2009 trial report, the rate of testing in the control group was limited to men who responded that they had been tested within the previous year as part of a routine physical examination, and other responses were not counted as testing.

As seen in Figure 1, more than 80% of the participants in the control group without baseline screening contamination (which for PSA was defined as ≥2 tests within 3 years before trial entry) reported having undergone at least 1 PSA test during the trial, with more than 50% undergoing testing within the past year and 70% within the past 2 years. Overall, including the 10% of control participants with baseline PSA screening contamination, the proportion of control participants who reported having undergone at least 1 PSA test before or during the trial was close to 90%. Moreover, the pervasiveness of PSA testing was such that when

Figure 1: Prostate-Specific Antigen (PSA) Testing in Participants without Baseline Screening Contamination in the Control Group of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening

Trial

both trial groups were surveyed with the HSQ, men in the control group reported having had more cumulative PSA testing than men in the intervention group (see the Supplementary Appendix, available with the full text of this letter at NEJM.org).

These clarifications should be considered by policymakers and payers debating reimbursement and the meaningful use of PSA testing, particularly given the mounting evidence that intermittent PSA testing decreases the costs and harms of screening while preserving the benefits of annual testing. Surge in aggressive prostate cancer cases The Times 22/07/16

More men should be screened for prostate cancer after a massive rise in cases of the potentially fatal disease spreading, a report warned.

The study shows the number of new cases of metastatic prostate cancer in the United States soared by 72 per cent from 2004 to 2013.

The highest increase (92%) was among men aged 55 to 69, who could benefit from early treatment.

Metastatic prostate cancer is cancer that has spread to lymph nodes in other parts of the body or bones but sometimes also to other organs.

The report, published in Prostate Cancer and Prostatic Diseases considers whether fewer men

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being screened may be contributing to the rise or whether the disease has become more aggressive.

The researchers said that the rise in cases among the over-55s was “particularly troubling” because men in that age group are believed to benefit most from screening and early treatment.

Men who had metastatic prostate cancer diagnosed in 2013 had higher levels of the disease than in 2004. Their average level of PSA, a protein produced by the prostate gland that is often elevated in men with prostate cancer, was 49 – in 2004 it was 25,

Edward Schaeffer, senior author of the study and head of urology at Northwestern University’s Feinberg School of Medicine, said “One hypothesis is that the disease has become more aggressive, regardless of the change in screening. The other idea is that since screening guidelines have become more lax, when men do get diagnosed it is at a more advanced stage of the disease. Probably both are true.”

The researchers found a substantial reduction in the number of men being screened for prostate cancer and an associated decline in the number of new cases being reported.

Dr. Schaeffer said:”The fact that men in 2013 who presented a metastatic disease had much higher PSAs than similar men in 2004 hints that more aggressive disease is on the rise”.

Patients with localised prostate cancer can be cured whereas treatments for metastatic prostate cancer tend only to slow the progression of the disease.

Adam Weiner, lead author of the study, said:”The results indicate that screening guidelines and treatment need to be refined based on individual patient risk factors and genetics. This also can help minimize over-diagnosing and overtreating men with low risk prostate cancer who do not need treatment.

In Britain, about one in eight men will get prostate cancer, according to the charity Prostate Cancer UK. The NHS says that patients have a 30 per cent chance of surviving the cancer if it has spread into the lymph nodes, bones and other parts of the body. About 20 to 30 per cent of cases reach this stage before being diagnosed.

SECRETARIAT Europa Uomo

Lange Gasthuisstraat 35-37, 2000 Antwerpen, Belgium Tel: +32 3 338 91 51 - Fax: +32 3 338 91 52

europauomo@skynet.be - www.europa-uomo.org

The search for new markers to identify aggressive prostate cancer Nazareno Suardi, Department of Urology, University Vita-Salute San Raffaele Email: suardi.nazareno@gmail.com, Twitter: @naza78

a view of San Raffaele Hospital in Milan

The usefulness of screening for prostate cancer to reduce metastatic progression and cancer-specific mortality has been largely debated in the last 5 years. The majority of studies have used the prostate specific antigen (PSA) as the most important marker for prostate cancer detection and characterization. However, it is well known that PSA does not represent the “perfect” marker, due to the high rates of false positive and false negative cases. Furthermore, the ability of PSA to correctly correlate with tumor aggressiveness, defined according to the Gleason score assignment as a pathological evaluation, is quite low.

