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 journalArticle

7 Citations (Scopus)

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)975-978
Number of pages4
JournalUrology
Volume83
Issue number5
DOIs
StatePublished - 2014

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United States Food and Drug Administration
Prostatic Neoplasms
Education
Equipment and Supplies
Pharmaceutical Preparations
Therapeutics
Radiotherapy
Pharmacy and Therapeutics Committee
Equipment Design
Radiation Oncology
Medical Oncology
Urology
Advisory Committees
Industry
Biomarkers
Survival

ASJC Scopus subject areas

  • Urology

Cite this

Drug and device development for localized prostate cancer : Report of a food and drug administration/american urological association public workshop. / Jarow, Jonathan P.; Thompson, Ian M.; Kluetz, Paul G.; Baxley, John; Sridhara, Rajeshwari; Scardino, Peter; Carroll, Peter; Albertsen, Peter; Carter, H. Balentine; Brawley, Otis; Sartor, Oliver; Sandler, Howard; Kiefert, James J.; Morton, Ronald A.

In: Urology, Vol. 83, No. 5, 2014, p. 975-978.

Research output: Contribution to journalArticle

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 2014, 'Drug and device development for localized prostate cancer: Report of a food and drug administration/american urological association public workshop', Urology, vol. 83, no. 5, pp. 975-978. https://doi.org/10.1016/j.urology.2013.10.087
Jarow, Jonathan P. ; Thompson, Ian M. ; Kluetz, Paul G. ; Baxley, John ; Sridhara, Rajeshwari ; Scardino, Peter ; Carroll, Peter ; Albertsen, Peter ; Carter, H. Balentine ; Brawley, Otis ; Sartor, Oliver ; Sandler, Howard ; Kiefert, James J. ; Morton, Ronald A. / Drug and device development for localized prostate cancer : Report of a food and drug administration/american urological association public workshop. In: Urology. 2014 ; Vol. 83, No. 5. pp. 975-978.
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