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Follow-up of Prostatectomy versus Observation for Early Prostate Cancer
Surgery or observation?  731 men with localised prostate cancer were randomly assigned to surgery (radical prostatectomy) or observation.  After nearly 20 years of follow-up among those men who had surgery did not have significantly lower deaths from all causes or from prostate cancer than those who had followed the observation pathway.  Those who had surgery, however, had a higher frequency of adverse events than those who had observation, but on the other hand they had a lower frequency of treatment for prostate disease progression, mostly for asymptomatic, local, or biochemical progression.
Urinary incontinence and erectile dysfunction were each greater with surgery than with observation through 10 years.  Disease-related or treatment-related limitations in activities of daily living were greater with surgery than with observation through 2 years.
These study results are part of PIVOT (Prostate Cancer Intervention Versus Observation Trial).
See the full article in the NEJM:
http://www.nejm.org/doi/full/10.1056/NEJMoa1615869?query=TOC


Half of Urologists Unaware of New, More Sensitive Prostate Cancer Tests
Half of urologists surveyed were unaware of newer, more sensitive biomarker tests for detecting prostate cancer, according to a survey of 300 of the specialists worldwide.  The new tests reduce the need for invasive prostate biopsies.  They also allow doctors to identify early-on those patients whose cancer is likely to turn aggressive.
Dr. Nicolaas Lumen, head of the Urology Clinic at University Hospital Ghent in Belgium, presented the findings at the Global Congress on Prostate Cancer in Lisbon, Portugal, June 28-30.  He noted that while responses to the survey came from around the world, most of the participants were European urologists.
His keynote presentation, “Biomarkers in 2017”, revealed that nearly 50 percent of urologists do not recommend a diagnostic biomarker test to their patients.  The reason for this low percentage, according to the survey, was that many don’t know about the tests.  Ninety percent of the 300 urologists said they would use the tests if the diagnostic tools allowed them to rule out cancer with a very high level of certainty, however: “The new generation biomarker tests are more accurate to identify clinically significant prostate cancer and are valuable tools for further risk assessment to determine whether or not to proceed with biopsy,” he added. "[Dr. Lumen is associated with a company MDxHealth which markets a proprietary biomarker.]"
See full article:
http://globenewswire.com/news-release/2017/07/03/1037302/0/en/Keynote-Presentation-Reports-Lack-of-Knowledge-on-Clinical-Advances-Achieved-by-the-New-Generation-of-Biomarker-Tests-for-Prostate-Cancer.html

 

Side effects of Prostate Cancer Treatment – Urinary Incontinence and Impotence
By clicking on the link below it will take you directly to a 4,5 minute video presentation made in the US.
https://www.youtube.com/watch?v=_BHQIaoOzvo


Incontinence Exercise Programme
The link below will take you to a You Tube video lasting 2 minutes 20 second from Australia which discusses survivorship with the aid of an exercise programme to combat incontinence.
https://www.youtube.com/watch?v=cfaXoecaIjw


Big Pharma Spends on Share Buybacks, but R&D? Not So Much – NY Times
Under fire for skyrocketing drug prices, pharmaceutical companies often offer this response: The high costs of their products are justified because the proceeds generate money for crucial research on new cures and treatments.
It’s a compelling argument, but only partly true.  As a revealing new academic study shows, big pharmaceutical companies have spent more on share buybacks and dividends in a recent 10-year period than they did on research and development.  The working paper, published last month by the Institute for New Economic Thinking, is entitled “U.S. Pharma’s Financialized Business Model”.
The paper’s five authors concluded that from 2006 through 2015, the 18 drug companies in the Standard & Poor’s 500 index spent a combined $516 billion on buybacks and dividends.  This exceeded by 11 percent the companies’ research and development spending of $465 billion during these years.