In the light of these limitations, many researchers are trying to identify new markers for early diagnosis of aggressive prostate cancers. In the last 10 years, several markers have been proposed and tested such as -2pro-PSA, PCA3, the 4K-panel and others. On the other side, the relationship between sex hormones and prostate cancer development and progression has been studied for the last 50 years, but conflicting results have been reported and to date there is not a clear association between hormones and prostate cancer. Therefore, there is still a vivid ongoing research addressing the link between hormones and prostate cancer aggressiveness.

At the 2016 Annual Congress of the European Association of Urology (EAU) the interesting results of an Italian study has been reported (Abstract n. 170). The group led by Dr. Marco Moschini retrospectively correlated hormone levels and Gleason scores in 1017 consecutive patients who underwent radical prostatectomy surgery at the San Raffaele Hospital in Milan. Serum testosterone, 17β-estradiol and sex hormone-binding globulin (SHBG) were measured the day before surgery (8-10 A.M.). Of these patients,

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118 showed the most aggressive Gleason pattern 5 at pathological evaluation.

SHBG (41.8 vs. 37.5 mmol/dL) and the rate of hypogonadism (32.0% vs. 21.4%) were higher in patients harboring Gleason pattern 5 at pathology. At multivariable analyses, SHBG levels (OR: 1.02, p=0.03) were able to predict the presence of pathological Gleason pattern 5. Moreover, after adjusting the analyses for age, for the d’Amico et al. pre-operative risk groups and for SHBG levels, the presence of hypogonadism, defined as total testosterone level <3 ng/ml, was independently associated with the presence of pathological Gleason pattern 5.

SHBG, or sex steroid-binding globulin (SSBG) is a glycoprotein that binds to the two sex hormones: androgen and estrogen. SHBG is produced mostly by the liver and is released into the bloodstream. Other sites that produce SHBG include the brain, uterus, testes, and placenta.

This study shows that that hypogonadism, and the levels of SHBG, were able to predict whether or not patients had Gleason factor 5, which is the worst Gleason score. This association will allow us to predict what the outcome will be before we decide to treat a patient with surgery. Potentially this can be helpful to identify patients with the most aggressive prostate cancer before surgery. On the other hand, the results of the study indicate again that there is urgent need for new research to uncover the role which hormones play in prostate cancer development.

Prostate Cancer Units Network

The Prostate Cancer Units Network is the first international network of clinical units dedicated to the diagnosis and treatment of prostate cancer. The project is an initiative of the European School of Oncology in partnership with Europa Uomo – the European Prostate Cancer Coalition – with the aim to promote the multidisciplinary and multiprofessional management of prostate cancer patients.

http://www.prostatecancerunits.org/

NEWS FLASHES Active Surveillance and Metastases A recent study published in the Journal of Urology (vol. 195 -2016) reports that metastases may develop in a small proportion of active surveillance patients. The risk is significantly higher in some men with a Gleason score of 7.

Hot Sheet Us TOO, 6/16 Obesity increases risk of prostate cancer A 14 year study carried out by Oxford University, covering 8 countries and involving 150,000 men, showed that every four inches increase in a man’s waist, typical of a beer belly, increases the man’s exposure to prostate cancer. The extra weight on the waist appeared to have an impact on hormones which fuel prostate disease and affect the metabolism.

The Daily Telegraph, 2/6/16 Active Surveillance is Often “Not” A new study suggests that body risk of prostate cancer may be higher than expected in men categorized as having a low risk disease, also as only one man out of three receives appropriate follow up tests. With Active Surveillance both patients and providers tend to get a little lackadaisical said Gregory Auffenburg, MD, from the University of Michigan.

Hot Sheet, Us TOO, 6/16 Immune cell vaccine could help against all cancers A universal cancer vaccine is on the horizon after scientists at the Johannes Gutenberg University in Mainz, Germany, discovered how to rewire immune cells to fight any type of cancer. The potential new therapy involves injecting tiny particles of genetic code into the body which travel to the immune cells and teach them to recognise specific cancers.

