Yet another non scientific study on Prostate Cancer

Jan 31st 2013, NEJM publishes a "story" regarding Prostate Cancer treatment and complications. The article immediately concludes that most men have potency issues 15 years after either surgery to remove the Prostate or radiation. By their own admission, the study did not compare impotency rates against a control group but did point out the average age at the 15 year point was 89! I think the article should gave congratulated the 15% of men at 89 that were still sexually active!

The articles conclusion was we should really consider this when determining if treatment is appropriate.

Prostate cancer death can be extremely painful, it normally metastasizes to the bone, the side effects of treatment (In My Humble Opinion) are insignificant compared to the painful symptoms of metastatic Prostate cancer.

The System Sometimes Works - Why a baseline PSA is important.

Here's a success story and for once i'm impressed, not only did the system work, it worked when by all rights this patient would normally have slipped through the cracks and the results probably would have ultimately proven to be fatal.

This is the main reason men should have a baseline PSA performed in their 40's.

A 53 year old patient presented with a PSA of 1.1 but has a palpable nodule in his prostate, that has been biopsied and is confirmed to be cancer.

The patient has a family history of prostate cancer, his father died from metastatic prostate cancer. His primary care physician had been performing routine (annual) PSA screenings. I'm not sure what prompted the primary care physician to follow up but this man had three good reasons for follow-up:

1. Family history, his father died from prostate cancer.
2. Rising PSA.
3. An abnormal DRE.

Normally if a 53 year old male has a PSA of 1.1, it could/would be considered normal. Most physicians still use the magic number of a PSA of 4.0 as an action level to follow-up. Even the more recent recommendations is 2.5 for men under 70 (and that's for those that even still agree to do screening PSA's).  In this man's case his PSA actually went from:

Date                PSA
Sep-08             0.6
May-09            0.6
Nov-09            0.7
Nov-10            1.4

The primary care physician repeated the PSA in May 2012 and it had dropped to 1.1 (I left it out of the graph because it confuses it) but the primary care physician performed a DRE. It indicated this was not a bad reading I personally think one should have been performed within 3 months of the first abnormal reading but... low and behold they felt a firm nodule on the prostate. The patient was referred to the Urologist who decided to perform a biopsy. Of the six cores removed, one of them was positive for Adenocarcinoma with a Gleason score of 6 (3 + 3) in 10% of the sample.

This could have gone bad at so many junctures. What if;

1. If the physician looked at the PSA only and said, 1.4 is normal, not an unreasonable decision even for  53 year old..
2. If the nodule was on part of the prostate that was not within reach of the finger.
3. If the primary care physician was not experienced enough to recognize the nodule was not normal.
4. If the biopsy had missed the tumor (it's still possible some of the other cores did miss other tumors).

Bottom line, you need to look at the whole picture. Even if the nodule(s) weren't palpable, the PSA velocity indicates there is something bad going on here. The doubling time was 1 year. Having 3 years of constant readings followed by 2 indicating an increase is a big red flag. This patient needs treatment, he is 53, the chances are good that if left untreated, the cancer will cause his demise.


GOOD WORK to all those involved.

Get a baseline PSA performed! Then annual screening (every two years might be acceptable if your young and have no family history or other contributing factors).

PSA Testing, I'm getting more annoyed

The more I read the USPSTF recommendations on Prostate Cancer Screening the more annoyed I get. Part of their recommendations are what "practitioners" should tell their patients. The article "Talking With Your Patients About Screening For Prostate Cancer" is for doctors and suggesting to them on how they should deal with their patients, even ones that ask about screening. I really hope there aren't any doctors that actually follow the recommendations in the document!

If you read my previous blog, you'll know I'm "flogging a dead horse" but the recommendation specifically looks at whether screening is a tool to prevent deaths. It ignores quality of life. It also assumes that a high reading that results in a negative biopsy is a false positive and results in unnecessary treatments. I'm not saying there aren't men being unnecessarily treated but I don't think it's as widespread as men that are being screened, detected and appropriately treated.

These articles quotes statistics for some things and uses vague terms or others, for example;

• 90 percent of men with prostate cancer found by PSA choose to receive treatment. Many of these men cannot benefit from treatment because their cancer will not grow or cause health problems. 

How many constitutes many? Merriam-Webster dictionary defines many as:

• consisting of or amounting to a large but indefinite number

I could not disagree with this statement any more. I'm yet to meet a cancer that does not grow and cause problems, unless of course you dies before it grows. Again referring to Merriam-Webster dictionary on the definition of cancer;

• a malignant tumor of potentially unlimited growth that expands locally by invasion and systemically by metastasis.

