Watchful Waiting (Observation) Versus Surgery for Prostate Cancer





 

A new landmark study suggests that some patients with early-stage prostate cancer can be safely observed rather than undergoing radical surgery.


 

 

WATCHFUL WAITING (OBSERVATION) VERSUS SURGERY FOR PROSTATE CANCER

In the United States, prostate cancer is the most common type of non-skin cancer occurring among men, and the second most common cause of cancer death in men.  (Lung cancer, an almost completely preventable form of cancer, sadly, remains the most common cause of cancer death for both men and women.)  The American Cancer Society estimates that, in 2012, more than 240,000 new cases of prostate cancer will be diagnosed, and more than 28,000 men will die from this form of cancer.

The debate surrounding the ideal management of early-stage prostate cancer has revolved around “watchful waiting” (observation) versus aggressive treatment with surgery or radiation therapy.  In many cases, prostate cancer is a slow-growing cancer, and when it arises in older men in particular, it seldom leads to death.  On the other hand, there are more aggressive variants of prostate cancer that spread rapidly, and these forms of prostate cancer can indeed lead to death.  The dilemma regarding which patients can be safely observed and which should be subjected to aggressive treatment has been difficult to resolve, however, because it can be difficult to determine, up front, which patients will benefit from treatment and which will not.

Last year, I reviewed a prospective randomized clinical research study from Sweden which revealed a significant improvement in survival among patients with prostate cancer who underwent prostate cancer surgery, when compared to patients who were managed with “watchful waiting”  (Prostate Cancer: Watchful Waiting Versus Surgery (Prostatectomy).)  Now, a similar new prospective randomized clinical research study provides additional important clinical information that may help doctors to identify selected prostate cancer patients who can be safely observed, thus avoiding radical cancer treatments that are associated with a high incidence of incontinence and impotence, as well as other potentially serious complications.  This new study appears in the current issue of the New England Journal of Medicine, the same journal that published last year’s Swedish prostate cancer clinical research study.

In this prospective randomized study, 731 men with newly diagnosed prostate cancer were randomly assigned to undergo radical prostate cancer surgery (prostatectomy) versus observation only.  This group of research volunteers, with an average age of 67 years, was then followed for approximately 10 years, and their outcomes were carefully monitored.  It is important to note that all of these men had early-stage prostate cancer, which appeared not to have spread outside of the prostate gland.

Following 10 years of monitoring, on average, 47 percent of the men who underwent prostatectomy died, while 50 percent of the men in the observation group died (this small difference in overall survival was not statistically significant.)  When the researchers looked at the risk of death caused specifically by prostate cancer, or due to complications associated with prostatectomy, 5.8 percent of the men in the prostatectomy group died directly as a result of either their prostate cancer or due to complications of surgery, while 8.4 percent of the men in the observation group died due to their prostate cancer, for a relative cancer-specific survival difference of 37 percent and an absolute difference of 2.6 percent in favor of the men who underwent surgery instead of observation.  Importantly, however, this observed difference in cancer-specific survival did not quite achieve statistical significance, suggesting that the cancer-specific survival benefit of radical prostatectomy in men with early-stage prostate cancer is, in general, either nonexistent or very small, at least over a 10-year period of time.

Importantly, when the authors of this study assessed prostate-specific antigen (PSA) levels, specifically, as a predictor of survival among the two groups of men who participated in this study, they found that prostatectomy did, in fact, significantly improve survival among men with a PSA level greater than 10 nanograms per milliliter (ng/ml), compared to observation alone.

As is often the case, pundits on either side of the prostate cancer treatment debate will find some ammunition in this study’s findings to support their respective positions.  Those experts who espouse aggressive treatment for most or all early-stage prostate cancers will note the nearly 3 percent improvement in absolute survival associated with radical prostatectomy, although, in this study, this difference in absolute survival was not considered to be statistically significant.  (However, it should be noted that the observed survival advantage associated with surgery in this study would have actually been higher, and perhaps statistically significant as well, had there not been a postsurgical death of one of the patients in the prostatectomy group.)  On the other hand, proponents of “watchful waiting” will point to the very small difference in observed death rates between these two groups of patients, and the relatively large number of adverse events associated with radical prostatectomy (21 percent).  However, in my view, this study’s findings offer a reasonable, evidence-based, “middle ground” strategy, based upon patients’ PSA levels.  Specifically, for older patients who have a PSA level below 10 ng/ml and no worrisome microscopic features that suggest an aggressive variant of prostate cancer, observation may indeed be a reasonable alternative to prostatectomy, based upon the findings of this landmark study.  (Unfortunately, this study did not assess radiation therapy, which is the other common form of treatment for early-stage prostate cancer.)

In completing my review of this important clinical study, I should also note that 1 out of 5 patients who enrolled in this prospective study did not remain within their assigned groups and, therefore, crossed over into the opposite group after they entered into this study.  However, while this factor does somewhat complicate the analysis of the data collected in this study, it probably does not affect the overall accuracy of the study’s conclusions.

