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NIH Panel Endorses Active Monitoring/Delay of Tx for Low Risk PCa

mrspjd
Posts: 688
Joined: Apr 2010

http://www.cancer.gov/newscenter/pressreleases/2011/ProstateSurveillanceStateScience

PANEL ENDORSES ACTIVE MONITORING AND DELAY OF TREATMENT FOR LOW-RISK PROSTATE CANCER, URGES FURTHER RESEARCH TO CLARIFY MANAGEMENT STRATEGIES: The National Cancer Institute at the National Institutes of Health (NIH) Press Release:

An independent panel convened this week by the National Institutes of Health has concluded that many men with localized, low-risk prostate cancer should be closely monitored, permitting treatment to be delayed until warranted by disease progression. 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.

“It’s 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.

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 later today at http://consensus.nih.gov.

The panel will hold a press telebriefing to discuss their findings today at 2 p.m. eastern time. To participate, call 888-428-7458 (inside the United States) or 201-604-5177 (International) and reference the NIH State-of-the-Science Conference. Audio playback will be available shortly after conclusion of the telebriefing and can be accessed by calling 888-632-8973 (US) or 201-499-0429 (International) and entering replay code 11996437.
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. A complete listing of the panel members and their institutional affiliations is included in the draft conference statement. Additional materials, including panel biographies, photos, and other related resources, are available at http://consensus.nih.gov/2011/prostatemedia.htm. Interviews with panel members can be arranged by contacting Elizabeth Neilson at 301-496-4999 or NeilsonE@od.nih.gov.
The conference was webcast live and will be archived shortly. Links to the archived webcast will be available at http://consensus.nih.gov/2011/prostate.htm.

Individuals interested in obtaining information about prostate cancer may wish to contact the National Cancer Institute’s 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 Prevention’s 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 panel's statement is an independent report and is not a policy statement of the NIH or the Federal Government. 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.

VascodaGama's picture
VascodaGama
Posts: 1508
Joined: Nov 2010

This is a set of standards with some controversy. Young PCa patients in the 40th cannot be accessed in the same manner as older patients in their 70th+.
Nomograms are not perfect because they include a spectrum of patients with average ages in the 65 years old. The life expectancy which is a important factor when considering AS should be estimated differently in younger (less than 50) and older (above 70) than the patients in the average age in PCa considerations.

Young men may see the postponing treatment approach as risky because they may be in their late 50th when their now advanced status requires treatment. AS recommended as a means for avoiding the risks of treatments, or just for maintaining a Quality of Life may be erroneous in young guys.

Low risk patients at diagnosis should be better informed and handled a series of unbiased and simple to understand printed official standards/questionnaires enabling and guiding them to get to a decision. These should then be reviewed by a team of professionals who would be checking the doctor's suggestions and responsible on the recommendations, equally for both; AS or early Treatment (surgery or radiation).

Thanks for posting.

Wishing the best to PJD's Family.
VGama

(note; I have edited this post)

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

Vasco,

I agree with your observations about AS for younger men. I read this report carefully and there's actually very little hard science or anything new in it. It's basically a study of studies and their objective was to reach a "consensus"...which basically means they discarded anything that they could all not agree upon.

The panel included such disparate disciplines as bioethics and humanities, health policy management, health educators, pathologists, pediatrics, insurance companies, biostatistics, and something called "society, human development, and health" out of Harvard. Given this broad spectrum of interdisciplinary backgrounds it is no wonder they came up with such a vanilla recommendation and studiously avoided addressing the more difficult question of how to address prostate cancer detection in younger men.

I also found their suggestion to redefine "cancer" for those men with PSA less than 10 and Gleason less than 7 fascinating. Reminded me of the general thrust of the PSA testing papers recently being debated (many of the same people played various roles on both boards and planning committees). I got the impression that they wanted to define prostate cancer with a PSA of less than 10 and a Gleason of less than 7 as something other than "CANCER" in order to make the men feel better. Wow. They also seek to further define surveillance protocols as either AS or WW...the AS being more aggressive and also having a bit more inherent risk.

For the typical man detected with early prostate cancer AS has been shown to have essentially the same long term survival rates as either surgical removal or conventional radiation. It's obviously too early to tell if newer forms of radiation such as SBRT will increase survival times but the more I study this I think if it does, it will probably be only a relatively modest improvement. Even when you consider that about 30% of biopsy detected tumors are upgraded after pathologic examination following surgery, the long term survival differences are within a standard deviation of one another (and not statistically significant).

In my opinion, a more rigorous approach to looking at active surveillance appears in the Journal of American Medicine Association (JAMA) titled "Active Surveillance Compared With Initial Treatment for Men With Low-Risk Prostate Cancer. (http://jama.ama-assn.org/search?fulltext=active+surveillance&submit=yes&x=11&y=8). They basically compared theoretical results from a modeling analysis between men who receive Brachytherapy, IMRT, RP, and AS and compare survival in quality of life terms. Their conclusion was that AS had about five more quality of life months than any of the other protocols at 11.02 quality of life years (QALY). RP had the worst at 10.4. To me it seems a rather moot point as Dr. Anthony Horan identified that the mean time to death from initial diagnosis of PCa was 17.5 years. For men diagnosed at 60 -65 (where most men seem to be diagnosed) the mean time to death ends up correlating pretty evenly with the overall life expectancy for Western men from any cause...so it begs the question...what cases of prostate cancer really require any treatment at all with respect to impacting long term survival?

K

rch
Posts: 78
Joined: Nov 2011

Thanks for this excellent post. I hope the NIH Panel will come to a consensus soon on at least 2 issues,first on the dx of 'low risk', and the other on the standardization of AS protocol.Under the present definition,the so called 'low risk CaP' based on PSA and Gleason score on the sextant biopsy is in the eye of the beholder. There ought to be some better diagnostic tools for risk stratification than the current ones before a young man in his 50s resort to AS based on just one 12 core bx and PSA < 10. My ambivalence about PSAs is that I know at least one case a man in his 60s who had BPH without any nodules on DRE, neg rectal US, a PSA 7.9 fluctuationg over a 5-7 yr period ,had a GS( 4+5)9 (1/12 cores), GS 6 (3/12). Thank god the Urologist hit the right spots on the 60 ml prostate.Otherwise he would have fit the definition of 'low risk'!!
Also, as you pointed out there ought to be a better AS protocol for proactive f/u. Current protocols vary widely between institutions.

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