Wednesday, March 30, 2011

Is Treating Prostate Cancer Really Necessary?

One of the biggest concerns on the minds of my patients is whether they actually need to get treated for prostate cancer.  Numerous studies have been mentioned in the media that demonstrate a significant overtreatment of prostate cancer.  One large study concluded that as many as 50 men might have to undergo treatment for prostate cancer to prevent one death from the disease.  These studies, although large, did have significant limitations.   As a result, we have to take these findings with a grain of salt.  Nonetheless, statistics like this do need to be taken very seriously.  Imagine if I told you that there is only a 1 in 50 chance that you actually NEED the treatment for prostate cancer that you are scheduled to receive.  Would you still be willing to take on the significant risks of these treatments?  However, when we talk about studies like this, we tend to paint everyone with the same brush.  Not all prostate cancers behave the same way.  While some move extremely slowly others can grow and spread in a short period of time.  As a result, while prostate cancer is, indeed, probably over treated today, ignoring it altogether can also lead to catastrophic results.  In this post, I will attempt to differentiate the types of prostate cancer that can and CANNOT be followed. I will also explain active surveillance, the protocol used to follow patients with a “watchful waiting” approach.  Finally, I will describe the results of studies evaluating the results of such active surveillance protocols for appropriately selected patients.

LOW RISK PROSTATE CANCER

The types of prostate cancers that are most likely over treated today are called “low risk” prostate cancers.  What makes these prostate cancers low risk?  There are actually very specific criteria:
1)      Low risk prostate cancer tends not to have a Gleason score greater than 6, making it a low to moderate grade cancer.  This grade is determined by a pathologist from a prostate biopsy depending on how the prostate cancer cells look under the microscope.  Gleason 6 prostate cancer is what I call “run of the mill” prostate cancer. It is the type that is seen most commonly in practice and is very successfully treated. 
2)      Another criteria has to do with how much cancer is found in the biopsy specimen.  Prostate cancer that is found in less than 30% of the specimens obtained and taking up no more than 50% of each specimen is considered low risk.  For example, if your urologist took 12 biopsy samples, no more than 4 samples should demonstrate cancer and no more than ½ of each sample should be taken up by cancer for your prostate cancer to be considered low risk. 
3)      Your PSA also impacts the risk of prostate cancer.  Low risk prostate cancer is associated with a PSA less than 10.  Because PSA can also be high due to large prostate size, PSA density is also used to assess risk.  PSA density is your PSA divided by the volume of your prostate (this is determined during the prostate biopsy with the ultrasound machine).  For example if your PSA is 10 and your prostate volume is 40, your PSA density is 0.25.  Studies have demonstrated that a low risk PSA density is less than 0.15.
4)      The way your prostate cancer was discovered also helps to determine the risk level.  Prostate cancers detected through an elevated PSA(stage T1c) or through a small nodule found on one side of the prostate during rectal exam(T2A) are considered low risk.

Prostate cancers that meet ALL of the above criteria are the ones that are considered to be over treated.  Studies have demonstrated that men with these low risk cancers can have their cancers monitored rather than treated without significant risk.  I will explain the results of these studies later in the post.  First, I want to describe active surveillance, the actual protocol that should be used to follow patients with low risk prostate cancer.

ACTIVE SURVEIILLANCE: THE PROTOCOL

When you and your doctor decide not to treat prostate cancer, you are not deciding to ignore it altogether.  Based on what they read on the internet, many of my patients come to me with the idea that once you forgo treatment, the prostate cancer becomes just a bad memory that you just need to put out of your mind.  In reality, nothing could be further from the truth.  Of course, there are those patients who completely ignore their prostate cancer diagnoses for years.  Unfortunately, those are the same patients that I often see some years after their initial diagnoses with painful widespread metastases and no hope of cure. 

For those men that follow a true active surveillance protocol, “active” is the critical term.  When I place a patient on an active surveillance protocol we agree to a pretty rigorous follow up regimen.  I see him back every 6 months and perform a rectal exam and a PSA test.  If the PSA goes up or the exam reveals a new, suspicious finding, we proceed with a repeat prostate biopsy.  Otherwise, if there is no change in either, we agree to repeat a prostate biopsy in 12-18 months.  After this repeat biopsy, we reassess the situation.  We see if the cancer has changed and is no longer in the low risk category.  If the cancer does not conform to all of the above criteria it cannot be considered low risk any longer.  In that situation, we again go over treatment options and, usually, the patient chooses one and proceeds with treatment.  If, on the other hand, the prostate biopsy still demonstrates low risk disease, most patients continue on the same active surveillance regimen.  The only difference with the regimen at this point is that the next prostate biopsy is usually stretched out to 18-24 months in the future.  Some patients actually switch to treatment despite the persistence of low risk disease for various reasons.  As you can see, in reality, active surveillance is a lot more involved than just looking the other way.

