Tag Archives: radical prostatectomy

February 25, 2016 · 11:28 am

No pain, no gain?


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One of my patients last week had a heartfelt discussion regarding the survival benefit of ADT vs his quality of life. He enjoys body building and showed me some pretty dramatic pictures of himself during his last ADT cycle (on intermittent therapy) versus now, when he had been off treatment for ~6-9 months. Added to his concern was his decline in libido and sexual function during ADT, a common complaint especially among younger patients. The question of quality vs quantity of life was,of course, utmost on his mind.

Starting from the initial diagnosis, every (maybe that should be every !!) prostate cancer patient will experience a decrement in quality of life. Those who elect “watchful waiting” will nevertheless experience anxiety regarding the shadow of CANCER following their footsteps. Sure, you can put it out of your mind, but turn around and there it is, like the neighbor’s unwanted cat stalking you. Then there is the anxiety over what the next PSA will be. And if on active surveillance, what will that next biopsy show?? These issues are both real, disturbing, and often under-appreciated in the discussions surrounding screening…”we should still be screening, but not treat the men who don’t need it…” Really? What about the 80% of men who die at age 90 with prostate cancer at autopsy who never had to deal with the shadow? (The inevitable counter-argument is, “yes, and what about those who had early detection of a high grade cancer whose life was saved?”)

We also tend to ignore the impact of competing mortality in our discussions. “Sure you had a stent placed last year, and you already survived that small colon cancer, so why wouldn’t we be aggressive in treating this new problem?” Dr. Sartor provided an elegant discussion of this in an editorial on the PIVOT trial you can read here. Whatever the flaws in that study, it remains clear that we are not very good at predicting the non-prostate cancer “future” for our patients, and the older you are, the thinner the ice gets regardless of how many marathons you run.

When patients choose one form of primary treatment vs another, they are weighing the different side effect profiles of surgery or radiation as much as which is “most effective”. I often give patients a copy of this article from NEJM and encourage them to spend some time looking at the graphics in Figure 1 to get some idea of what they will face in the way of side effects from treatment. As any honest physician would tell them, treatment will involve side effects, some permanent, in the best of circumstances.

In the setting of more advanced disease, for example a patient who presents with metastases outside the pelvis, the recent CHAARTED and STAMPEDE trials both suggest an advantage to the earlier use of docetaxel chemotherapy in combination with ADT as opposed to ADT alone. These data suggest that “pay me now or pay me later” analysis favors the “pay me now” approach in terms of overall survival. But at what price for quality of life? Fortunately most chemotherapy side effects are reversible, but distinctly unpleasant, potentially making the equation something like “4 months of misery to provide 14 months of longer life….not all of which will be great anyway”.

Even in the very advanced setting, there is some evidence that greater toxicity results in improved survival. A recent analysis of the TROPIC trial of cabazitaxel suggested that the patients who had the most “toxic response” in terms of dropping their neutrophil count benefited the most in terms of overall survival.

While all of this seems incredibly negative (for which I apologize), the history of oncology as a field has been the incremental improvement in survival AND the development of newer treatments that provide such advances with diminishing toxicity. Pediatric leukemia, as discussed extensively in “The Emperor of All Maladies” is a great example of how pioneering patients and physicians worked together to find cures and reduce side effects. We may only be at the beginning of such achievement in prostate cancer, but with the advent of the newer hormonal and imaging agents, increasingly sophisticated surgery and radiation, vaccines and immunotherapy, and even the chemotherapies now available, we have  no doubt reached the end of the beginning. Onward!

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May 15, 2014 · 2:06 pm

Oh, no! My PSA is going up….do something….


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One of the most frustrating and frightening things that can happen to a prostate cancer patient is for there to be a recurrence of the PSA after he thought he had been cured by surgery, radiation therapy, or both. This is entirely understandable. It is no picnic to go through those treatments in the first place, and when the PSA is clearly going up, it can only mean (with very rare exception) that there are still cancer cells lurking somewhere in the body. The rate of the PSA rise can predict how long it will be until something shows up on a scan, and on average, this is about EIGHT years. The median time to death from prostate cancer after a PSA recurrence is 16 years.

For >95% of patients there is something that CAN be done to stem the rise in PSA. That is to go on hormonal therapy (androgen deprivation, ADT) which will drop the PSA, often all the way to undetectable levels, in over 95% of patients. Voila! Both patient and physician feel much better emotionally. But for the patient, there is a significant price to pay. Namely the hot flashes, loss of energy, weight gain, bone calcium loss, lack of libido and further decrease in sexual function to name a few. The question is whether this is “worth it”.

A study to be presented in the next few weeks at ASCO’s annual meeting, suggests it won’t make much difference if you start ADT early versus waiting until metastases, or perhaps even symptoms occur. Utilizing the CaPSURE database, the investigators evaluated over 2000 men who had PSA relapse. The estimated 5 year overall survival (87% vs 85%) and 10 year overall survival (72% vs 72%) were the same regardless of whether the men received immediate or delayed ADT. The same was true for death from prostate cancer…no significant difference. There are of course other considerations that may come into play like treating those patients who have highly aggressive disease earlier because one knows that there will be metastases within a year, or the patient simply can’t live with himself knowing his PSA is going up.

In my experience, it is the exceptional patient who is willing to go play golf or travel or enjoy his grandchildren and forgo PSA testing on a regular basis. I have trouble even convincing my patients to extend their PSA testing to 6 months from 3 months. The question is, does it make any sense to watch this “number”, any more than it would to have cardiac catheterization every 3 months to follow the slow but inexorable accumulation of calcium in your coronary artery? Or what about the 0.01 mm increase in your abdominal aortic aneurysm? Or the accumulation of two more tangles in the Alzheimer plaque in your brain. Just because we CAN measure PSA so easily certainly doesn’t mean we SHOULD, and I have seen far too many men let this number ruin their otherwise healthy lives.

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April 15, 2014 · 8:51 pm

Radicals, Robots and Reimbursement


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So how did the robot take over??? As I recall, it started with “hospital A” buying the fancy robot for their urologists to use, after said urologists insisted that this was the way of the future. The Intuitive Surgical Company did an outstanding job of selling the technology. I remember going to our parking lot, going into a fancy 18 wheeler, and playing with the robot, tying a few knots on a fake surgical template, and thinking “really cool”. Of course any boy (and probably a lot of female surgeons as well) loves new toys. Why only this last Christmas, I bought myself and my adult children several of the very cool (and I still recommend them for your toy loving children by the way…) RC indoor helicopters.

But back to “hospital A”. The results of their investment of about $2M plus several hundred thousand in maintenance costs was that patients flocked to their urologists to get their prostates removed by the “new, improved….step right up sir” technology. And of course our hope was that there would be improvements in cure rates, preservation of potency, and less incontinence since there was NO doubt that the surgeons could see their tissues better, control their shakiness, and relax at a console rather than accomplishing the acrobatic feats required for reaching way down behind the pubic bone to get at the evil prostate. And so….the urologists at “hospital B” started losing cases and lobbied their hospitals to take the plunge and also invest. In the end, robotic surgery replaced open prostatectomy in 85% of cases. But, in the three areas patients care about most – cure, potency, continence – there was no improvement. There were very small improvements in blood loss (which for most patients never requires transfusion anyway), time in hospital (reduced from something like 28 hours to 24 hours), and pain (which has always been very minimal anyway, usually handled easily by a few vicodin tablets for 2-3 days). But Intuitive made out like a bandit. Their stock price soared from $12.75 on Dec 22, 2000 to $540 on Apr 3 of 2014. I should have seen this coming!

And now comes this article in today’s JCO: Comparative Effectiveness of Robot-Assisted and Open Radical Prostatectomy in the Postdissemination Era. The authors use the SEER database to evaluate open versus robotic radical prostatectomy (RP) in 5915 patients who had their procedures done between 10/08 and 12/09. 42% of the patients had open “old fashioned” open RP’s (ORP) while 59% had robotic RP (RARP). As stated in their abstract, “patients undergoing RARP had similar odds of overall complications, readmission, and additional cancer therapies compared with patients undergoing ORP. However, RARP was associated with a higher probability of experiencing 30- and 90-day genitourinary and miscellaneous medical complications (all P ≤ .02). Combined with numerous other articles showing no improvement in cure, potency, or incontinence, this paper adds to the rather sad tale of how sometimes our technology leads to higher costs with minimal if any benefit. You can read elsewhere in this blogsite about similar findings with proton beam therapy. “Let the buyer beware” should become a more frequent paradigm for medical advances. Of course if Medicare did this, we would hear the chorus chant the echo chamber commentary on how “government is stopping us from getting the care we deserve”. If you like this system, just continue to vote for no change in how we deploy our Medicare tax dollars.

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March 22, 2014 · 10:28 am

No surgery or radiation. Just make my PSA go down!


To read this blog on the website and have access to subscribing and older posts click here. What if you could avoid all of the well-known side effects of surgery or radiation and just take hormone therapy? (aka Androgen Deprivation Therapy or ADT) Given the incredible power of the PSA value to drive thinking of both physicians and patients, this question makes a lot of sense. >95% of patients will have a PSA response to ADT, usually in the form of GnRH agonists (e.g. Lupron, Zoladex, Trelstar, etc) or antagonists (Firmagon, Plenaxis) You might imagine that dropping the PSA would be all that is needed in some men and if they didn’t have too many side effects (weight gain, hot flashes, muscle weakness) they would benefit from the treatment.

A study just reported looked at 3435 men treated in this way between 1995 and 2008 to determine if such treatment would reduce death from prostate cancer and compared them to 11735 men who did not receive such treatment. The age ranged from 35 to >80 and as you might suspect, there was a statistically significant tendency to use treatment in older individuals, in men with higher PSA at diagnosis, and in those with higher Gleason scores. Anyone who received radiation or surgery within the first year after treatment was excluded from the analysis. The bottom line is that there was no effect of using such treatment. To quote the authors, “Our main conclusion is that PADT does not seem to be an effective strategy as an alternative to no therapy among men diagnosed with clinically localized PCa who are not receiving curative-intent therapy. The risks of serious adverse events and the high costs associated with its use mitigate against any clinical or policy rationale for PADT use in these men.”

This study adds to the complexities surrounding prostate cancer diagnosis and treatment. Screening and treating patients with surgery or radiation after age 65 may not produce any positive results in the large screening studies, or at the least, you have to treat a significant number of men who would not need treatment to save one life. While you can make the PSA go down with ADT, it also does not save any lives. Such is the challenge of whom to diagnose, whom to treat, and how to best treat anyone who you think does need treatment. On this blog you will find many entries on these issues, and as I have stated before, when you ask men who are dealing with the disease, they virtually all think their treatment either saved their life or was given too late – illustrating the difference between a population and an individual view. The silver lining is that whether you are diagnosed with pca before you die or not, regardless of treatment choice, you are more likely to die from something else.

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Is medicine a profession or a business?


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I have been thinking about writing a blog like this for some time. So first let me make some disclosures: ONE: I am generally a “liberal” and would favor a single payor health care system. TWO: I grew up in a small town in Nebraska where the local doctors were beloved, cared for the families in our town, and drove Buicks (BMWs, Teslas, Lexi, etc. were unknown – the two bankers drove Cadillacs) THREE: Medicine was much less complex, much cheaper, and much less effective. FOUR: I have had a wonderful career in academics where I received a paycheck from the State of Colorado and was usually required to earn >90% of my salary through grants or clinical earnings – I could talk more about “tenure” if anyone is interested. Academic salaries are generally less than private practice, but the advantages of no/minimal night call and working with residents and students and exploring new treatments in the lab and clinic are great rewards that can’t be measured in dollar terms.

With that out of the way, I remain saddened by what has happened to my profession. For all kinds of reasons, many physicians now consider themselves as much “small businessmen” as they do physicians. As the business of medicine has become more and more complex, they provide jobs for increasing numbers of staff, pay higher malpractice premiums than they used to, and look for ways increase their incomes. But few if any are missing any meals, and many are privileged to be in the top 1% of wage earners. Nothing wrong with that.

BUT… This week’s New England Journal article exposes a very disturbing issue that I happen to know a lot about. Some urologists, who only a decade ago were constantly arguing with their radiation therapy counterparts on how much better surgery is for treating prostate cancer, have been buying radiation therapy equipment and hiring “their own” radiation oncologist to run the equipment, then self-referring. The reason is obvious and it has nothing to do with what is best for patients. It is to increase their already very substantial incomes, which (to be fair) have been decreased somewhat by lesser reimbursement for surgery, less for giving lupron, and no doubt other cuts. The outcome of radiation and surgery treatment in terms of cure is the same. The side effects are somewhat different and deserving of discussion with each man who chooses treatment. The figure shows the magnitude of this trend.

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There are many examples of similar trends when doctors stand to make money by ordering tests, buying their own equipment, setting up their own “surgicenters”, or in my own subspecialty, giving one chemotherapy that has a higher reimbursement than another that is equally efficacious. Other articles have dealt with how hospitals maximize their profits with the “chargemaster”. And still others have dealt with the practice of pharmaceutical companies charging huge amounts for novel drugs – expensive to develop for sure, but also hugely profitable.

So the answer to my question seems to be that medicine is both a profession and a business. My view is that the patient should always come first, not the pursuit of profit. Thus there is a built-in conflict if the goal of business is to make as much money as possible. Herein lies the challenge for our health care system. I don’t have any idea if the ACA will help, but I do know that the current system is in dire need of reform, and that the entering medical students who say they want to be doctors “because they love science and love people” will have a long ways to go in realizing that dream if there aren’t changes.

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October 27, 2013 · 5:29 pm
November 7, 2012 · 5:33 pm

Profiting from “YOUR” prostate


Medicine is a business. I get that. It is also a wonderful professional calling and being both at the frontiers of science like the genome project as well as holding the hand of a patient who is asking about whether he should try one more desperate treatment is a remarkable privilege. Since I started my medical practice 34 years ago, the changes in both business orientation and in the technologies of medicine are breathtaking. All of that said, I remember when the doctor in my home town of Chadron, Nebraska, made house calls, drove a Buick and lived a few blocks away in a very modest house. Making himself rich was really not part of the equation, although he did well enough to send his kids to fine colleges and eventually build a nicer home.

The skewing of medical practice towards being a “small business” and away from a profession bothers me. Even though I agree with my sister who married a wonderful cardiologist and has a remarkable estate that “once doctors could actually DO something, it became a transaction”, it simply bothers me. My introduction to this real world started when we participated in the development of leuprolide, giving the first patients small but increasing doses, assessing saftety, and eventually designing the trials that led to FDA approval. When the price for a 3 month injection was announced, I was astonished. When a “me too” drug came out called Zoladex, I thought that the competition between pharmaceutical companies would drop prices. It didn’t. Instead, companies competed on behind the scenes pricing schemas that began to corrupt the doctors prescribing the drugs. Eventually (though not soon enough to save billions of dollars to our Medicare system), there was a whistle blower who got enough attention to stop the practice.

Now we find that business and profit have become the (maybe that should be THE) driving force in medical decision making. Urologists who used to make large sums of money off of the drug markup schemes with lupron, changed over to doing more orchiectomies as soon as the profits fell off. The study documenting this found the following: “The use of medical castration increased from 2001 to 2003, whereas, over the same period, surgical castration decreased. Total allowed charges for medical castration peaked in 2003 at $1.23 billion. After the enactment of the MMA, surgical castration rates increased, and medical castration decreased. Total allowed charges for medical castration in 2005 dropped 65% from the 2003 peak.” In other words when the profits for giving Lupron fell, surgeons started doing more surgery and stopped giving leuprolide shots in their offices.