The Daily Telegraph, 2/6/16 Medicare suspends the proposed penalty for recommending PSA Tests The Centers for Medicare & Medical Services (CMS), USA, has temporarily suspended the development of the proposal that would have penalized physicians for performing “non-recommended” prostate cancer screening with the PSA test.

Hot Sheet, Us TOO, 6/16

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Melanoma skin cancers Britons in Brittany have been warned to take special measures to avoid UV rays and do so even when it is cloudy. Scientists have found that melanoma skin cancers are more than twice as common in Britanny as on the French Riviera. In 2914 there were 1,305 cases in Brittany against only 585 cases on the Riviera. It is partly a problem of light skins and blue eyes. Creams are not the answer. The best protection is clothing. Researcher in Nice have found a molecule, still subject to testing, that may kill skin and other cancers.

The Connexion, Summer 2016

Learn more: https://platform.emergingmed.com/find-clinical-trials/bayer#partnerhome

Local Men Raise Over £1100 For Rory The Robot Prostate Cancer Appeal Fund Paul Markell, Treasurer, Kidderminster and Worcestershire Prostate Cancer Support Group. Hugh Gunn, Trustee, Tackle, UK

Three local men have raised over £1100 through a collection at local supermarkets to help Worcestershire men with prostate cancer in future.

£1171 was raised over two days by Brian Wilkes, Ian Jukes and Paul Markall, all part of local appeal Rory the Robot. The Rory the Robot appeal is a campaign to raise £1.6 million to buy a state of the art surgical robot to treat Worcestershire men with prostate cancer. With Rory's assistance, patients will benefit from less pain, minimal blood loss, quicker recovery and reduced complications.

Rory, the Robot

The collection was held at the Morrison’s store in Hereford on Friday 12 and Saturday 13 February with local shoppers digging deep to donate. Many of the customers who contributed had stories to tell themselves of friends or family who have been affected by prostate cancer. Mr Wilkes, who works at Morrison’s in Bromsgrove has also organised other collections and bag packing events covering 11 stores over Herefordshire and Worcestershire this year. Ian Jukes, Chairman of the Rory the Robot appeal said: “The appeal is very close to our hearts and of many others in the county too. We’re very grateful for the public’s generosity and all those who have supported us so far. We’re very excited for the upcoming events and hope that they will be as successful as this first one!” Letter 1

Dear Editor,

I am reading the latest issue of Prostate Matters. I read with interest Robin Kent's letter. In February last year I had my prostate removed (psa 56 Gleeson 6 ish). Unfortunately my next psa in May

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was .75 and I was told to have 33 daily sessions of radiotherapy at the Churchill hospital between 9th July and 24th August. All seemed to be ok but halfway through I couldn't pass urine and had to have a catheter fitted (by Stoke Mandeville hospital). This also caused problems having a clamp fitted to regulate my flow. The catheter was due to be removed early in September but after a few hours I couldn't go again and another one was fitted. This also happened in October and only after a small op in December could I dispense with it, although I am still wearing incontinence pads. I read with interest that in Birmingham they check to see that the bladder is full before each treatment. This does not happen at Oxford, and I wonder if this might have helped my specific case. By the way my psa in October was .92 but at the last count recently was down to .34 fortunately.

Regards, Richard Reply

Here Is the reply from Roger Wotton. His reply is as a patient who has had similar treatment - Not as a Clinician:

Richard, just a follow-on from your letter. I just had my monthly follow up phone call with the lead radiographer at Mount Vernon. While on the phone I asked him about current protocols around normal (external beam) radiotherapy. It was interesting. He said traditionally the radiotherapy was done on a full bladder but in the past 12 months there is a trend to do it with an empty bladder as they become more expert in the techniques. Evidence so far is encouraging and shows no difference in outcome between full bladder patients and empty bladder patients. It's probably the approach you had in Oxford (empty) compared to Doug Badger's in Birmingham (full). What he said was that each patient is different and it depends what area they treat - prostate only or pelvic area included. There appears to be no difference in side effects for full or empty bladders. It is just a fact that a percentage of patients will get side effects irrespective of full or empty approach and it does appear you were unlucky. As indeed I was when I had six weeks of bladder bleeding one year after traditional radiotherapy - the same treatment as yourself. I hope this helps.

