title: Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.
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.
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, MD. Electronic address: Jonathan.jarow@fda.hhs.gov.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
authors.affiliation: Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Thompson
authors.affiliation: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, MD.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Kluetz
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD.
authors.forename: John
authors.initials: J
authors.lastname: Baxley
authors.affiliation: Division of Biometrics V, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD.
authors.forename: Rajeshwari
authors.initials: R
authors.lastname: Sridhara
authors.affiliation: Department of Surgery, David H. Koch Chair, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Peter
authors.initials: P
authors.lastname: Scardino
authors.affiliation: Department of Urology, Helen Diller Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.
authors.forename: Peter
authors.initials: P
authors.lastname: Carroll
authors.affiliation: University of Connecticut Health Center, Farmington, CT.
authors.forename: Peter
authors.initials: P
authors.lastname: Albertsen
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, MD.
authors.forename: H Balentine
authors.initials: HB
authors.lastname: Carter
authors.affiliation: American Cancer Society, Emory University, Atlanta, GA.
authors.forename: Otis
authors.initials: O
authors.lastname: Brawley
authors.affiliation: Laborde Professor for Cancer Research, Departments of Medicine and Urology, Tulane Cancer Center, Tulane University School of Medicine, New Orleans, LA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.affiliation: Ronald H. Bloom Chair in Cancer Therapeutics, Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA.
authors.forename: Howard
authors.initials: H
authors.lastname: Sandler
authors.affiliation: Board Chairman Emeritus, Us TOO, International, Des Plaines, IL.
authors.forename: James J
authors.initials: JJ
authors.lastname: Kiefert
authors.affiliation: American Medical Systems, Minnetonka, MN.
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Morton
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D004864:Equipment and Supplies; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D011471:Prostatic Neoplasms / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents