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New Addition to the Prostate Cancer Roundtable Policy Agenda Addresses Quality-of-Life Endpoints
Date:12/18/2013

WASHINGTON, Dec. 18, 2013 /PRNewswire/ -- The Prostate Cancer Roundtable has updated its shared national policy agenda for 2014 to include a new policy priority, based on the idea that Phase III clinical trials of new drugs and other forms of treatment that are being tested for their ability to extend overall or progression-free survival should, at the same time, be evaluated for their impact on at least one patient-reported outcome that affects quality of life—at least as a secondary endpoint. For example, does treatment with this drug delay onset of bone pain in men with disseminated prostate cancer?

On Monday, December 9, those attending the Prostate Cancer Roundtable meeting voted unanimously to approve the suggested language and add a new section to the Policy Agenda to read:

"We seek and encourage the inclusion of quality-of-life-related endpoints, based on patient-reported outcomes data, in pivotal trials of all biologic and pharmaceutical agents being assessed for regulatory approval in the treatment of prostate cancer with a primary endpoint of improved survival—such that quality-of-life-related data (positive or negative) as well as survival data can be included in labeling for products indicated for treatment of prostate cancer as and when appropriate."

This revised policy agenda can be found at www.prostatecancerroundtable.net/agenda and serves as the group's policy priorities in discussions with legislators, media and advocates over the next year. The twelve organizations of the Prostate Cancer Roundtable represent the national organizations leading the fight against prostate cancer and speaking on behalf of the hundreds of thousands of patients diagnosed with prostate cancer each year and the estimated 2.2 million men and their families living today who have been diagnosed with the disease.

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SOURCE Prostate Cancer Roundtable
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