Regards, Roger Wotton

Milano conference on Active Surveillance Translation from the Swedish ProstataNytt Calle Waller

More and more men with newly diagnosed low-risk prostate cancer are nowadays recommended to refrain from radical treatment in the form of radiation or surgery. Instead, they are offered a so-called active surveillance alternative, AS, with a systematic follow-up. The reason is that the risk that low-risk cancer develops further into metastases is extraordinarily small. The benefit of AS is understood that many will not have radical treatment and thus avoid the inherent risks in the form of treating as injuries and side effects.

Since AS for low risk prostate cancer is now recommended as a first option, we can predict that this trend will continue to grow. Of the more than 10,000 who were diagnosed in Sweden during 2014, 2500 chose to await treatment and instead opted for AS. In a few years, a large proportion of the 100, 000 men then living in Sweden with the diagnosis will be treated by AS. It is therefore high time that we get ourselves better informed on healthcare management, when it comes to informing and supporting men in their decision-making and how the protocols for follow-ups looks and is applied. To take advantage of the benefits and avoid the risks we also need more research and exchange of knowledge-

One step was taken on 11-12 February when the EAU, European Association of Urologists, and ESO, the European School of Oncology, jointly organized a conference gathering some 100 experts from Europe and the US, precisely to discuss Active Surveillance, ie AS. Numerous studies were reported, interspersed with discussions about the value and applicability.

In summary, one can say that unity of opinion was general about refraining from active treatment of low-risk cancer, but that many question marks remain to straighten out when it comes to handling

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the situation. Here are some examples of what was discussed:

- A large consensus that the majority of men with low-risk tumors in utilizing AS will live the rest of lives without further disease symptoms.

- In contrast, there is growing skepticism with AS in men with intermediate risk tumors (Gleason 7) due to the high risk of metastasis.

- Up to 30% will sooner or later get signs of disease progression and therefore need treatment. They then have saved some time without side effects, but also risked the disease developing further, or in the worst case passed the possibility of a definite cure.

- A number will cancel or fail to follow their AS program. It can be difficult to live with the realization that you have a cancer in your body, albeit not aggressive. Or maybe you want to forget about your illness completely. An important question is how to follow up on these attitudes.

- The decision to select AS requires that the patient has been well and repeatedly informed. Men who have had discussions with other experts show more confidence in their choice. Even here, then, a second opinion is recommended.

- Follow-up protocols can vary, but should at least consist of regular PSA tests and biopsies. Unfortunately, biopsies are not at all harmless. The risk of serious infection is becoming more common due to resistant bacteria.

- MpMRT, multiparametric MRI is an imaging technique which is expected to reduce the need for biopsies. The idea is that thanks to this MRI method you can determine if the biopsy is necessary at all and how it, in this case, should be effected. Unfortunately more study is required before the method can be fully recommended.

- Tumor genetic imprints are studied in many projects. It is expected that this will become the next step forward to safer prognosis and treatment options.

- A tumor with a Gleason 3+3 is not expected to metastasize. The problem is that you can never be absolutely sure that the value is "exact".

- The international organization Movember is funding a worldwide project, GAP3, in order, among other things, to develop an international standard for follow-up protocols in AS.

Professor Jonas Hugosson at the University of Gothenburg was one of those who led the Milan

Conference. From Sweden Prof. Sigrid Carlsson, Associate Professor and researcher at Memorial Sloan-Kettering Cancer Center also starred, as well as Kimia Kohestani, a doctoral student at the University of Gothenburg. In the photograph the legendary urologist Louis Denis is also present, one of the founders of our European organization Europa-Uomo.

Photo: From left, Calle Waller, Prof. Jonas Hugosson, Kimia

Kohestani, associate professor Sigrid Carlsson, Prof. Louis Denis

The positive experience of an Active Surveillance patient Jan Humblet, US TOO Belgium

This presentation explains my experience as a patient who finally, thankfully with the support of many, opted for “active surveillance” (AS) as the treatment of my low-risk prostate cancer (PCa). I’ll talk about the difficult way that I followed from the diagnosis of PCa to the not obvious decision to opt for AS.

I speak about the emotional and the social problems I faced as a patient. Only the word “cancer” caused fear, uncertainty and confusion. In my case the panic was clearly reinforced by a lack of basic knowledge about PCa.

Fortunately, I owe much to the information I have learned on joining a peer support group (US TOO Belgium). The group experience offers a place to belong to and to express feelings of fear and confusion. I especially learned that there is no one-fits-all approach for PCa. That means that while some require urgent and aggressive treatment, there are

EUROPA UOMO / Did You Know? N°3/2016 11

many who can slow down and take an AS approach. I also learned that in my case there was no reason for a hasty decision and that the risk of overtreatment with various undesirable side effects was real.

In addition to a brief description of the medical monitoring of AS, an overview of the key elements of an appropriate lifestyle are given to the patient. A modified lifestyle is essentially a matter of common sense: move, eat healthy and inform yourself about your physical condition. All these elements are included in a global life style project designed for PCa patients with the appropriate name: FEEL+. As US TOO Belgium, we promote and practise systematically physical exercises indicated in the FEEL+ program. A brief overview is captured by the acronym JAMES, where the J stands for jogging (or walking), A stands for abdominal exercises, M for muscle exercises and S for suppleness training.

Feel+ exercises As patients we are aware of the fact that the objective of AS is to keep an option on curative treatment if needed. In that case, every possible treatment will run better if we have a good physical condition.

Psychological aspects in Active Surveillance Dr. Tania Estapé, FEFOC Spain

The treatment most understood and accepted among cancer patients and in the general population is surgery. Physically eradicate a tumour is something that many people see as necessary and thus assume that the evil is outside the body. It is much more understandable that sometimes complementary treatments such as radiotherapy and chemotherapy are preferable, especially if the latter is applied based on relapse prevention without tangible disease. If this is so, it is even more difficult to accept that the tumour is not removed or eliminated by any means, but opt to retain it in the body, in this case in the prostate. Active surveillance (AS) is an option in cases of slow growth and/or elderly patients. Of course it is not an aggressive option, and only requires active control of the disease. If in time the tumour advances the most appropriate therapeutic option is activated. But this involves a series of obstacles at psychological level that we shall now consider.

The decision to choose AS is difficult for the affected and their families as it elicits a chronic sense of insecurity. The patient wakes up every day knowing that he has cancer in himself and it's complicated to deal with this. Sometimes it may even lead to a denial, as the attribution of cancer as something horrible and that spreads makes the man, in the absence of symptoms, believe that perhaps it is not true. Studies show that after interviewing patients in AS there is a tendency to comment that “the tumour in my prostate is benign” since no treatment is required. There are thus patients that may prefer more aggressive options even if they have the possibility of AS and this is determined mainly by the following reasons: - The doctor does not support more or less explicitly AS - Family pressure to opt for active treatment - Pressure from the individual himself who prefers to fight the disease, because it is what we have learned, that you have to fight cancer. It is also a way to make sense of control, which is lost with the idea that AS gives that “nothing is done”. This is called self-efficacy and is the degree to which the patient perceives that is effective against the occurrence of the disease that correlates with a good mental adjustment to it.

The two most common psychological consequences in AS are uncertainty and anxiety, and both are

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closely related.

Uncertainty comes from the above mentioned feeling that the evil has not been eradicated and that is not under control, but is left to grow "at ease". We would say that the patient lacks clues about how one is normally expected to live with cancer, which is normally by aggressive and immediate treatment. Another aspect that has great weight in uncertainty is what we call making medical decisions. The patient is compelled to opt for a decision which is not a treatment. If it is already a difficult decision, and in prostate cancer where we often have elderly patients who come from a time when the doctor decided the best option for the patient. It was the era of so-called paternalism in which no option was given to the patient to decide. It is also true that there were fewer options than we have today. The shift to a more active participation by patients is slow and for many people it involves a high degree of uncertainty for fear of not choosing the best option. In the case of AS, since no precise therapy has been decided, uncertainty is total. It has been shown that uncertainty greatly reduces the quality of life of patients. As they are not receiving any conventional treatment, the patient fails to see any change in his life, because of the weight of the stress of the disease. Some men may comment that they feel they have inside "a time bomb" and this prevents them from enjoying life.