Now the focus has shifted to seeing if more money can be made doing radiation therapy than surgery. Medicare has decreased the compensation for doing prostate surgery.  Some large urology groups have formed and purchased their own radiation therapy equipment. .No problem with that if their practice of recommending surgery versus radiation for patients hasn’t changed. However the data for some of these groups suggests that is not the case. In a recent article from Bloomberg, the profit motive influences more and more urologist’s decision making. “one in five U.S. urologists add to their income by billing for the type of treatment in question, according to the journal Urology Times. Called intensity- modulated radiation therapy, or IMRT, it uses imaging software to focus multi-angled X-rays on tumors, aiming to deliver bigger doses with fewer side effects than prior technologies. This side business pays doctors up to $40,000 per patient from Medicare, or 645 times what a urologist gets for a standard office visit, and as much as 20 times what the federal insurance program pays a surgeon to remove a cancerous prostate gland, according to published studies. Reimbursement from private insurers for IMRT can be even higher, urologists say.”  Dr. Cooperberg, of UCSF is quoted as follows: ““Doctors do what they’re paid to do” Cooperberg said. “If you tell them they can earn $2,000 for surgery or $37,000 for IMRT, what do you think will happen?”

The article goes on to state: “When urologists have a financial stake in IMRT, the portion of patients referred for it roughly triples within about two years, according to preliminary data presented at a radiation oncology conference in Miami Beach last year by Jean Mitchell, a health-care economist at Georgetown University.”
I find all of this very sad. I know dozens of urologists who are absolutely terrific and would never let profit influence their decisions on a treatment recommendation. I also know radiation oncologists who are incensed that urologists are invading their own profit making world, and of course there is no shortage of medical oncologists who “struggle to make ends meet” by giving the most expensive chemotherapy when they should be referring patients to compassionate hospice care. My point is that I don’t think very many medical student applicants start off with making money as their motive for going into medicine. I am disappointed in what my profession seems to do to some of them. I love medicine as a profession, not as a business.

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August 14, 2011 · 9:37 am

Prostate cancer in nodes etc.


I ran across an article I had archived that may be of interest to some patients contemplating surgery. The USC group, where Dr. Skinner has been a pioneer in working on the proper methodologies for lymph node dissection at the time of radical bladder surgery for cancer, reported excellent outcomes in men whose positive lymph nodes were removed at the time of surgery. To put this in context, in the 1990’s our urology group was holding sessions to teach laproscopic node sampling. The idea was that if you found positive lymph nodes, a patient can’t be cured, so there is no reason to do a prostatectomy with the risks for incontinence, impotence, etc. However, even back in the 1980’s, the Mayo Clinic had reported excellent results for men with positive lymph nodes and diploid cancers who were treated with castration, suggesting that nodal metastases aren’t always fatal.

Another perspective on this comes from testis cancer, where retroperitoneal lymph node dissection reduces the relapse rate by about half after orchiectomy. Or, we can consider the issue that even though finding lymph node involvement in breast cancer is a negative prognostic finding, some patients are cured. In the Southwest Oncology Group, we reported preliminary results on patients with high risk factors like positive nodes who received two years of adjuvant androgen deprivation therapy.

My conclusion from all of this is that if I were to choose surgery to treat my newly diagnosed prostate cancer, I would want ample node sampling, completion of the prostatectomy regardless of whether there is nodal involvement, and would take adjuvant hormonal therapy (probably 2 years minimum, depending on how bad the side effects were in my case) and hope that I was cured. In thinking about this, one wonders about how many patients who have already received surgery, salvage radiation, but have persistence of a rising PSA, might still be curable with drastic surgery to remove all the pelvic contents (pelvic exenteration). This procedure has been done for some gyn cancers, sarcomas and the like but is seldom used in prostate cancer. It is obviously difficult to recommend such a procedure without some confidence that cure is possible. A brief review of the topic is here. The challenge is made more difficult by the fact that the majority of men would have much better quality of life by opting for hormonal therapy, even if it isn’t curative.

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