Here's what should happen (in my opinion), and I'm assuming the worst case here.

1. You get a PSA test with a high reading (high being a relative term).
2. Repeat the PSA. If it's higher still, repeat it one more time
3. You go to your urologist, he'll decide if it's an Infection, BPH, or needs a biopsy.
4. You get a biopsy.
5. You wait a week, it comes back negative, no cancer found!

Great, I'm done. Well not yet. You need to wait 3 months and get another one. If it continues to rise you need to go back for another biopsy, it's quite possible they just missed the tumor (I will write an article on this soon), especially if the prostate cancer is early and small.

I've seen/heard of patients that have gone back 4-5 times before they finally found the cancer, his PSA kept rising though. By the time they biopsied a piece of cancerous tissue his PSA was in the 20+ range.

Use common sense, if your 90 and have heart problems your probably not going to look for a prostate cancer. If your 60 and in great health get a PSA test, in fact if you haven't had one performed earlier as a baseline, shame on you!

I'd really like to know if all the people on this task force follow these recommendations for themselves of their family members. I sure hope they don't and won't.

USPSTF Position on PSA Testing, a D?

Well obviously they did not read my last blog, I guess I really didn't expect them to! I need to Blog more frequently so it can be read and make it higher on peoples list and maybe they'll see it. I don't think it will affect their decision though.

The US Preventive Services Task Force (USPSTF) published their current recommendations on PSA screening. They gave it a "D" that means "The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits." So their recommendations for practice is "Discourage the use of this service."

The Draft recommendation last October recommended that man over the age of 75 not be tested, but testing for men under the age of 75 the data was inconclusive. The final recommendation is much more damaging.

This study was generated from two main sets of data. The first is considered to as the US PLCO trial, This is the prostate, lung, colorectal and ovarian cancer trial data all rolled into one. The second is the RESPC trial from Europe, which is the European Standard Study for Screening of Prostate Cancer. The bottom line is this data specifically looks at mortality, that is how many men die from Prostate cancer. The conclusion they say from the data is 4-5 per 1000 men. According to the research quoted as part of this study, if we screen all men with a PSA Test that only decreases the number of deaths from prostate cancer by 1? If you're that one man out of every 1000, that's pretty significant. It could also mean that most men, even if they have prostate cancer, are dying from some other cause or they're list cause of death os something other than prostate cancer. Men do not typically die from prostate cancer, they might die from the complications of prostate cancer and it really depends on how that is listed on the death certificate. This relates back to how accurate the statistics are in the above mentioned studies. This is a subject of a whole different blog.

"There are three kinds of lies: lies, damned lies and statistics."

- Mark Twain's Own Autobiography: The Chapters from the North American Review

Last year (2011) at a UK meeting, data was presented that showed that the death rate for men diagnosed with Prostate Cancer in the UK was almost 50% compared with 15% in the US. They attributed the large disparity to the fact that PSA screenings are not performed for asymptomatic men the UK. So their conclusions were the exact opposite.

But let's continue, let's assume their statistics are right:

To me the issue is what about quality of life? This study implies it is concerned about quality of life because it discusses the complications of the biopsy and treatment. What about the complications of not being treated? If you have an aggressive prostate cancer you will get worse complications from the disease than the treatment. It's like everything else in life, it's a risk vs benefit relationship. BUT you cannot adequate evaluate the risks and benefits if you don't have the appropriate information. The PSA test gives you an important piece of that information.

Without a PSA Test, by definition, prostate cancer cannot be found until it is at last grade of Stage 2, referred to as a T2B, almost a Stage 3. It has to be palpable (felt).

Stage	Tumor	Nodes	Metastasis	Grade
Stage I	T1a	N0	M0	G1
Stage II	T1a	N0	M0	G2–4
	T1b	N0	M0	Any G
	T1c	N0	M0	Any G
	T1	N0	M0	Any G
	T2	N0	M0	Any G
Stage III	T3	N0	M0	Any G
Stage IV	T4	N0	M0	Any G
	Any T	N1	M0	Any G
	Any T	Any N	M1	Any G

The BEST case scenario, according to the Partin tables, data widely accepted to be the best authority on whether the cancer has spread outside the prostate gland) is that 12% of men already have disease outside the prostate. If you have a palpable prostate and a biopsy shows a PSA of over 4, that jumps to 29%. A lot of doctors won't even send you for a biopsy until the PSA is over 4. That means 3 out of 10 men that have a PSA over 4 and a palpable nodule will have disease outside their prostate ALREADY.

