A Call to Action to Prevent Deaths from Prostate Cancer in Europe

A coalition of influential European advocacy and professional groups are meeting today to call for action by the European Parliament to commit to serious steps to reduce the number of men affected by, and dying from prostate cancer, by ensuring timely access to information, care and support services for men at risk or with prostate cancer.

The call to action is being launched during European Urology Week, as part of a new campaign, the Proactive Prostates Initiative, at a meeting in Antwerp, which is being hosted by Europa Uomo and the European Association of Urology (EAU).

Speaking at the meeting 'Prostate Cancer: Establishing the Facts', where representatives included the European Cancer Patient Coalition (ECPC), the European Association of Urology (EAU) and Members of the European Parliament (MEPs against cancer), Prof Louis Denis of Europa Uomo said: 'We need to do more to combat prostate cancer and stop men dying or living with the burden of the disease, when so much can be done to improve awareness of earlier diagnosis and access to the right resources, services and treatments at the right time.'

Prostate cancer is the third leading cause of cancer death in European men. More than 300,000 men are diagnosed in Europe with prostate cancer every year and approximately one of five will die from the disease. These statistics are similar to breast cancer. Three-quarters of prostate cancer cases are in men over 65 years. With an increasingly ageing population, the prevalence of prostate cancer and the burden associated with this disease is set to rise.

'I urge society to sit up and take notice of prostate cancer so that we can beat this disease, yes we can", said Archbishop Desmond Tutu, the South African Nobel Peace Prize Laureate who has had prostate cancer, and fully supports the call to action.

The future for prostate cancer is not a bright one unless there is societal commitment to changing the way the disease is viewed. An increasingly ageing population means that the burdens associated with the disease will also rise, creating serious social and economic consequences.

The coalition is calling for action from society, governments, healthcare professionals and men in adopting a more proactive stance towards prostate cancer to prevent the serious burden of disease and deaths from prostate cancer.

The call to action emphasizes the need for:

• Recognition by governments of the morbidity and mortality burdens of prostate cancer, so that it can be made a higher priority in their health agenda.
• Commitment from governments to ensuring 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
• A drive to help society unite and 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.

Images courtesy American Society of Clinical oncology (ASCO)

New Molecular Test to Help Assess Prostate Cancer Risk

Gen-Probe Incorporated (San Diego, CA), a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs), announced late last week that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its PROGENSA PCA3 assay, a new molecular test that may help determine the need for a repeat prostate biopsy.

"Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PROGENSA PCA3 assay can help predict the risk of a positive follow-up biopsy, thereby improving patient care," said Eric Lai, PhD, Gen-Probe's senior vice president of research and development. "In addition, this is an important step forward in our efforts to maximize the economic value of our oncology strategy."

The clinical study of the PROGENSA PCA3 assay is expected to conclude in less than a year, after which Gen-Probe intends to submit a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration. The Company anticipates the trial will enroll approximately 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.

Data from more than 20 peer-reviewed publications suggest that the PROGENSA PCA3 assay, when used in conjunction with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as minimizing unnecessary biopsies.

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 35 will die from it. The ACS estimates that more than 192,000 Americans will be newly diagnosed with prostate cancer in 2009, and that more than 27,000 men will die from the disease.

PCA3, over-expressed in prostate cancer
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.

Gen-Probe's PROGENSA PCA3 assay, which has been CE-marked for sale in the European Union, is the first urine-based molecular diagnostic assay for prostate cancer. The test has not been approved for marketing in the United States.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November of 2003.

For more information, visit:

• Gen-Probe Inc