ACTIVE SURVEILANCE: STUDY FINDINGS

The above mentioned protocol for active surveillance did not just appear as a whim of some urologist who wanted to see his patients more often.  The regimen was actually born out of numerous studies evaluating how patients with prostate cancer did on various protocols.  Most studies to date have demonstrated that active surveillance protocols like the one mentioned above are very safe.  These studies have demonstrated that only about 25-40% switch from surveillance to treatment over a 10 year period.  That is a substantial finding as more than 50% of these patients could hold off on treatment for a decade and still feel relatively safe about their prostate cancer.  This feeling of safety comes from the fact that nearly all of the studies demonstrated that only a tiny minority of patients fall through the cracks and actually develop advanced, metastatic disease if they adhere to the protocol.  In fact, a recent study actually revealed that 5 patients died of prostate cancer out of 1800 followed with an active surveillance protocol.   Again, I cant mention enough that these studies were performed on patients with LOW RISK PROSTATE CANCER .  Protocols for patients with slightly higher risk disease are emerging but, in my opinion, are not quite ready for mainstream use…at least not if you want to sleep at night. 


TAKE HOME MESSAGE

If you don’t take home anything else from this post, I hope that you understand that the decision of whether or not to treat prostate cancer is complicated.  It is absolutely true that not ALL people need to be treated for prostate cancer.  At the same, time, however, it is also absolutely NOT true that prostate cancer is just an innocent victim with a bad reputation and that NO man with prostate cancer needs treatment.  The decision to forgo treatment and proceed with an active surveillance protocol depends on numerous factors:

  1. Healthy men should ONLY pursue active surveillance if they have low risk disease.  A new study demonstrated that if you only look at HEALTHY men, one life is saved for every 4 men undergoing treatment for prostate cancer.  A very different statistic than the 1 in 50 I mentioned above for all comers.  For men with multiple medical problems and men who are older (over 70) the requirements for active surveillance can be a little more lenient. 
  2. Men on active surveillance need to diligently adhere to a protocol over the long term.   The safety of active surveillance can only be assured if the protocol is followed and treatment is instituted if and when it is necessary. 
  3. Before pursuing active surveillance, a man really needs to know himself.  When I first diagnose my patients with prostate cancer, some of them immediately tell me that they want it out because they don’t think they would be able to live with cancer.  Others tell me that they can deal with pretty much anything if they can avoid the side effects of surgery and radiation.  A patient needs to have the right personality to be able to withstand the repeated stress of waiting for PSA and prostate biopsy results over many years. 

As we learn more and more about prostate cancer, we are beginning to see that not all prostate cancers need to be treated, at least not right away.  The decision to not treat prostate cancer can be a very good and safe one for SELECT patients in SPECIFIC situations.  However, such a path should not and cannot be generalized and applied to ALL men with prostate cancer.  As always, make sure you obtain all the important details about your prostate cancer diagnosis and discuss the options thoroughly with your doctor. The more knowledge you have, the better decisions you will make.


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5 comments:

  1. Hi PD - This is an excellent summarization of Active Surveillance (AS).

    I, particularly, like the appropriate emphasis you have placed on the decision-making process, the importance of the selectiveness of patient inclusion and the necessity of adhering to a specific, well designed monitoring protocol.

    Unfortunately, many activist patients tend to design their own protocols, often selectively ignoring important and necessary aspects of such monitoring, like the follow-up biopsies.

    I have prepared a very easy-to-read chart that clearly states the Epstein Guidelines for defining "significant" vs "insignificant" PCa, when considering AS. If you will privately furnish your E-mail address, I will happily E-mail back a .pdf copy . Dr. Epstein has already confirmed it's accuracy. I will also include a brief summary of my own professional and patient related background for your review. Best regards!- John@newPCa.org (aka) az4peaks

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  2. Thanks, doc, for another very insightful post.

    I looked at the Johns Hopkins AS guielines (discussed here: http://urology.jhu.edu/prostate/advice1.php) and they include life expectancy of < 20 years. Do you agree with that? Would you ever recommend AS to an otherwise healthy guy in his 40s or early 50s?

    Does tumor location play any role in considering whether AS is appropriate? If so, would color doppler ultrasound or MRIs be helpful in determining whether to do AS, or periodically while on AS?

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  3. I think that life expectancy should always be taken into account when dealing with prostate cancer. I always give all men the option of active surveillance but do not generally recommend to very young men unless they want to do it for a defined period of time because they may want to put off treatment for a little while. I explain to young patients that, for them, treatment for prostate cancer is usually a when and not an if.

    I dont feel that tumor location has a major role in determining whether AS is appropriate. I think that periodic prostate biopsy is much more reassuring than imaging for AS, at least for now.

    Prostate Doc

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  4. This is a great blog. I was looking for something like this and you gave me what i wanted to know.

    Prostate Cancer Treatment

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  5. I guess when the surgeon told me that "watchful waiting" (active surveillance) was not for me and my 3 and 4 Gleason and 6 out of 12 specimens cancerous, he was right.

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