I want to get tested (and do). If it comes back high I can then decided if I want to take the risk of the biopsy, and if subsequently it's cancer, I can decide if I want to take the risks of my chosen treatment. If I wait until I am symptomatic my options have immediately decreased as will my potential life span if I'm otherwise healthy. Metastatic prostate cancer is a horrible disease, but we can control localized prostate cancer.

Have your PSA tested, then you can make an informed decision. It's a cheap test. If you can't afford it, contact a local Prostate Cancer Awareness Group of which there are thousands, some of them offer free screenings.

U.S. Preventive Services Task Force recommendations of PSA screening for Prostate Cancer

How many of you read the following types of news article earlier this year?

U.S. Panel Says No to Prostate Screening for Healthy Men

NY Times, By GARDINER HARRIS, Published: October 6, 2011

Or this one,

PSA test for prostate cancer not recommended: panel

Reuters, By Julie Steenhuysen, CHICAGO | Fri Oct 7, 2011 6:19pm EDT

I know a lot of my patients did and I’m disgusted.  The articles made statements such as;

“The U.S. Preventive Services Task Force, which advises the government on health prevention measures, on Friday downgraded its recommendation on prostate cancer screening to a "D," which means it recommends against the service because "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits”

and

“Healthy men should no longer receive a P.S.A. blood test to screen for prostate cancer because the test does not save lives over all and often leads to more tests and treatments that needlessly cause pain, impotence and incontinence in many, a key government health panel has decided.”

Where do I start. As seems to be all so common with the mainstream media, they left out a few important facts from the recommendation from the USPSTF. It make for much more sensationalist articles. The grade’s came from the 2008 article. The newer 2011 article made no such recommendations. This newer article just stated that “Prostate-specific antigen–based screening results in small or no reduction in prostate cancer–specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary.”

Let’s evaluate the 2008 recommendations, the first of which is;

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years.

Let me paraphrase here, in men younger than 75 years old the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening

The second recommendation was: 

The USPSTF recommends against screening for prostate cancer in men age 75 years or older.

Let’s deal with the second recommendation first. If you are 75 years old and are diagnosed with Prostate cancer there is a pretty good chance you are going to die of something else. This statement is statistically true, but I personally do not want to be treated as a statistic. Simply this means mean more than half of the people will die of something else. Maybe even 90%. But what if you are one of the men that won’t. Prostate cancer typically metastasizes to bone which can be very painful. Without diagnosis and treatment it’s can be a miserable death.

I personally think we need to be more intelligent with our evaluations. For example if we have two 75 year old patients;

• ·      Patient A is diagnosed with prostate cancer with a PSA of 5000 and a Gleason Score of 4+5=9.
• ·      Patient B has a PSA of 1.5 and Gleason is 3+3=6.

So in this case I would not recommend treatment for Patient B, I would repeat the PSA in 3-6 months and see how fast it’s progressing.

Patient A could benefit from local control of the prostate cancer, external beam Radiation treatment, then treatment of the any painful bone metastases.

Let’s confuse the issue, there is a third patient that has a PSA of 2.2 and a Gleason score of 4+5. He needs treatment.

Now back to the first recommendation, if you’re less than 75 years old then the data is insufficient. The USPSTF was comparing the validity of the PSA test. This is a subject that I will address in detail at a later date but it is my belief that the PSA test, although not perfect, is still currently the best test available. The report went on to say 12-13% of the PSA’s are falsely positive (we call it a false positive when a PSA test it considered positive due to it’s high value but is “proven” to be incorrect). Assuming this is true (again, I’ll address this issue later too), how do you prove it’s false. Normally the doctor will perform a Digital Rectal Exam (DRE) at the same time, this is used as secondary check (see link for more information). The more definitive test is a prostate biopsy. If the biopsy comes back negative then it’s assumed a false positive. I contend that, and I admit I have little proof other than my clinical experience, that 90% of these are bad or incorrect biopsy’s.

The newer report states that there is “no reduction in prostate cancer–specific mortality”. Assume that is true, that’s not the point, what about quality of life, would you rather die instantly of a massive stroke or heart attack or would you rather suffer with a painful debilitating disease eventually to succumb to the disease. I personally believe that early detection does increase life, the problem is when you dies and are known to have cancer, the doctor writes cancer on the death certificate. Less than 5% of people that die in a hospital ever get an autopsy. (this is the subject of a whole new blog).

The biggest problem I have with all this is in order to find out if you have an treatable form of prostate cancer you need to find it first. The best way is the PSA test. Does it have issues, yes, but the bigger issues are not the PSA test itself, but the biopsy and complications of treatment. The bottom line for most of our patients, is:

• ·      Sure I don’t want erectile dysfunction, but I’d rather be alive.
• ·      Sure I don’t want urinary incontinence, but I’d rather be alive.
• ·      Sure I don’t want a rectal fistula, but I’d rather be alive.

