Drug and device development for localized prostate cancer: Report of a food and drug administration/american urological association public workshop

Jonathan P. Jarow, Ian M. Thompson, Paul G. Kluetz, John Baxley, Rajeshwari Sridhara, Peter Scardino, Peter Carroll, Peter Albertsen, H. Balentine Carter, Otis Brawley, Oliver Sartor, Howard Sandler, James J. Kiefert, Ronald A. Morton

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Summary of the discussion at a public workshop cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association reviewing potential trial designs for product and device development for the treatment of localized prostate cancer. Product development for treatment of localized prostate cancer has been stymied by the impracticality of using overall survival as an endpoint in patients with localized disease and the lack of acceptable surrogate endpoints. A workshop evaluating potential trial designs for the development of therapies for localized prostate cancer was held in San Diego, CA, in May 2013. Invited experts represented multiple stakeholders, including urology, medical oncology, radiation oncology, industry, and patient advocates. The expert panel discussed development of products for all risk strata of clinically localized prostate cancer. The panel responded to specific questions from FDA, discussing trial design for patients with low-, intermediate-, and high-risk prostate cancer, focal therapy for prostate cancer, patients who have undergone definitive radiation therapy, and adjuvant therapy for patients undergoing radiation therapy or surgery. Expert commentary provided by the panel will inform a planned FDA guidance on pathways for product and device development for treatment of localized prostate cancer and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to promote the development of new products or devices for the treatment of this disease.

Original languageEnglish (US)
Pages (from-to)975-979
Number of pages5
JournalUrology
Volume83
Issue number5
DOIs
StatePublished - May 2014

ASJC Scopus subject areas

  • Urology

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