FDA Oncology Center of Excellence Public Workshop: Development of Treatments for Localized Prostate Cancer

Twitter: #FDAFocalTherapyPCa

U.S. Food and Drug Administration Co-Chairs:

• Julia A. Beaver, MD
• Daniel Suzman, MD
• Chana Weinstock, MD 

Date:

July 11, 2018

Time:   

8:00 am to 5:00 pm

Location:   

FDA White Oak Campus
Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
 

Background:

While several devices are approved either for treatment of localized prostate cancer or for ablation of prostate tissue, there are no drugs or biologic products currently approved for these indications. Current definitive treatment options most commonly used for localized prostate cancer include radical prostatectomy or radiation, and both are associated with both short and long-term toxicity. Development in this area is challenging given that trials with more traditional endpoints such as overall survival or even disease-free survival or metastasis-free survival in this early stage of disease would take many years to report. This workshop has therefore been designed to discuss trial designs and suitable clinical trial endpoints for treatment of localized prostate cancer in the hope of advancing effective treatment options in this area. 

No specific products will be presented or discussed.

Workshop Objectives:

• To provide a forum to discuss the development of products for the definitive treatment of patients with localized prostate cancer.
• Discuss the pros and cons of using of focal therapies for treating localized prostate cancer.
• Discuss optimal trial design and endpoints that may be used in the development of novel therapies for treating localized prostate cancer.

Webcast Information:

FDA provided a free-of-charge, live webcast of this workshop. Recordings of the webcast can be found at the following links:

• Part 1
• Part 2
• Part 3
• Part 4

Meeting Information: 

• Final Agenda and Panel Questions
• List of Speakers, Moderators and Panelists
• Issue Brief
• Transcript (not yet available)
• Presentations
  • Morning Session
    • Regulatory Considerations for Localized Prostate Cancer
      - Daniel Suzman, MD (FDA)
    • Device Regulation of Prostate Cancer Treatments
      - John Baxley, MS (FDA)
    • Focal Therapy for Prostate Cancer: The Genie is out of the Bottle
      - Jim C. Hu, MD, MPH (Weill Cornell / New York Presbyterian)
    • Focal Therapy – A Step Forward, Backwards or Both?
      - Peter R. Carroll, MD, MPH (UCSF)
  • Afternoon Session
    • Clinical Trial Design and Endpoints in the Management of Localized Prostate Cancer: Can Less be More?
      - Mack Roach III, MD (UCSF)
    • Trial Design Considerations for Low Risk Localized Prostate Cancer
      - Paul G. Kluetz, MD (FDA)
    • Statistical Considerations in Designing Clinical Trials
      - Rajeshwari Sridhara, PhD (FDA)

Contact:

Dianne Spillman
Oncology Program
Office of Hematology and Oncology Products
Office of New Drugs
Center for Drug Evaluation and Research
Dianne.Spillman@fda.hhs.gov