So again, should you get a PSA screening, my answer is unequivocally, YES!

PSA testing

There have been a number of articles on the validity of the PSA test. Last Year, a Dr. Gifford Jones, a gynecologist practicing in Toronto, wrote an article published on the web site www.CanadaFreePress.com titled “Seven Things to Know About Prostate Cancer”. What makes a gynecologist an expert on a make urologic issue, I’m not sure, but that surely allows me, as a board certified medical specialist, to respond.

One. 

First of all, it was not Disraeli, who remarked, “there are three kinds of lies, lies, damn lies and statistics”, it is actually popularized by Mark Twain. No evidence of the quote can be found in any of Disraeli’s works and the first known appearance of this saying appeared years after Disraeli’s death. In this article Dr. Jones referenced an article from the New England Journal of Medicine that had just reported a European study that showed that this blood test cut the death rate of this disease by 20 percent. But then goes on to editorialize “But this impressive figure refers to a relative reduction in deaths” (Emphasis added). He continues on to quote figures that of those that received the PSA test, 261 died, compared to the 383 who received routine care. He then states; “A difference of 102 deaths out of 162,000 men isn’t as impressive”. I beg to differ, especially if your one of the 102 patients or a family member of one of those who didn’t die! The next paragraph is even more egregious, it states as a result of the PSA test 1,410 men have to be screened (by the PSA test), from that 48 of these men are treated, to prevent one prostate cancer death. The implication here is if you test 1,410 men, this will result in an additional 48 men being diagnosed with and treated for prostate cancer but 47 of those men will still be cured of their disease. That seems like you are saving the lives of 47 men out of every 1,410 who are tested. Now who’s playing with numbers? There are numerous problems here. First if all, if a patient has advanced cancer and dies, normally the cause of death listed on the certificate of death as cancer. Rarely does cancer kill the patient, it is normally complications of that cancer or the treatments used to keep them comfortable that kills them. Ultimately all of us die of cardiac arrest.


Two

Dr. Jones’ treatment information is questionable at best. Radium seeds have NEVER been used for prostate cancer, the choices are Iodine, or Palladium and more recently Cesium has been introduced. Current protocols call for Radical Prostatectomy, External Beam Radiation or Radioactive Seeds, and/or Hormone therapy are the three primary treatment modalities. It is reasonable well understood by most physicians, which treatments are the most appropriate depending on the age of the patient and the diagnostic indicators. There are “newer” therapies, Cryosurgery, Hyperthermia, etc, etc, but the three above mentioned are still considered the primary options.


Three

This is where Dr. Jones and I sort of agree. Marilyn Von Savant was once asked, is medicine an art or a science? Her response was “it was a science performed by artists”. Like most things, as long as humans are involved there is always some variability, in this case it is in determining how malignant the tumor is. But Dr. Gleason developed a method of grading the “aggressiveness” of prostate cancer. It has become a reliable indicator of aggressiveness of the disease and is used (along with the PSA) a one of the primary diagnostic indicators in determining which form of treatment is the most appropriate. Ironically, the late Dr. Whitmore, “a world authority on prostate cancer” allegedly died from metastatic prostate cancer. When a colleague of my partner asked what him what his PSA was, he responded, he didn’t believe in the PSA test!

Four

“First, do no harm”. When you inject a patient, you do harm, it must, every young child cries when receiving a shot. Medicine should be looked at as a cost vs. benefit approach (when I say cost I don’t mean financial, although that seems to be entering into it more and more).


Five

The one question left out of all these responses is quality of life. I’ve watched many men get worse and worse due to the progression of their prostate cancer eventually succumbing to it. When prostate cancer advances it spreads to local organs which are the bladder and colon/rectum, eventually metastasizing to the bones. It is a miserable/painful demise.

Six 

Yes, urinary incontinence is a side effect of treatment, typically but not limited to a radical prostatectomy. A rectal fistula can occur from radiation therapy if not done properly. All of these complication are almost certain if you decide not to be treated, eventually the cancer will spread from the prostate to the bladder and rectum causing these and all sorts of other complications, unless you die before they occur.

Seven

Ok, I was wrong when I said there was only one thing I agreed with Dr. Jones about, I partially agree with this point too, if you are confused about prostate cancer, get as much information as possible before treatment. There are lots of good websites that have good information on treatment options. I too cast a wary eye on statistics, but this is not a pattern of statistics.

The question, I assume, is, should you get a PSA test? My answer is unequivocally, YES!