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Role of Active Surveillance in the Management 
of Men With Localized Prostate Cancer - artwork

NIH State-of-the-Science Conference:
Role of Active Surveillance in the
of Men With
Localized Prostate Cancer

December 5–7, 2011
Bethesda, Maryland

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Prostate cancer is the second leading cause of cancer-related deaths among men in the United States. It is estimated that in 2010, approximately 32,000 American men died of prostate cancer and 218,000 were newly diagnosed with the disease. Most prostate cancers are detected by a blood test that measures prostate-specific antigen (PSA), a tumor marker. More than half of cancers detected with PSA screening are localized (confined to the prostate), not aggressive at diagnosis, and unlikely to become life-threatening. However, 90 percent of patients receive immediate treatment for prostate cancer, such as surgery or radiation therapy. In many patients, these treatments have substantial short- and long-term side effects without any clinical benefit. Appropriate management of screen-detected, early-stage, low-risk prostate cancer is an important public health issue given the number of men affected and the risk for adverse outcomes, such as diminished sexual function and loss of urinary control.

Tools that can reliably predict which tumors are likely to progress and which are unlikely to cause problems are not available at present. Currently, clinicians rely on two observational strategies as alternatives to immediate treatment of early-stage prostate cancer: watchful waiting and active surveillance. Watchful waiting involves relatively passive patient follow-up, with palliative interventions if and when any symptoms develop. Active surveillance typically involves proactive patient follow-up in which PSA levels are closely monitored, prostate biopsies may be repeated, and eventual treatment is anticipated. Yet, it is unclear which men will most benefit from each approach and whether observational strategies will yield outcomes similar to immediate treatment when managing low-risk prostate cancer.

To better understand the benefits and risks of active surveillance and other observational management strategies for PSA-screening-detected, low-grade, localized prostate cancer, the National Institutes of Health has engaged in a rigorous assessment of the available scientific evidence. This process, sponsored by the National Cancer Institute, the Centers for Disease Control and Prevention, and the Office of Medical Applications of Research will culminate in a State-of-the-Science Conference on December 5–7, 2011, that focuses on these key questions:

A multidisciplinary planning committee developed the questions, which will be addressed in an evidence report prepared through the Agency for Healthcare Research and Quality's Evidence-based Practice Centers program. During the conference, invited experts, including the authors of the report, will present scientific evidence. Attendees will have opportunities to ask questions and provide comments during open discussion periods. After weighing the evidence, an unbiased, independent panel will prepare and present a statement addressing the key questions. The statement will be widely disseminated to practitioners, policymakers, patients, researchers, the general public, and the media.



National Cancer Institute logo         Centers for Disease Control and Prevention logo          NIH Consensus Development Program          

National Cancer Institute, NIH
Centers for Disease Control and Prevention
Office of Medical Applications of Research, NIH


Agency for Healthcare Research and Quality logo          

The Agency for Healthcare Research and Quality provided additional conference development support.



Monday, December 5, 2011

8:30 a.m.

Opening Remarks
James H. Doroshow, M.D., FACP

Division of Cancer Treatment and Diagnosis
National Cancer Institute
National Institutes of Health

8:40 a.m. Charge to the Panel
Paul M. Coates, Ph.D.

Office of Dietary Supplements
Acting Director
Office of Disease Prevention
Office of the Director
National Institutes of Health

8:50 a.m. Conference Overview and Panel Activities
Patricia A. Ganz, M.D.

Panel and Conference Chairperson
University of California, Los Angeles Schools of Medicine
   and Public Health
Division of Cancer Prevention and Control Research
Jonsson Comprehensive Cancer Center

9:00 a.m. You're Kidding....I Have Cancer? A Patient's Perspective on Coping
   With Prostate Cancer and Why “Active Surveillance” Was Not Chosen
David A. Lipton, J.D.
Securities Law Program
Catholic University of America School of Law
9:20 a.m. A Urologist's Personal Experience with Prostate Cancer
Paul F. Schellhammer, M.D., FACS
Eastern Virginia Medical School
Medical Director
Virginia Prostate Center
9:40 a.m. Cancer Diagnosis and Overdiagnosis
Gerald L. Andriole, M.D.
Robert K. Royce Distinguished Professor
Chief of Urologic Surgery
Washington University School of Medicine
Barnes-Jewish Hospital
Siteman Cancer Center
10:00 a.m. Discussion
I. How have the patient population and the natural history of prostate cancer diagnosed in the United States changed in the last 30 years?
10:30 a.m. Temporal Trends in the Epidemiology of Prostate Cancer
Otis W. Brawley, M.D.
Chief Medical Officer
American Cancer Society
10:50 a.m. Evidence-based Practice Center Presentation I: Systematic Review
    Methods and the Natural History of Prostate Cancer Diagnosed in
    the Last 30 Years
Issa Dahabreh, M.D., M.S.
Research Associate
Tufts Evidence-based Practice Center
Tufts Medical Center
11:10 a.m.

