FDA Approves Apalutamide for Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

The US Food and Drugs Administration has approved Apalutamide (Erleada) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The drug is now the first FDA-approved treatment in this setting.

Non-Metastatic Castrate-Resistant Prostate Cancer is where men on Androgen Deprivation Treatment experience a rising PSA but where scans do not reveal the location of a new tumour.  This new drug appears to delay the actual onset of metastases or spread for about 2 years.

The approval is based on the phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in patients with non-metastatic CRPC. The median metastasis-free survival (MFS) was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.

“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”

The company, Janssen, which obtained the FDA approval has also made an application to the European Medicines Agency for marketing authorisation for the same drug.

Read more on the following link.

http://www.onclive.com/web-exclusives/fda-approves-apalutamide-for-nonmetastatic-castrationresistant-prostate-cancer

Richard Pazdur, MD

Vienna seminar – All videos

Annual report of the board for 2016/17

It gives me great pleasure to introduce the second Annual Report for Europa Uomo which sets out,
for our members, supporters, interested parties and the health authorities, what we have done,
what we have achieved over the past twelve months and to give some indication of our future
plans, subject to the General Assembly’s direction.

Welcome speech Vienna Seminar – June 2017

 

Good morning ladies and gentlemen. Welcome to Europa Uomo’s seminar „360 Degree Prospectives on Prostate Cancer“ in Vienna,

My name is Ekkehard Büchler. I am prostate cancer surviver. I was diagnosed with a high risk prostate cancer and operated in 1993. As you can see, I am still alive.

„Selbsthilfe Prostatakrebs“ was founded by Professor Zechner, the former chief physician of the urological department at the Wilhelminen Spital in Vienna, and myself in 1997. We will celebrate 20 years Selbsthilfe Prostatakrebs this November.

Over the years our patient initiated prostate cancer education and support group has developed very well, it was a founding member of ECPC, the European Cancer Patient Coalition and of Europa Uomo – The European Prostate Cancer Coalition, where I held the position as vice chair until yesterday. Within Selbsthilfe Prostatakrebs, I will be the chairman for the next 4 years.

Our aims of our support group are as follows:

We want to offer men diagnosed with prostate cancer the possibility to talk to others in the same situation about their fears, problems, and conflicts, and to communicate their own experiences and feelings, in order to be able to help each other by understanding and learning from each other.

At workshops, meetings, we offer possibilities to listen to specialist presentations held by experts and then discuss the topics, in more detail, with the respective speakers.

Those concerned are to become „responsible and mature patients“ who are well-informed about their illness and who are empowered to help make an educated decision about which therapies are relevant and appropriate for them in consultation with their respective doctors.

What is most important for us as patients? The main questions: Will we be healed?, and what side effects will we have? What about our quality of life?

This is a question nobody in Austria can answer. And why not? A patient in Austria is diagnosed with prostate cancer and is treated in a hospital. And then he leaves the clinic with a report and is sent to his urologist. And the clinic has in most cases no, absolutely no idea how their patients are after they leave the hospital. Are they still alive or what side effects do they have?

In Sweden, for example, there is already a well-established cancer register, which is sadly missing in Austria!

The urological clinic of the MedUni Vienna has started a program called ICHOM. This is a very strict quality control of treatments. In Germany, the Martini Clinic has been using ICHOM for a couple of years and the outcome is that the Martini Clinic is now one of the leading urological clinics in the world!

But most important is an excellent relationship with our doctors! They are the ones who can save our lives.

Selbsthilfe Prostatakrebs and I are in the very lucky position of having Prof. Shahrokh Shariat as our mentor and personal friend since he is in Vienna.

In 2012 Prof. Shariat was voted best urologist oncologist in New York. He was twice selected as one of the leading urologists in the USA.

He is the only person to have been awarded both the top prizes for urology. 2014 the EAU Crystal Matula Award and now the AUA Gold Cystoscope Award just recently in Boston on May 16th 2017. He was the first person outside the USA to receive this prize.

Many top urologists from Vienna and Lower Austria are holding presentations and discussions at and with our support group.

We regret having no ways to talk and deal with our politicians. We, the prostate cancer patients and survivors have such an enormous knowledge about our problems and the politicians just do not want to know the real facts.

I hope you enjoy our seminar today. If you want to know more about prostate cancer, just join our prostate cancer education and support group. For 2017, it is just € 25.

Thank you!

Ekkehard Büchler

Download our flyer in English, German or Slovak.

