[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Page 40736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17307]

[[Page 40736]]



National Institutes of Health

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

ACTION: Notice.


    Notice is hereby given of the National Institutes of Health (NIH), 
``State-of-the-Science Conference on the Role of Active Surveillance in 
the Management of Men With Localized Prostate Cancer,'' to be held 
December 5-7, 2011, in the NIH Natcher Conference Center, 45 Center 
Drive, Bethesda, Maryland 20892. The Conference will begin at 8:30 a.m. 
on December 5 and 6, and at 9 a.m. on December 7, and will be open to 
the public.
    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 NIH 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 NIH Office of Medical 
Applications of Research will culminate in a State-of-the-Science 
Conference December 5-7, 2011, that focuses on these key questions:
    1. How have the patient population and the natural history of 
prostate cancer diagnosed in the United States changed in the last 30 
    2. How are active surveillance and other observational strategies 
    3. What factors affect the offer of, acceptance of, and adherence 
to active surveillance?
    4. 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?
    5. What are the research needs regarding active surveillance (or 
watchful waiting) in localized prostate cancer?
    These questions, developed by a multidisciplinary planning 
committee, 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.

FOR FURTHER INFORMATION CONTACT: Advance information about the 
Conference and Conference registration materials may be obtained from 
the NIH Consensus Development Program Information Center by calling 
888-644-2667, or by sending e-mail to [email protected]. The 
Information Center's mailing address is P.O. Box 2577, Kensington, 
Maryland 20891. Registration and Conference information are also 
available on the NIH Consensus Development Program Web site at http://consensus.nih.gov.

    Please Note:  As part of measures to ensure the safety of NIH 
employees and property, all visitors must be prepared to show a 
photo ID upon request. Visitors may be required to pass through a 
metal detector and have bags, backpacks, or purses inspected or x-
rayed as they enter NIH buildings. For more information about the 
new security measures at NIH, please visit the Web site at http://www.nih.gov/about/visitorsecurity.htm.

    Dated: July 1, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-17307 Filed 7-8-11; 8:45 am]