5-year cumulative incidence of complications after surgery or radiation therapy

A new report just published in Lancet Oncology provides data on complications other than incontinence and erectile dysfunction (ED) after surgical or radiotherapeutic treatment of prostate cancer within 5 years of the initial treatment. Although incontinence and ED are widely considered to be the most common short- and long-term complications of standard first-line treatments for localized prostate cancer, it is clear from this study that they are far from being the only well-recognized complications.

The Canadian research team (Nam et al.) conducted a retrospective, population-based cohort study that used administrative hospital data, physician billing codes, and cancer registry data for men who underwent either surgery or radiotherapy alone for prostate cancer between 2002 and 2009 in Ontario, Canada. The researchers identified the 5-year cumulative incidence of five treatment-related complication endpoints: hospital admissions; urological procedures; rectal or anal procedures; open surgical procedures; and secondary malignancies.

Here is a summary of the key findings:

  • The study encompassed data from 32,465 patients.
  • The 5-year cumulative incidence of admission to hospital for a treatment-related complication was 22.2 percent (but was only 2.4 percent for hospital admissions longer than 1 day)
  • The 5-year cumulative incidence of specific procedures was
    • 32.0 percent for urological procedures
    • 13.7 percent for rectal or anal procedures
    • 0.9 percent for open surgical procedures of any type
  • The 5-year cumulative incidence of a second primary malignancy was 3.0 percent.
  • These risks were significantly higher than were those among 32,465 matched controls with no history of prostate cancer.
  • Older age and one or more comorbidity at the time of index treatment were important predictors for a complication in all outcome categories.
  • Type of treatment received was the strongest predictor for complications.
    • Patients who underwent primary radiotherapy had  a higher incidence of complications for hospital admissions, rectal or anal procedures, open surgical procedures, and secondary malignancies at 5 years than those who underwent primary surgery (adjusted hazard ratios  [aHRs] = 2.08 to 10.8).
    • Number of urological procedures was lower in the radiotherapy than in the surgery group (aHR = 0.66).

The authors interpret the results of their study as follows:

Complications after prostate cancer treatment are frequent and dependent on age, comorbidity, and the type of treatment. Patients and physicians should be aware of these risks when choosing treatment for prostate cancer, and should balance them with the clinical effectiveness of each therapy.

It is worth noting that this study has been conducted by Klotz and his team from the University of Toronto, and they would likely be of the opinion that the frequency of complications listed above is yet another reason why active surveillance may be an appropriate form of management for men with relatively lower-risk forms of prostate cancer (as compared to immediate intervention using surgery or radiation therapy).

16 Responses

  1. “other than” … Guess those are just trivial issues not worth considering “complications”.

  2. Dear Tracy:

    To the contrary … I think the whole point of this paper is to emphasize that there are a lot of other serious complications in addition to the two most widely recognized serious ones.

  3. Yeah, that’s not a dig against ED and incontinence sufferers. No way. Not the point of the contrast.


    This study makes the useful point in its conclusion that we should be aware of these risks, and we should take to heart Sitemaster’s point about the role of active surveillance. However, regarding radiation, it seems likely the risks, which were not high to start with as documented in this study, are likely considerably lower now due to the advent of advanced technology in dosing, staging the case/identifying the location of the cancer, targeting the cancer/controlling movement of the target, and adjuvant support.

    I know this period well regarding radiation as it spans roughly the middle half of my 14 years as a prostate cancer survivor, at the start of which I was headed toward radiation therapy (turning away just before tattooing in preparation for a mix of conventional and 3D-CRT, and placing my trust in ADT, having been rejected, wisely, for surgery), and throughout which I maintained some interest in radiation for myself, which culminated eventually in 39 sessions of TomoTherapy IMRT last year. While the Ontario situation, with its noted physicians and facilities, was probably somewhat different from what was going on in the US for radiation, I suspect it was reasonably similar and will make that assumption regarding the points below.

    In the early years of the study, around 2002, radiation in the US was emerging from reliance on conventional radiation and was moving into 3D-conformal beam radiation therapy (3D-CRT). IMRT was not much in the picture, though it was employed at advanced centers. A paper by Leibel and others (including Dr. Zelefsky) in 2003 describes the highest dose possible with conventional radiation as “70 Gy, the maximum feasible with traditional two-dimensional (2D) treatment planning and delivery techniques”, noting that dose was inadequate for some prostate cancer cell populations. The paper goes on to note that 3D-CRT permits higher doses, and it mentions IMRT as an advanced option. Also in 2003, in November, Dr. Zelefsky and colleagues reported results using 3D-CRT and IMRT, with a median dose of 75.6 Gy but with some receiving 81 Gy or higher, with the latter group having superior cancer control. Around this time a number of other papers from leading centers were also reporting results with high doses of around 78 to 81 Gy, but it is quite clear that such high dosing was not the standard of practice, and there was uncertainty, as reflected in papers, about the added side effect burden and the need for ADT in support.