NY Times Article: https://www.nytimes.com/2017/07/14/business/big-pharma-spends-on-share-buybacks-but-rd-not-so-much.html
Source Article: https://www.ineteconomics.org/research/research-papers/us-pharmas-financialized-business-model

 

EUROPA UOMO ACTIVITIES AND NOTICES
Wednesday 27 September 2017 - European Parliament Brussels
More information and registration at http://epad.uroweb.org/

Conferences:  The General Assembly in 2018 will take place in Malahide, near Dublin the capital of Ireland.  The date of the GA will be PM Friday 9 June.  There will be a delegate event on the following day, June 10 until late lunchtime.  This will allow for afternoon departures from Dublin Airport.  Attached to this Update are the list of airlines who currently fly to Dublin Airport.  Those who wish to extend their stay to Sunday or Monday will be offered the conference rate.  Men Against Cancer will have a suggested programme for those remaining on after the GA.

Vienna Patient Seminar 3 - Prof. Stephan Madersbacher
Oligometastatic Prostate Cancer - How should it be treated?
Before we consider what kind of treatment should be offered to patients with Oligometastatic Prostate Cancer perhaps we should pause for a moment to ensure that we have some basic understanding of Oligometastatic Prostate Cancer.  Without getting too technical this term oligometastatic applies to isolated prostate cancer lesions which are located away from the prostate bed - they are small in number and not sufficiently widespread or numerous to warrant designation as metastatic.  As to how many lesions you can have and still be regarded as oligometastatic may seem a bit like wondering how many angels will fit on the head of a pin so we can leave that to metaphysics.
 
Prof. Stephan Madersbacher gave a comprehensive and well argued presentation in Vienna on 10 June where he argued that oligometastatic prostate cancer warranted local therapy.  He compared the approaches used in colorectal, renal and glioblastoma cancers where cytoreductive surgery and/or radiotherapy improved survival and asked why should this not be offered for oligometastatic prostate cancer?

The rationale for local therapy is that it eliminates therapy-resistant, potentially metastatic cell clones and can be seen as the first step in a multi-modal therapeutic concept. 

Prof. Madersbacher addressed directly the question of whether radical prostatectomy should be performed on men with oligometastatic prostate cancer.  He presented the results of a number of studies on this matter and suggested that this approach, though a new therapeutic concept has acceptable morbidity and avoidance of local complications.  But he admits that the impact on overall survival is unclear.  Nonetheless, this approach is increasingly used although regarded as experimental, but a randomised clinical trial (RCT) is underway and some definitive answers should emerge in about 2-3 years.

The full set of slides of Prof. Madersbacher is attached to this Update.



July Board Meeting Report:
• Responsibility for the 7 projects approved at the General Assembly have been assigned to various Board members.
• The Board has accepted proposals from Men Against Cancer for the venue and arrangements for the GA in 2018 in Malahide, Dublin.
• A programme of attendance and representation at various conferences and congresses is being finalised for the period September 2017 until March 2019.  This will be a rolling programme to be adjusted every 3 months.
• Board authorised the Chairman to proceed with finalising a Memorandum of Understanding with the European Cancer Patient Coalition, Europa Uomo and Fight Bladder Cancer on Patient Awareness.
• Our Swedish colleagues are preparing a suggestion list of money-raising ideas for member organisations.
• Europa Uomo is sending 5 representatives to attend the Prostate17 Conference on 14-15 September being held by the EAU.
• EPAD (European Prostate Awareness Day): The Board approved the final programme for a joint event with the EAU on 27 September in the European Parliament.



News Items:
• Next year our Irish affiliate, Men Against Cancer, is marking the 25th year since its founding in 1993, with a number of events, one of which will take place in association with the GA in Dublin next year. 
 
• The Tackle AGM and Conference was held in mid-June near Birmingham in the UK.  Some 85 members attended, with representation from thirty-one support groups.  It was noted that Tackle had made considerable progress with growing the Federation, now with 87 support groups, and in its campaigning efforts, where the Tackle is more noticeable than ever before.
 
The conference had the theme of “Trials and Tribulations” and was very well received, with good feedback on the sessions.  The highlight for many was the informative and humorous session on the Management of Male Incontinence given by Julian Shah, a Consultant Urological Surgeon from UCLH and Victoria Muir, a Clinical Physiotherapist on some of the more intimate side effects many men with prostate cancer endure! 
 