Temporal Changes in the Pathologic Assessment of Prostate Cancer
M. Scott Lucia, M.D.
Associate Professor and Director
Prostate Diagnostic Laboratory
Prostate Cancer Research Laboratories
Colorado Molecular Correlates Laboratory
University of Colorado Denver School of Medicine

11:30 a.m. Temporal Changes in the Clinical Approach to Diagnosing Prostate
    Cancer: How the Cancer of Today Differs From the Cancer of Yesterday
Ian M. Thompson, Jr., M.D.
Professor and Chair
Department of Urology
Executive Director
Cancer Therapy and Research Center
University of Texas Health Science Center at San Antonio
11:50 a.m. Discussion
12:30 p.m. Lunch
Panel Executive Session
II. How are active surveillance and other observational strategies defined?
1:30 p.m. What Is the Risk Posed by Prostate Cancer?
Peter Albertsen, M.D.
Medical Director
UConn Medical Group
Associate Dean
Clinical Research Planning and Administration
Associate Dean
Clinical Affairs
Division of Urology
University of Connecticut Health Center
1:50 p.m. Tumor and Patient Metrics, Eligibility, and Inclusion for Active
   Surveillance for Prostate Cancer
H. Ballentine Carter, M.D.
Urology and Oncology
Johns Hopkins Medicine
Division of Adult Urology
Bradley Urological Institute
The Johns Hopkins Hospital
2:10 p.m. Active Surveillance: Inclusive Approach
Laurence Klotz, M.D.
Division of Urology
Sunnybrook Health Sciences Centre
Professor of Surgery
University of Toronto
2:30 p.m. Discussion
III. What factors affect the offer of, acceptance of, and adherence to active surveillance?
3:00 p.m. Evidence-based Practice Center Presentation II: Definitions of
    Observational Strategies and the Factors That Affect the Use of
    Active Surveillance
Stanley Ip, M.D.
Associate Director
Tufts Evidence-based Practice Center
Tufts Medical Center
3:20 p.m. Presenting Treatment Options to Patients With Localized Prostate Cancer
Jenny Donovan, Ph.D.
Head of School
School of Social and Community Medicine
University of Bristol
3:40 p.m.

Improving the Communication of the Benefits and Harms of
   Treatment Strategies
Richard M. Hoffman, M.D., M.P.H.
Professor of Medicine
University of New Mexico School of Medicine
Staff Physician
New Mexico Veterans Affairs Health Care System

4:00 p.m.

Active Surveillance for Early-Stage Prostate Cancer—The University
   of California, San Francisco Experience
Peter R. Carroll, M.D., M.P.H.
Ken and Donna Derr–Chevron Distinguished Professor
Department of Urology
University of California, San Francisco (UCSF)
Associate Dean
UCSF School of Medicine
Director of Clinical Services and Strategic Planning
UCSF Helen Diller Family Comprehensive Cancer Center

4:20 p.m. Discussion
5:00 p.m. Adjournment

Tuesday, December 6, 2011

8:30 a.m. Factors Influencing Patients' Acceptance of and Adherence to Active
David Penson, M.D., M.P.H.
Professor of Urologic Surgery
Center for Surgical Quality and Outcomes Research
Institute for Medicine and Public Health
Vanderbilt University
8:50 a.m. Regional, Provider, and Economic Factors Associated With the
   Choice of Active Surveillance in the Treatment of Men With
   Localized Prostate Cancer
Ann S. Hamilton, Ph.D.
Associate Professor of Clinical Epidemiology
Department of Preventive Medicine
Division of Epidemiology
Keck School of Medicine
University of Southern California
9:10 a.m. Discussion
IV. What are the patient-experienced comparative short- and long-term health outcomes of active surveillance versus immediate treatment with curative intent for localized prostate cancer?
9:30 a.m.

Overview of Randomized Controlled Trials for Localized Prostate Cancer
Mack Roach III, M.D., FACR
Departments of Radiation Oncology and Urology
Department of Radiation Oncology
University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center

9:50 a.m. Results From the Scandinavian Prostate Cancer Group 4 Trial (SPCG-4)
Lars Holmberg, M.D., Ph.D.
Professor of Cancer Epidemiology
Division of Cancer Studies
King's College London School of Medicine
Guy’s Hospital
10:10 a.m. Results From the Prostate Cancer Intervention Versus Observation Trial
Timothy J. Wilt, M.D., M.P.H.
Professor of Medicine and Core Investigator
Minneapolis Veterans Affairs Center for Chronic Disease Outcomes
   Research and the University of Minnesota School of Medicine
10:30 a.m.

Impact of Different Management Strategies on Quality of Life in
   Localized Prostate Cancer
Mark S. Litwin, M.D., M.P.H.
Professor of Urology and Health Services
Department of Urology
David Geffen School of Medicine at the University of California,
   Los Angeles (UCLA)
UCLA School of Public Health

10:50 a.m. Economic Analysis of Different Management Strategies for Localized
   Prostate Cancer
Daniella J. Perlroth, M.D.
Research Associate
Center for Health Policy
Center for Primary Care and Outcomes Research
Stanford University
11:10 a.m. Evidence-based Practice Center Presentation III: Comparative
    Effectiveness of Active Surveillance Versus Radical Prostatectomy
    or Radiation Therapy in Men With Localized Prostate Cancer
Mei Chung, Ph.D., M.P.H.
Assistant Director
Tufts Evidence-based Practice Center
Tufts Medical Center
11:30 a.m. Discussion
12:30 p.m. Adjournment

Wednesday, December 7, 2011

9:00 a.m. Presentation of the Draft Consensus Statement
9:30 a.m. Discussion
11:00 a.m. Adjournment
Panel Meets in Executive Session
2:00 p.m. Press Telebriefing

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