Closely related to uncertainty, high levels of anxiety are displayed. We've talked here of anxiety, but in this case the focus on the subsequent degree of nervousness regarding the tumour and trying to live a normal life. Uncertainty is a major precursor of anxiety. In this case it is determined by the ambiguity in the information (in the decision making the doctor give a series of information trying to be fair but also trying not to show favour for one or the other option). This situation drastically reduces the ability to handle situations for fear and indecision weigh much more than anything else in the mind of the patient. There are many studies on the degree of anxiety of cancer patients, some related to the PSA anxiety, others which appear as a result of physical symptoms that generate insecurity (eg. urinary incontinence). But in this case we refer to the anxiety generated by the decision and then for having chosen the "no treatment" option. The degree of anxiety experienced is high at first but some studies show that then it is reduced and that few men later opt for conventional therapeutic options because of their anxiety. We should add here that this type of anxiety sometimes feeds back with relatives who fear being

mistaken in letting your loved ones keep the tumour in their bodies which could lead to unwanted growth that could end their life.

Another source of anxiety in AS is fear of relapse. This is one of the great psychological problems in cancer and it may be increased by this non-therapeutic option. Some studies show that patients who receive the standard treatment option may experience a reduction of this fear of relapse, although in some cases it reappears on control visits. In AS cases, anxiety related with disease progression may lead to a drastic reduction in the quality of life if the patient is continuously reminded of the dangers of the disease.

We have to keep in mind that men who show more anxiety to the situation generated by the choice of AS are people with previous features of more neuroticism and high risk of stress. In other words, people with a tendency to worry, a characteristic already present before the diagnosis of cancer. Prostate cancer is a negative event that threatens the quality of life but the reactions to it, also depend on the personal characteristics of men. We must also include men with a history of generalized anxiety disorders, those with poor education and some other pre-existing conditions. These features lead men to be more prone to anxiety about prostate cancer and especially if the option is AS.

The paradox of AS is being seen as an option which is seen as a sign of medical progress because it avoids aggressive treatments and impaired quality of life. However it could create more stress than options much more disabling for the subject, such as treatments involving impotence and urinary incontinence. For this reason it is very important to work on several fronts to make the patient feel relaxed before the decision making and effectively able to enjoy life without being troubled by the consequences of this decision. In this sense, we propose the following: - Support groups: the assistance of groups where they can get information about the disease and to meet people who are going through or have gone through the same process and can therefore help to calm them down. These groups often have the advice of professionals. It is always better to be able to respond to different situations. - Participatory management of everything related to the disease: it is important for the patient to have the feeling that everything is under control. One way to achieve this is to maximize the psychological support through group or individual sessions but also

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promote healthy behaviours and make the patient feel that he is "doing something" to prevent the disease from progressing. One aspect we have discussed that makes the patient feel anxious and insecure is the fact that AS makes him feel that nothing is being done.

Therefore, and as part of psycho-educational programs, we urge you to be active against the disease which comes from the establishment of healthy behaviours. Several studies are analysing the inclusion of global programs within the same group of psychological support, where it impinges on activities such as exercise, diet changes and stress reduction techniques. Early results show an increase in the quality of life of patients with AS who follow these programs versus those in the control group who only attend scheduled visits. Start and stick to healthy behaviours is a way to feel active and fighting against the disease, which is perhaps what patients notice that they lack when have opted for AS. Preliminary studies on this are few and recent but are pointing to an improvement resulting in more feelings of hope, optimism and an increased fighting spirit.

There is an important point we want to talk about. The option of AS sometimes leads to the use of alternative therapies, on the advice of family and friends, which is favoured by this feeling of "not doing anything". It is estimated that about 25% of patients will use this type of "therapies" and that most do not discuss them with their doctors. There is a wide range, from alleged healing treatments to supplements to enhance the immune system or "defences" which are supposed to prevent the cancer from progressing. It would be good to acquire a high level of communication regarding this, to prevent the patient from jumping visits or controls or end up using some unproven therapy.

AS concludes that the quality of life that is supposed to be improved by choosing the AS thanks to the lack of physical consequences. However this may be compromised by the high level of anxiety and uncertainty involved by no treatment and living with the idea that one has the tumour in his body. It is necessary to provide comprehensive programs in which patients and their families have the possibility of truthful information that allows them to gradually assume that the chosen option is best for them. Psychological support must be included to help eradicate erroneous beliefs and replace them with cognitions of the true situation. These programs also should include projects like the establishment and

adherence to healthy behaviour related to changes in diet and exercise. These have the dual purpose of helping psychologically by inducing lifestyles incompatible with anxious ruminations, and at the same time make the patient acquire a sense of self-efficacy against the disease. It would also be beneficial to achieve adequate communication programs on AS for physicians and other professionals in order to reduce anxiety related to decision making, and the AS option which means avoiding conventional treatments.