Downloadable presentations:

 

Gold Cystoscope Award for Shahrokh Shariat

Shahrokh ShariatThe American Urological Association (AUA) has honoured Shahrokh Shariat, Head of MedUni Vienna’s Department of Urology, by awarding him its prestigious Gold Cystoscope Award.

In so doing, the prize jury was recognising Shariat’s contribution to urologic oncology in the areas of epigenetics, oncology biomarkers and predictive nomograms.

Shariat is the first person from outside the USA to win the prize. “It is a particular honour for me and is testament to the growing international importance of the work of our team here at the Medical University’s Department of Urology,” says Shariat, delighted at the award. “It is great that our contribution to urologic oncology is so highly valued throughout the world.”
The prize will be presented at the AUA’s annual conference in Boston (USA) on 16 May 2017.

Since 1977, the American Urological Association (AUA) has awarded the annual Gold Cystoscope Award to urologists for outstanding achievements in their field. Founded in 1902, the AUA’s mission is to ensure the highest standards in education, research and healthcare policy. It has a membership of approximately 19,000 and publishes the “Journal of Urology”.

About Shahrokh Shariat
Shahrokh Shariat came to Vienna from Teheran (Iran) as a child, completed his secondary education here and studied chemistry and mathematics at the Swiss Federal Polytechnic in Lausanne before switching to a medical course at MedUni Vienna.  After gaining his doctorate, Shariat went to the USA, where he completed a Research Fellowship at Baylor College of Medicine in Houston, Texas, and did his specialist training in urology at the University of Texas in Dallas. Shariat specialised in urologic oncology at the Memorial Sloan-Kettering Center in New York,.

From 2010 to 2013 he headed up the bladder cancer unit at Weill Medical College of Cornell University in New York.

Since June 2013 he has run the Department of Urology of MedUni Vienna at Vienna General Hospital.
Shariat has written a total of 900 peer-reviewed publications and holds four patents, which were generated from his research work in the field of prostate and bladder cancer. His Scopus h-index (Hirsch factor) is 76, his Google h-index 100. In 2012 he was voted best urologic oncologist in New York. He was twice selected as one of the leading urologists in the USA. He is the only person to have been awarded both the top prizes for urology: 2014 EAU Crystal Matula Award and now the AUA Gold Cystoscope Award 2017.

Vienna, 17 January 2017

Immunotherapy – what is it and what can it do?

In the past decade the science of genetics had expanded greatly and with the mapping of the human genome scientists have been able to understand mechanisms that tumour cells use to confuse the body’s defences and allow tumours to grow.  Clinicians have now been able to develop ways to “unmask” the cancer cells and to allow the body’s natural defences to recognise the tumour cells as foreign and shrink or eliminate the tumour.  Update will reference a series of articles about immunotherapy.  A great deal of research is taking place in the field of prostate cancer using immunotherapy techniques and there is great hope that this will prove a boon in the treatment of the disease. The following article in Cure Today may act as an introduction to the topic.

http://www.curetoday.com/publications/cure/2015/winter2015/not-immune-to-confusion-immunotherapy-to-treat-cancer?p=2 

How Ken Mastris survived prostate cancer

ken mastris prostate cancer storyAfter more than 40 years working as a credit controller with a leading British telecommunications company, Ken Mastris was greatly looking forward to retirement. With a hefty stockpile of vacation days, he decided to take some time off to travel abroad and enjoy a well-deserved holiday. While on the month-long trip, Ken started to notice some physical changes. He was not passing urine as frequently as he normally would, but chalked it up to nothing more than his body’s reaction to the hot August weather and possibly dehydration.

Read the full story (pdf)

Recommendations to lower the risk and mortality rate of the most frequent cancer in men

Prostate cancer is the most commonly diagnosed cancer in men with more than 417,000 new cases and 92,000 deaths in Europe recorded each year.

Currently, 1 in 7 men in Europe will develop detectable PCa before the age of 85. More than two million men in Europe are living with this disease.

PCa is a malignant tumour in the prostate. Most of the tumours develop slowly and do not cause any symptoms. The risk of getting PCa increases with age. PCa is in early stage generally asymptomatic, which means that there are no clear symptoms to indicate its presence. In most cases, symptoms such as trouble urinating are caused by an infection or by benign prostatic enlargement (BPE), a non-cancerous growth of the prostate. If PCa does cause symptoms it is usually a sign that the disease is at an advanced stage. The symptoms of advanced PCa include: rapid onset of local symptoms or pain in the hips, back, chest, or legs from cancer that has spread to the bones and blood in the semen.

Read full article (download PDF).

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