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Though individual rare diseases (RDs) affect less than five in every 10,000 people, the aggregate number of individuals suffering from a rare disease is estimated to be nearly 400 million worldwide. The lack of efficient …

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A Vision for Action on Prostate Cancer

Submitted by on 06 Oct 2011 – 14:58

A Vision for Action on Prostate Cancer Professor Bertrand Tombal, Service d’Urologie, Cliniques universitaires Saint-Luc, Brussels, Belgium, scientific advisor to Europa Uomo

PCa is the most common cancer amongst men in Europe, with an estimated 382,000 cases occurring in 2008[1]. Almost 90,000 deaths from PCa have occurred the same year, ranking PCa the third cause of male cancer death. The incidence has risen dramatically after the introduction of PSA testing in the nineties, with disputable benefit on the mortality. One of the main hypotheses is that cancers diagnosed through organized or opportunistic screening do not contribute significantly to the lethality of the disease, while they represent a major source of over-diagnosis and over-treatment.

In 2009, a coalition of advocacy and scientific groups, coordinated by Europa Uomo, circulated a Call to Action to promote and support a comprehensive strategy ensuring that men at risk are diagnosed earlier and receive optimal treatment with holistic care on an individual basis.

This call of actions includes:

  • Recognition by governments of the morbidity and mortality burdens of PCa, so that it can be made a higher priority in their health agenda.
  • Commitment from governments to ensure sustainable support for basic research for a new biomarker and clinical research on treatment comparison.
  • Health professionals to educate their patients about the risk factors for prostate cancer, such as family history, ensuring those at risk are given appropriate information
  • Physicians to tailor treatment according to the individual patient, avoiding over- and under-treatment, through appropriate use of PSA testing to ensure that men receive the right treatment
  • Society to come together to build partnerships in helping to reduce the burden of the disease as well as identify common action and reducing the existing inequalities on access to treatment.

This “vision” can be translated into the following strategy.

Screening: Presently, “intelligent informed early detection” is mandated even more than “accurate screening”. Improving the accuracy of diagnostic tests will take many more years of research while immediate action could be taken now based on the available evidence. Opportunistic unconsented PSA testing should be censured. This must be replace by coordinated education of doctors and men about the risk factors of PCa, including race and heredity, and benefits and harms of PSA testing. In one study at least PSA testing reduced mortality. Overtreatment is not a fatality and can be tackled partially by information and education.

Regulatory frameworks: noteworthy, drug developments have been successfully conducted in PCa only in the end-of-life setting. Indeed, 8 new agents (docetaxel, zoledronic acid, abiraterone, cabazitaxel, denosumab, alpharadin, sipuleucel-T) have been registered in the last 6 years for castration-resistant PCa, an end stage disease. This comes from industry seeking rapid validation and registration. Concomitantly, there has been quasi no research on strategy for high-risk localized disease, the initial pool of patients at risk of dying from the disease. Academic research on combinatory treatment, including surgery, radiotherapy, hormonal treatment and newer molecule, is poorly supported by national and international grants, including EC frameworks programs, which focus more on basic and translational research. Most academic groups already struggling for fund raising have been slowed-down by the complexity and cost imposed by the EU regulation on human experimentation. In addition, the pharmaceutical industry has been consistently reluctant to support large trial programs outside the registration window to the detriment of the patients. Therefore any “Improved Regulatory Frameworks and Accelerated Approval Processes” must be linked with a strong engagement both from government and industry. Regulatory processes must be adapted to facilitate translation of approved drugs in an earlier setting. Industry must commit to engagement linking quicker approval to support of academic trials.

Accelerated Approval Processes also underlies regulations promoting rather than limiting clinical trials. One of the most important key actions in this regard is the centralization of high-risk patients in a “Prostate Cancer Center” who systematically embed quality control, research and reduction in routine practice. Continuous certification based on quality control and auditing must be implemented.

 

[1] Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. International journal of cancer Journal international du cancer. 2010; 127(12): 2893-917.