Delay of Treatment for Low-Risk Prostate Cancer Gets Nod from NIH Panel
Recommends active monitoring but details of strategies not determined
Dec. 8, 2011 - Many men with localized, low-risk prostate cancer should be closely monitored, permitting treatment to be
delayed until warranted by disease progression, according to an independent panel convened by the National Institutes of Health.
However, monitoring strategies - such as active surveillance - have not been uniformly studied and available data do not
yet point to clear follow-up protocols. The panel recommended standardizing definitions and conducting additional studies to clarify which
monitoring strategies are most likely to optimize patient outcomes.
Its clear that many men would benefit from delaying treatment, but there is no consensus on what constitutes
observational strategies and what criteria should be used to determine when treatment might ultimately be needed among closely-monitored men,
said Dr. Patricia A. Ganz, conference panel chairperson and director of the Division of Cancer Prevention and Control Research at the Jonsson
Comprehensive Cancer Center at the University of California in Los Angeles.
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The panel's statement is an independent report and is not a policy statement of the NIH or the Federal Government.
Prostate cancer is the most common non-skin cancer in men in the United States. It is estimated that in 2011,
approximately 240,000 men will be newly diagnosed with prostate cancer and 33,000 will die of the disease.
More than half of these cancers are localized (confined to the prostate), not aggressive at diagnosis, and unlikely to
become life-threatening. However, approximately 90 percent of patients receive immediate treatment, such as surgery or radiation therapy.
For many of these patients, treatment has substantial short- and long-term side effects, such as diminished sexual
function and loss of urinary control, without clear benefits, such as improved survival. Identifying appropriate management strategies for
different subgroups of patients is critical to improving survival and reducing the burden of adverse effects.
Currently, clinicians often describe two alternatives to immediate treatment of low-risk prostate cancer: observation
with and without the intent to cure. Observation without intent to cure, sometimes referred to as watchful waiting, is a passive approach,
with treatment provided to alleviate symptoms if they develop.
Observation with intent to cure, often referred to as active surveillance, involves proactive patient follow-up in which
blood samples, digital rectal exams, and repeat prostate biopsies are conducted on a regular schedule, and curative treatment is initiated if
the cancer progresses.
The panel identified emerging consensus in the medical community on a definition for low-risk prostate cancer: a
prostate-specific antigen (PSA) level less than 10 ng/mL and a Gleason score of 6 or less.
Using this definition, the panel estimated that more than 100,000 men diagnosed with prostate cancer each year would be
candidates for active monitoring rather than immediate treatment. Importantly, however, the panel found that protocols to manage active
monitoring still vary widely, hampering the evaluation and comparison of research findings.
Prostate cancer affects some 30-40 percent of men over the age of 50. Some of these men will benefit from immediate
treatment, others will benefit from observation. We need to standardize definitions, group patients by their risks, and conduct additional
research to determine the best protocols for managing low-risk disease, stated Dr. Ganz.
The panel further recommended that disease terminology should be refined as a result of changes in the patient population
with prostate cancer due to prostate-specific antigen (PSA) testing. Because of the very favorable prognosis of PSA-detected, low-risk
prostate cancer, the panel recommended that strong consideration be given to removing the anxiety-provoking term cancer for this condition.
The panel also found that clinicians framing of disease management options is an important factor in patient
decision-making. Other influential factors include views of family members, cancer experiences of family and friends, lifestyle priorities,
and personal philosophy.
Findings from studies in communication sciences and behavioral economics could be applied in clinical settings to promote
informed, shared decision-making. While research continues to fill knowledge gaps and develop consensus, the decisions faced by men and their
providers following a diagnosis of localized, low-risk prostate cancer should be highly individualized, and include the consideration of
biological, psychological, social, and cultural factors.
With regard to future research, the panel recommended against future federal funding for single-institutional site
studies, and emphasized instead the importance of supporting multisite clinical research studies. The panel also supports the establishment of
registry-based cohort studies that collect longitudinal data on active monitoring participants, including clinical and patient-reported
outcomes.
An updated version of the panel's draft statement, which incorporates public comments received in an open conference
session this morning, will be posted at
http://consensus.nih.gov.
The state-of-the-science conference was sponsored by the NIH Office of Medical Applications of Research, the National
Cancer Institute, and the Centers for Disease Control and Prevention, along with other NIH and U.S. Department of Health and Human Services
components. This conference was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available
scientific evidence and develop objective statements on controversial medical issues.
The 14-member state-of-the-science panel included experts in the fields of cancer prevention and control, urology,
pathology, epidemiology, genetics, transplantation, bioethics, economics, health services research, shared decision-making, health
communication, and community engagement.
Individuals interested in obtaining information about prostate cancer may wish to contact the National Cancer Institutes
Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or via email at
cancergovstaff@mail.nih.gov and the Centers for Disease Control and Preventions
National Contact Center at 1-800-CDC-INFO (1-800-232-4636) or via email at
cdcinfo@cdc.gov.
In addition to the material presented at the conference by speakers and the comments of conference participants presented
during discussion periods, the panel considered pertinent research from the published literature and the results of a systematic review of the
literature.
The systematic review was prepared through the Agency for Healthcare Research and Quality Evidence-based Practice Centers
(EPC) program by The Tufts Medical Center Evidence-based Practice Center. The EPCs develop evidence reports and technology assessments based
on rigorous, comprehensive syntheses and analyses of the scientific literature, emphasizing explicit and detailed documentation of methods,
rationale, and assumptions.
A link to the evidence report on the role of active surveillance in the management of men with localized prostate cancer
is available at http://consensus.nih.gov/2011/prostate.htm.
The NIH Consensus Development Program was established in 1977 as a mechanism to judge controversial topics in medicine
and public health in an unbiased, impartial manner. NIH has conducted 123 consensus development conferences and 35 state-of-the-science
(formerly "technology assessment") conferences, addressing a wide range of issues. A backgrounder on the NIH Consensus Development Program
process is available at
http://consensus.nih.gov/backgrounder.htm.
The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27
Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of
the Director also includes program offices that are responsible for stimulating specific areas of research throughout NIH. Additional
information is available at http://www.nih.gov/icd/od.
About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department
of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research,
and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs,
visit www.nih.gov.
Keep up with the latest news for senior citizens, baby
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Dec. 8, 2011 - Many men with localized, low-risk prostate cancer should be closely monitored, permitting treatment to be
delayed until warranted by disease progression, according to an independent panel convened by the National Institutes of Health.
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CMS
also to continue expensive breast cancer drug, Avastin; Sipuleucel-T activates immune system to defend
against prostate cancer; first approved autologus cellular immunotherapy