Prostate Cancer Advocacy Groups Push for Clinical Trial Design Improvements to Facilitate the Development of New Treatment Options


Santa Monica, June 18, 2004 -- For the first time ever, the four major prostate cancer advocacy groups --Prostate Cancer Education Council (PCEC), National Prostate Cancer Coalition, Prostate Cancer Foundation and Us TOO International Prostate Cancer Education and Support Network -- are combining forces with the common goal of working with the U.S. Food and Drug Administration (FDA) to streamline the approval process for critical prostate cancer treatments by changing the traditional measures of a research study's success or failure, known as clinical trial endpoints, without compromising safety.

Prostate Cancer is the most common non-skin cancer in America, striking one in six men. As the baby boom men reach the target zone for prostate cancer, beginning at age 50, the annual incidence rate will increase from 230,000 to 300,000 men," stated Prostate Cancer Foundation Vice Chairman and CEO Leslie D. Michelson. "These four organizations are united in our desire to accelerate the development of better treatments for these men. Determining clinical trial endpoints that everyone can support is an important step in that process."

Traditional clinical trial endpoints, such as survival time, have proven difficult in trials of drugs for men with advanced prostate cancer because prostate cancer typically grows slowly, many prostate cancer patients typically have other diseases and prostate cancer attacks different men in different ways.

There is a growing body of evidence that surrogate endpoints, such as doubling time of Prostate Specific Antigen (PSA), changes in PSA, and time to disease progression may be useful in predicting which patients will gain true clinical benefits, such as longer survival time. At the recently convened American Society of Clinical Oncology 2004 Meeting, E. David Crawford, M.D., council member of PCEC and professor of surgery and radiation oncology with the Division of Urologic Oncology at the University of Colorado Health Sciences Center, presented a paper showing a correlation between PSA measurements and survival benefit in advanced prostate cancer patients being treated with a Taxotere regimen.

According to Dr. Crawford, "Prostate cancer has significantly lagged other cancers in the development of therapeutic options that provide patient benefit. Using straightforward measures, like PSA in conjunction with other accepted measures of anti-tumor activity and patient benefit, has the potential to simplify the clinical trial process, making trials more feasible and more attractive for sponsoring organizations. If we are going to significantly improve treatment options for men with advanced prostate cancer, we need to introduce into clinical trial design surrogate endpoints that can enable shorter, smaller trials and, thus, facilitate more rapid evaluation of new therapies for this devastating disease. We now have data from a large pivotal trial that suggest that such a marker has been identified."

Prostate cancer kills 30,000 men each year, an annual rate surpassed only by lung cancer. Advanced prostate cancer patients have extremely limited treatment options, experiencing a median survival of only 18 months.

The U.S. Food and Drug Administration (FDA) is holding a public workshop on June 21 and 22 to review current practices and formulate recommendations for optimal use of prostate cancer clinical trial endpoints. The workshop will take place on June 21 and 22 from 8:00 a.m. to 5:00 p.m. at the Bethesda Marriott, 5151 Pooks Hill Road, in Bethesda, Maryland. At the meeting, the FDA will gather expert and public testimony that will be presented to the Oncologic Drugs Advisory Committee (ODAC) and then detailed in FDA Guidance Documents, which will become the standard for clinical trial design.

"The FDA meeting and subsequent guidance will influence how much prostate cancer research gets done in the next several years," said John Page, President and CEO of Us TOO International Prostate Cancer Education and Support Network. "Hurdles for development of new prostate cancer drugs are currently very high, impeding the flow of research and new therapies. The newly reported information about improvements in survival for advanced prostate cancer patients when treated with Taxotere and FDA approval of the drug for this indication are good first steps, but these patients need and deserve additional options and even better outcomes."

"Every day, too many men are meeting their end from prostate cancer because we haven't caught up quickly enough in addressing the issue of end points," said NPCC President and CEO Richard N. Atkins, MD. "Between 1990 and 2002, 68 percent of FDA approvals for cancer drugs were made on the basis of surrogate end points, and prostate cancer patients have not yet had the same benefits afforded to others. This meeting will prove that the science is here. We must create the opportunity to save more of the nearly 30,000 lives that will be lost to prostate cancer in 2004 alone. The time is now. Let's get to work."

About the Advocacy Groups

The Prostate Cancer Education Council (PCEC) is dedicated to providing free prostate cancer screenings as well as increasing the awareness and education of the disease to men and their families. PCEC founded and coordinates the National Prostate Cancer Awareness Week Program through which more than 3 million men have been screened for prostate cancer at more than 500 screening sites across the country. Further information is available at http://www.pcaw.com.

The National Prostate Cancer Coalition (NPCC), founded in 1996, is the largest advocacy organization dedicated to ending the devastating impact of prostate cancer on men, families and society. Its goals are to increase awareness by educating the public about the disease through dynamic programs with corporate sponsors, to reach out at-risk communities by conducting free screenings for prostate cancer onboard the Drive Against Prostate Cancer mobile medical unit, and to engage citizens and associations to build an advocacy network that encourage increases in federal funding of prostate cancer research. More information is available at www.pcacoalition.org.

The Prostate Cancer Foundation is dedicated to finding better treatments and a cure for prostate cancer. Since its inception in 1993, the Prostate Cancer Foundation (PCF) has become the world's largest philanthropic source of support for prostate cancer research. The PCF has raised more than $210 million and funded more than 1,100 critical research projects in 100 research centers around the world. Further information is available at http://www.prostatecancerfoundation.org.

Us TOO International Prostate Cancer Education and Support Network is the world's oldest and largest independent, non-profit, prostate cancer education and support network, established in 1990 by five men who had each been diagnosed with and treated for prostate cancer. Since then, Us TOO has grown to more than 330 chapters throughout the United States and internationally. Us TOO and its chapters reach more than 50,000 men per month through discussion groups, lectures, publications and presentations by medical professionals. Us TOO helps men and their families learn more about prostate cancer so they can make better decisions on treatment options and cope with emotional and quality of life issues following treatment. For more information, visit the Us TOO web site at http://www.ustoo.org.