Generously supported by Prostate Cancer UK (PCUK), many felt it was one of the best events in recent years. 
 
The link to Julian Shah's and Victoria Muir's presentations is below: http://www.tackleprostate.org/uploads/files/The_Management_of_Male_Incontinence.pdf  

   

IN THE PIPELINE

A Protein That Both Promotes and Prevents Prostate Cancer

Researchers at the University of Adelaide in Australia have found that Grainyhead-like protein 2, called GRHL2, plays a dual role in prostate cancer by both promoting and preventing cancer growth. It also was found to be a regulator of the androgen receptor (AR), which is essential for the development of prostate cancer.
While being key to the functioning of AR, this protein also inhibits cellular mechanisms that are necessary for prostate cancer cells to spread to other organs.
The study, “Novel androgen receptor co-regulator GRHL2 exerts both oncogenic and anti-metastatic functions in prostate cancer”, published in the Journal Cancer Research, provides new insight into the underlying mechanisms of aggressive castration-resistant prostate cancer and could lead to new treatment approaches.

Original Article: http://cancerres.aacrjournals.org/content/77/13/3417
News Report: https://prostatecancernewstoday.com/2017/07/10/prostate-cancer-regulator-of-androgen-receptor-found-in-form-of-grhl2-protein/

 

Abiraterone with ADT and Steroid Improves Survival in Castrate Resistant Prostate Cancer
A combination of androgen-deprivation therapy (ADT), abiraterone, and prednisolone is associated with improved survival among patients with locally-advanced or metastatic prostate cancer, according to the industry-funded STAMPEDE trial presented at the American Society of Clinical Oncology's annual meeting and published in the New England Journal of Medicine.

Abiraterone blocks the synthesis of androgen.  Most ADT treatments are also designed to block testosterone/androgen production, and also, preventing any unblocked androgen from getting to prostate cancer cells.  Prednisolone is a common steroid which prevents inflammation.  It is marketed under more than 2 dozen trade names.

In the STAMPEDE trial, researchers enrolled 1900 men with newly diagnosed, locally advanced or metastatic prostate cancer, or relapsed disease with high-risk features.  Patients were randomized to receive androgen deprivation therapy either with or without abiraterone acetate and prednisolone.  They were treated for up to 2 years.
Three-year survival rates were significantly higher in the combination therapy group than in the ADT group (83% vs. 76%).  There was a wider gap favouring combination therapy in terms of 3-year rates of treatment failure-free survival (75% vs. 45% for ADT alone).
http://www.nejm.org/doi/full/10.1056/NEJMoa1702900


See also report below on the LATITUDE trial with castration-sensitive men who also benefitted from this approach to the treatment of their condition.


Similar findings re Abiraterone in the LATITUDE trial for castration sensitive patients
At the same conference as the presentation of the STAMPEDE trial the LATITUDE trial results were also presented.  1200 men with metastatic, castration-sensitive prostate cancer were randomized to receive either ADT or ADT plus abiraterone acetate and prednisone.  At a median 30 months' follow-up, 3-year survival rates were higher in the abiraterone group (66% vs. 49%), and median progression-free survival was twice as long (33 vs. 15 months).  Patients taking abiraterone had higher rates of grade 3 high blood pressure (hypertension) and excess potassium in the blood.
http://www.nejm.org/doi/full/10.1056/NEJMoa1704174


Median is a term which indicates that it is the half-way point. Half or the patients had results less than the median and half were above the median.  It is not an average.

Incidence Rate of Prostate Cancer in the U.S. declines by 53% 1993-2013. Is This Good or Bad?
Prostate cancer rates in the United States are down—sharply.  According to the National Cancer Institute’s SEER program, the age-adjusted rate was 112 prostate cancer diagnoses per 100 000 men in 2013, the most recent year with available data.  This is a decline of 53% since 1992, when prostate-specific antigen (PSA) screening became widespread.
 
This decrease may be due to two factors.  Firstly, after more than 30 years of widespread PSA opportunistic screening, there are few men with high PSA levels that haven’t already been diagnosed. Secondly, and perhaps more important, PSA screening is now becoming less common.  This means that the pre-PSA untested pool has been largely used up.

