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.
Written by:
Jarow JP, Thompson IM, Kluetz PG, Baxley J, Sridhara R, Scardino P, Carroll P, Albertsen P, Carter HB, Brawley O, Sartor O, Sandler H, Kiefert JJ, Morton RA Jr. Are you the author?
Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, MD; Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD; Division of Biometrics V, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Department of Surgery, David H. Koch Chair, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Urology, Helen Diller Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA; University of Connecticut Health Center, Farmington, CT; Johns Hopkins School of Medicine, Baltimore, MD; American Cancer Society, Emory University, Atlanta, GA; Laborde Professor for Cancer Research, Departments of Medicine and Urology, Tulane Cancer Center, Tulane University School of Medicine, New Orleans, LA; Ronald H. Bloom Chair in Cancer Therapeutics, Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA; Board Chairman Emeritus, Us TOO, International, Des Plaines, IL; American Medical Systems, Minnetonka, MN.
Reference: Urology. 2014 Mar 22. pii: S0090-4295(14)00094-6.
doi: 10.1016/j.urology.2013.10.087
PubMed Abstract
PMID: 24661332
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