NIH State-of-the-Science Conference on the Role of Active Surveillance in the Management of Men With Localized Prostate Cancer, 40736 [2011-17307]
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Federal Register / Vol. 76, No. 132 / Monday, July 11, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
Notice.
Notice is hereby given of the National
Institutes of Health (NIH), ‘‘State-of-theScience 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 screendetected, 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
VerDate Mar<15>2010
15:30 Jul 08, 2011
Jkt 223001
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-ofthe-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 years?
2. How are active surveillance and
other observational strategies defined?
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
consensus@mail.nih.gov. The
Information Center’s mailing address is
P.O. Box 2577, Kensington, Maryland
20891. Registration and Conference
information are also available on the
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
NIH Consensus Development Program
Web site at https://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 https://
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]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cardiovascular Sciences.
Date: July 29, 2011.
Time: 2 to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Lawrence E. Boerboom,
PhD, Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814,
Bethesda, MD 20892, (301) 435–8367,
boerboom@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
E:\FR\FM\11JYN1.SGM
11JYN1
Agencies
[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Notices]
[Page 40736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17307]
[[Page 40736]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
years?
2. How are active surveillance and other observational strategies
defined?
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 consensus@mail.nih.gov. 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 https://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 https://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]
BILLING CODE 4140-01-P