I do not believe that this important but admittedly imperfect study will, by itself, completely resolve the ongoing debate regarding the optimal management of early-stage prostate cancer.  However, as one of only a very few well-performed randomized prospective clinical studies that have directly compared radical surgery with observation alone, and with reasonable long-term follow-up of patients, this is a very important clinical research study for both patients and their prostate cancer physicians alike.  Because of this study, both patients and their doctors will now be better able to make individualized, evidence-based decisions regarding the likely risks and benefits of surgery versus careful observation as an initial approach to prostate cancer management.


At this time, more than 8 percent of Americans are unemployed.  According to the Bureau of Labor Statistics, however, the unemployment rate for veterans who served on active duty between September 2001 and December 2011 is now more than 12 percent.  A new website, Veterans in Healthcare, seeks to connect veterans with potential employers.  If you are a veteran who works in the healthcare field, or if you are an employer who is looking for physicians, advanced practice professionals, nurses, corpsmen/medics, or other healthcare professionals, then please take a look at Veterans in Healthcare. As a retired veteran of the U.S. Army, I urge you to hire a veteran whenever possible.


For a groundbreaking overview of cancer risks, and evidence-based strategies to reduce your risk of developing cancer, order your copy of my bestselling book, “A Cancer Prevention Guide for the Human Race,” from AmazonBarnes & NobleBooks-A-MillionVroman’s Bookstore, and other fine bookstores!

Within one week of publication, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books. Within three months of publication, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list.




Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


 

Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author


 

I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people from around the world who visit this premier global health information website every month.  (More than 1.3 million pages of high-quality medical research findings were served to the worldwide audience of health-conscious people who visited Weekly Health Update in 2011!)  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.


 






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New Government (USPSTF) Warning on Hormone Replacement Therapy Risks






 

A new report by a U.S. Government task force (USPSTF) recommends against the use of hormone replacement therapy due to serious health risks.



 

NEW GOVERNMENT (USPSTF) WARNING ON HORMONE REPLACEMENT THERAPY RISKS

As I discuss in my bestselling book, A Cancer Prevention Guide for the Human Race, there is now solid evidence that the most commonly used form of hormone replacement therapy (HRT) is associated with a significant increase in the risk of developing breast cancer, and that risk continues to rise with the duration of HRT use.

Like many cancer experts, I have taken issue with some of the U.S. Preventive Services Task Force’s (USPSTF) recent revisions of longstanding cancer screening recommendations, including, particularly, their 2009 recommendation that annual screening mammograms be started later in life than most experts have recommended (and continue to recommend), and performed less frequently among middle-aged women than most experts have also recommended.  More recently, in 2011, the USPSTF’s blanket recommendation that routine PSA screening for prostate cancer be largely abandoned has not been warmly embraced by me, nor by many other cancer prevention experts, given that we still cannot determine, in advance, which men with prostate cancer will be helped by treatment for this disease and which men will not benefit (and, hence, may actually even be harmed) by being treated because they have an indolent form of prostate cancer that poses no threat to their lives (Does PSA Testing for Prostate Cancer Save Lives?).

Now, the USPSTF is weighing in on another controversial cancer-related issue: hormone replacement therapy. Prior to 2002, more than half of all American women took some form of HRT to treat the common symptoms of menopause, including hot flashes, night sweats, vaginal dryness, and irritability.  As I discuss in my forthcoming book on the tragic history of HRT, The Manufactured Myths of Menopause and Hormone Replacement Therapy: A Legacy of Suffering and Death, the intentionally deceptive multi-decade marketing of HRT drugs as a panacea for the both the real and imagined consequences of menopause, and the skillful (if duplicitous) portrayal of menopause as a pathological disease that renders its “victims” something less than feminine, was only recently revealed to be a collection of gross distortions (to put it mildly) on the part of the dominant manufacturer of HRT medications.  Thanks to the landmark findings of the enormous Women’s Health Initiative study, which was published in the Journal of the American Medical Association in 2002, we now know that long-term HRT use is clearly associated with an increased risk of multiple and serious health problems, including an increased risk of breast cancer.

The USPSTF is now about to weigh-in on the issue of HRT, in a paper that is to be released in the June 4th issue of the Annals of Internal Medicine.  Unlike their other recent controversial pronouncements, however, I actually find the USPSTF’s new recommendations against the routine use of HRT to be very close to my own recommendations, and so I am including their review of the existing clinical research data on HRT in this column.

After comprehensively reviewing the data from 9 different prospective, randomized, placebo-controlled, blinded clinical studies (including the massive Women’s Health Initiative study), the USPSTF study group determined that both estrogen-progesterone (combination) HRT and estrogen-only HRT significantly increased the risk of stroke, potentially fatal blood clots (venous thromboembolic disease), gallstones, and urinary incontinence.  Estrogen-progesterone (combination) HRT was also, once again, shown to be associated with a significantly increased risk of breast cancer, as well as a probable increase in the risk of dementia.  (On the other hand, estrogen-only HRT, which can only be taken by women who have previously undergone hysterectomy, appears to actually decrease the risk of developing breast cancer, while both types of HRT also appear to reduce the risk of osteoporosis-associated bone fractures.)

Based upon the increasingly large amount of available clinical research data, HRT, of any type, cannot currently be recommended for routine long-term use, given the multiple and significant health risks associated with both estrogen-only and estrogen-progesterone forms of HRT.  After decades of intentionally misleading advertising by the manufacturer of the two most frequently prescribed forms of HRT, and the manufacturer’s intentional co-opting of numerous women’s physicians over the years, the true risks associated with the long-term use of HRT have now become abundantly clear.  I will have much more to say about this cautionary tale when The Manufactured Myths of Menopause and Hormone Replacement Therapy: A Legacy of Suffering and Death is published in early 2013….


For a groundbreaking overview of cancer risks, and evidence-based strategies to reduce your risk of developing cancer, order your copy of my bestselling book, “A Cancer Prevention Guide for the Human Race,” from AmazonBarnes & NobleBooks-A-MillionVroman’s Bookstore, and other fine bookstores!

Within one week of publication, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books. Within three months of publication, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list.




Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


 

Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author


 

I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people from around the world who visit this premier global health information website every month.  (More than 1.3 million pages of high-quality medical research findings were served to the worldwide audience of health-conscious people who visited Weekly Health Update in 2011!)  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.


 







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Prostate Cancer and High Intensity Focused Ultrasound (HIFU)

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“A critical weekly review of important new research findings for health-conscious readers”


PROSTATE CANCER AND HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)

The two most commonly used treatments for early-stage prostate cancer, surgery and radiation therapy, are both associated with a significant risk of potential complications, including impotence and varying degrees of urinary incontinence.  Because of these serious side effects of prostate cancer therapy, new approaches to the management of this common type of cancer are constantly being evaluated.

High intensity focused ultrasound (HIFU) is a relatively new and non-invasive approach to cancer therapy.  Unlike more invasive cancer treatments, HIFU focuses very powerful ultrasound (sound wave) beams directly at a tumor.  These focused ultrasound beams then cause the tumor to become heated to the point that the tumor is killed.  Unlike radiation therapy, however, which is used to essentially destroy the entire prostate gland (or surgery, which requires the removal of the entire prostate gland), HIFU can be focused onto just the portion of the prostate gland where early-stage tumors are located.

A newly published research study, which appears in the current issue of the Journal of Urology, has evaluated the use of HIFU in carefully selected patients with very early prostate cancer.  In this small prospective clinical research study, 20 men with small, localized prostate cancer tumors were treated with HIFU.  Repeat biopsies of the prostate gland were then performed 6 months later, and these 20 men were then reassessed, once again, 12 months after undergoing HIFU treatment of their early prostate cancers.  (Low-risk cancers were present in 25 percent of these men, and intermediate-risk prostate cancers were present in the remaining 75 percent of these male volunteers.)

At 12 months following HIFU therapy, an amazing 95 percent of these men were still sexually potent.  Moreover, 90 percent of the men had complete control of their urinary stream (urinary continence), and 95 percent of these men did not require a protective pad in their underwear to prevent soiling of their clothes with urine.  Moreover, 89 percent of these men were simultaneously free of urinary leaks, impotence, and detectable recurrences of their prostate gland tumors at 12 months. (These extremely impressive results with HIFU reveal a complication rate that is far below what has been described for surgical removal of the prostate, and for radiation therapy for prostate cancer; as well as an excellent cancer control rate at 12 months.)

Now, a few caveats before anyone gets too excited about the results of this study.  First of all, this was a very small study, and the patients who participated in this study were very carefully selected based upon the very small size of their prostate cancer tumors.  Secondly, prostate cancer is, in general, a slow-growing cancer, and the 12-month period of follow-up of these study volunteers is much too brief to measure the long-term effectiveness of HIFU for the treatment of prostate cancer.  Finally, although HIFU is considered a non-invasive form of treatment, it generates very high temperatures within the tissues that are targeted by the ultrasound beams.  As with radiation therapy, HIFU can, therefore, also cause unintended damage to surrounding organs, and can cause some of the very same complications associated with radiation therapy.

While not yet ready for “prime time,” HIFU may still have an important future role in the management of localized prostate cancer.  However, in my view, larger clinical studies, and longer patient follow-up, will be necessary before HIFU proves itself to be equal to surgery and radiation therapy in the management of prostate cancer.

 

For a complete evidence-based discussion regarding an evidence-based cancer prevention lifestyle, order your copy of my new book, A Cancer Prevention Guide for the Human Race.  For the price of a cheeseburger, fries, and a shake, you can purchase this landmark new book, in both paperback and e-book formats, and begin living an evidence-based cancer prevention lifestyle today!



On Thanksgiving Day, 2010, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books! On Christmas Day, 2010, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list!


Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity



Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link:

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I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people, from around the world, who visit this premier global health information website every month. (More than 1.2 million health-conscious people visited Weekly Health Update in 2010!) As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.





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