In 2008, the US Preventive Services Task Force (USPSTF) advised against PSA screening for men older than 75 years.  Screening then declined in all age groups.  The 2013 prostate cancer incidence rate was the lowest since 1984, before PSA screening was used.  With the 2012 USPSTF recommendation against screening for all age groups, further reductions in incidence rates are likely although that recommendation was significantly amended earlier this year.  http://jamanetwork.com/journals/jamaoncology/article-abstract/2626511


How do lay people keep up with biomarker prostate cancer research?   
Readers may recall that in several earlier issues of Update we sought to highlight Biomarkers, Genomics and other recent developments in prostate cancer research based on molecular biology.  The wave of such material continues unabated.  One of the things which may strike the layman are the frequent similarities regarding breast and prostate cancer at a genetic level.  The classification of breast cancer tumours is now often used for prostate cancer and one of these are the sub-types luminal A and luminal B.  

A recent article in the NEJM (Prostate Cancer Molecular Subtypes: How Predictive or Prognostic?) the authors reviewed a study just published in the JAMA Oncol, May 2017 which suggests that prostate cancer patients with luminal B type tumours respond better to post-operative androgen deprivations therapy than those with non-luminal B tumours.  The investigators used a commercially available classifier (PAM50) to subtype several thousand cancer samples and with over 1500 of them they have done follow up with a median of 10 years.  The analysis of the results for prostatectomy patients and applying the classifier indicated luminal B patients benefitted from ADT whereas others did not.

In a note by the NEJM editors they state “this elegant study …provides a road map toward the validation of a biomarker to identify patients who may benefit from postoperative ADT.  In addition, it brings attention to an important, although not yet active, National Clinical Trials Network study that will use the PAM50 assay to prospectively classify patients for a trial of salvage radiotherapy with or without a next-generation antiandrogen.”

It looks like that in future we will be asking newly diagnosed patients about their luminal status as we used to about their Gleason score.   https://mail.google.com/mail/u/0/#inbox/15c5bae5a47ae424  
JAMA Oncology article:
http://jamanetwork.com/journals/jamaoncology/article-abstract/2626506

EUROPA UOMO ACTIVITIES AND NOTICES
Participants General Assembly Europa Uomo 2017, Vienna, June 9, 2017

Stunning Seminar in Vienna the Highlight of GA 17

The General Assembly took place on Friday 9th June in Strudlhof Palais in Vienna.  The GA approved the Treasurer’s and Secretary’s Reports and discharged the Board, Ekke Büchler stepped down from the Board on completion of his term and Pentti Touhimaa [Finland] was elected in his place.  The GA also gave approval to the development of a training project for patient advocates.  A fuller report will follow next week.

Ken Mastris was re-elected Chairman as were André Deschamps (Treasurer) and John Dowling (Secretary).  Will Jansen continues as one of the Vice Chairmen and Stig Lindhal replaced Ekke Büchler as the second Vice-Chairman.

The undoubted highlight of the weekend was the Patient Seminar held the following day.  In the huge Medical University, Vienna General Hospital (AKH), Ekke Büchler and Prof. Shahrokh Shariat MD put together a formidable programme which more than lived up to the Seminar Theme: 360 Degree Perspectives on Prostate Cancer.  In the forthcoming issues we hope to feature most of these presentations.  There were many attendees from Slovakia and Austria, who were able to avail of German and Slovak simultaneous translation for the seminar.

The dozen presentations from leading Austrian and other European experts not only gave up-to-date accounts of recent developments in prostate cancer diagnosis and treatments, but also provided the attendees with a fascinating insight into the likely impact of future developments in prostate cancer research and the strides being made in early diagnosis and in extending survival times for those who are unable to obtain successful curative treatment.  There were many lively question and answer sessions during the course of the day.

The event set a headline for Europa Uomo patient seminars for the future.  Congratulations again to Ekke Büchler and Prof. Shariat.

Management of Patients with Advanced Prostate Cancer
The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017
In advanced prostate cancer (APC), successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is a lack of evidence or low level of evidence.