A Patient’s Dilemma Francesco MariaTesta A brief account by the above patient guilty of having neglected to effect an early detection, told in a reassuring manner in order to be positive and reflective

On Wednesday 1st October I have an appointment with a surgeon who intends operating me to reduce an excessive breast formation. Something quite unusual for a man. In the meantime he has prescribed a mammary ultrasound and a bilateral breast scan and also appropriate blood tests.

The first time that I let off steam with my family doctor, it was for the painful gynecomastia caused by Casodex which I had to take day after day in order to keep my PSA low. I lost my temper when he told me “Don’t worry, it is only of a secondary sexual nature”. “It’s almost like changing sex”, I replied in the same tone.

My story began on 31st January 2002 when an ultrasound control of the ulcerative rectocolite appeared out of the blue soon after the death of my wife after a sufferance which had lasted some 30 years. The gastroenterologist noted that my prostate had notably increased.

I wasted no time and though I had had no minimum pre-warning, I was operated on 4th April of that year. When my specialist for intestinal problems heard of my experience he told me that I had been very lucky as it could have gone much worse. I had survived also as, like most of us, I am greatly attached to life. Nevertheless I couldn’t avoid complaining to my GP who, notwithstanding the computer which dominated his desk, failed to warn his male patients to have a PSA test, especially once they reached the danger age.

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The second time that I experienced a swelling of the breasts, the specialist quite casually asked me why I wouldn’t accept a surgical operation. You know that such an operation is covered by the national health system. Sarcastically I replied, “What luck to have such a beautifying operation free of charge”.

One month later on the occasion of my annual check-up my surgeon friend asked me why I still put off the idea of the surgical operation, “After all”, he said,” you don’t and won’t ever have to milk a child”. I finally decided to take his advice and went to the breast division of a Florence hospital where I was surrounded by many members of the female sex. I soon realized that while we men are full of ridiculous reserves and embarrassment, this was not the case for our lifetime companions, free of any complexes and certainly more realistic and courageous. On the contrary I well remember the embarrassment of a friend of mine after prostatectomy when he went back home and had to put up with the classical allusive question accompanied by an eloquent gesture,” So, no more………..?” Encouraged by the friendly and understanding attitude of the women who had the same problem, and informed that cases like mine were quite frequent, I underwent the surgical operation in an entirely different manner.

Why is it that we always think that unpleasant experiences only happen to others. such as a serious illness, a car accident, or an accident at work?

Prevention is not a passive attitude. It implies our responsible and active manner in coping with problems and possibly resolving them, rather than pretending, out of embarrassment, laziness of a thousand other reasons, prefer to believe that the problem doesn’t exist.

I would like to conclude underlining the absurd Italian reality where the elevated mortality of the male sex may be caused by neoplasia provoked by prostate cancer, in part the consequence of a limited knowledge of the PSA test (fewer than 22% of the men in the dangerous years from 50 to 70). I repeat

once again that the PSA test is fundamental as was underlined in the international conference held in Milan mid 2015.

I exclude that this painful Italian truth depends on our indifference, but rather on a lack of knowledge and transparency, as no-one well informed would think of ignoring this disease and its possible cure.

Besides our unwillingness to expose ourselves, in my opinion much of the responsibility for this lack of information is due to a subtle institutional power in the hands of men who have our same prejudices and thus fail to take valid initiatives either to prevent or reduce the consequences of this disease which is constantly growing in dimensions. Otherwise all that was possible would have already been achieved.

We therefore must free ourselves from our cultural conditioning, face facts and support, even locally, those who think alike and sustain the right to enjoy the good health of the entire community.

GA 2016, Hoorn, June 17-19, 2016 © E. Briers

“The views expressed in this newsletter are not necessarily the views of Europa Uomo”

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Anja Vancauwenbergh, Newsletter Secretary, europauomo@skynet.be