The second Advanced Prostate Cancer Consensus Conference provided a forum for discussion and debate on current treatment options for men with advanced prostate cancer.  The aim of the conference was to bring the expertise of world experts to care givers around the world who see less patients with prostate cancer.  The conference concluded with a discussion and voting of the expert panel on predefined consensus questions, targeting areas of primary clinical relevance.  The results of these expert opinion votes are embedded in the clinical context of current treatment of men with advanced prostate cancer and provide a practical guide to clinicians to assist in the discussions with men with prostate cancer as part of a shared and multidisciplinary decision-making process.

The panel for the APCCC 2017 consisted of 61 multidisciplinary cancer physicians and scientists from 21 countries selected based on their academic track record and involvement in clinical or translational research in the field of advanced prostate cancer.
See full article in http://www.europeanurology.com/article/S0302-2838(17)30497-9/fulltext#sec0005


MRI Accuracy for Prostate Cancer Challenged
Multiparametric magnetic resonance imaging (mpMRI) often misses clinically significant prostate tumours outside index lesions, according to a study presented at a poster session MP03-13 at the American Urological Association's 2017 annual meeting. 
 
In a study including 244 prostate cancer (PCa) patients who underwent mpMRI with subsequent biopsy, Armando Stabile, MD, of Vita-Salute San Raffaele University in Milan, Italy, and colleagues found that mpMRI missed clinically significant PCa (Gleason sum of 7 or higher) outside of index lesions in 34% of cases.

When investigators stratified men according to targeted biopsy results, the detection rate of clinically significant PCa outside the index lesion was 10% and 30% of men with negative and positive targeted biopsy findings, respectively.  On multivariate analysis, PSA level, prostate volume, positive digital rectal exam, and previous negative biopsy independently predicted the overall presence of clinically significant PCa outside the index lesion.  PI-RADS, index lesion volume, and number of index lesions detected on mpMRI were not associated with overall detection of clinically significant PCa outside the index lesion. 
See full article at: https://mail.google.com/mail/u/1/#inbox/15ce85b39b81150b?projector=1
Also note Prof. Péter Nyirada’s presentation in Vienna and John Dowling’s article suggesting greater use of MRI in diagnosis.


Surveillance for Prostate Cancer Works for Younger Men
Half Avoid Intervention, No Disease-Specific Deaths at 10 Years 
Younger men with low-risk prostate cancer had outcomes with active surveillance similar to those of the general population of men who choose active surveillance (AS), according to a study reported at the 2017 Annual American Urologic Association (AUA) meeting.

AS is a safe and effective management strategy for men under 60 years of age,” Keyan Salari, MD, PhD, of Massachusetts General Hos-pital (MGH), said at the meeting. “AS spares most properly selected men from intervention and allows adequate time for intervention if it’s required. Our patients have durable metastasis-free survival and disease-specific survival, and outcomes may improve further by better patient selection with multi-parametric MRI.”

Evidence of overtreatment following the widespread use of PSA since the 1990s provided impetus for AS as an initial option for men with newly diagnosed low-risk prostate cancer.
Full article July 2017 Hot Sheet.


How a Cancer Develops - Carcinogenesis
A cancer forms when normal cells change at the cellular, genetic and epigenetic levels and become cancer cells.    The normal division of cells becomes abnormal or out of control and in some cases forms a malignant mass. 

Normal cell division is a physiological process which occurs in almost all normal tissues and this includes programmed cell death (apoptosis).  In a cancer, this cell division becomes disorderly, often more rapid, and the normal balance between cell growth or proliferation and programmed cell death gets out of balance.   All of this is called carcinogenesis. 

According to the prevailing accepted theory of carcinogenesis, the genetic and epigenetic mutations in DNA lead to cancer which disrupts the orderly cellular processes.  Only certain mutations lead to cancer, whereas the majority of mutations do not.  The body has a series of defence mechanisms which deal with most mutations.  It is those mutations which avoid these defences that tend to cause the malignant cancers.  

 

A fuller account is to be found in the article from the Belgian Journal of Medical Oncology attached to this issue.

 

 

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