    Now, in 2014, even more so than in 2009 (the last year of activity in the study), IMRT is a standard and easily able to deliver that higher range of 78 to 81 Gy safely, with confidence based on research. Also, we now know that added ADT is not necessary for lower risk cases. Issues like the need for supportive pelvic radiation therapy (in addition to the prostate and seminal vesicles) are also much more clear. Staging the locations, shapes and sizes of the cancer is also far more advanced, as is patient positioning and target confirmation technology.

    All of this makes it likely that the rates and burdens of complications of radiation with advanced methods today would be considerably lower than the already fairly low rates and burdens in the study period. These developments were major factors in my deciding to do staging for radiation eligibility and then have radiation in 2013 for my advanced case.

  5. Dear Jim:

    The patients treated in this study were not (by any manner of means) being treated at major centers. They encompass patients treated across the whole of Ontario during this time frame, and I think you might be surprised to find how many different radiology clinics across America and Canada today are still using 3D-CRT equipment to treat prostate cancer patients.

    While I would agree with your general premise that the risks for complications of any type (post-surgery and post-radiation therapy) have been falling slowly over time, I would also respectfully submit that the authors primary point is a very simple one … that a lot of prostate cancer patients suffer a lot of consequences from their initial treatment over the next 5 years, and things like ED and mild incontinence may be the ones they get told about, but they certainly aren’t the only ones they should be aware of.

    Once you get outside the major centers, not everyone in the radiation oncology community has a PhD along with their MD, and just because s/he has access to IMRT equipment (if s/he does) doesn’t mean that s/he is able to use that equipment with the requisite level of skill and experience. We are all aware there are surgeons doing radical prostatectomies who probably shouldn’t be allowed to pick up a scalpel. In the same way there are quite certainly radiation oncologists radiating prostate cancer patients who should be asked to hand in their key to the radiation oncology suite. You have the knowledge and the insight to be able to avoid such risks. Others are not necessarily as wise … or they may not have the resources to seek better options.

  6. Hi Sitemaster,

    Regarding your comment on wisdom, I’m reminded of the saying: Good judgement is based on experience; experience comes from bad judgement.

    Thanks for making that observation about the distribution of advanced radiation technology, or, more to the point, the shortage of such distribution. Actually, that was true for me as well, back in the first 6 months of 2000 when I was on a steep learning curve about prostate cancer after a diagnosis in December, starting from the point where my impression was the maximum PSA score was 10, and I had not heard of a DRE. (Fate sure must have laughed long, hard, and often in teaching me thoroughly what those tests were about!)

    Back then, places like Memorial Sloan-Kettering (Dr. Zelefsky and colleagues) and the Cleveland Clinic (Dr. Kupelian and colleagues) — both institutions practically “neighbors” of Toronto (curious about the interaction of the medical communities in those pre-Internet days) — were already investigating higher dosing (such as 78 to 81 Gy with IMRT), perhaps Fox Chase in Philadelphia and other leading radiation centers were investigating as well, but many well-known institutions, like Johns Hopkins, where I consulted then, were not. One of the reasons I decided not to pursue EBRT there was that I could not get a direct answer about the proportion of conventional radiation and 3D-CRT planned for me; I was also not fully satisfied with the information about side effects. (I was told that my chances of cure were fairly low, a major factor in my decision to rely on ADT instead as my sole therapy.) In short, I was very much in the shoes of the trusting but effectively unknowledgable patients you highlight, and my radiation oncologist at Hopkins did not effectively grasp my need for information despite my repeated questions, again a concern you emphasize.

    This is a long way of saying that I appreciate your point that patients need to be told about these side effects in today’s practice environment. That said, it is also true that the upper level of technology and practice appears to be quite superior to what appears to be the norm for treatment. Hopefully the advances being implemented today will become standard practice within a few years.

  7. Jim,

    I always enjoy reading your insights on prostate cancer.

    In 1997 my father died of prostate cancer 5+ years after having radiation. His diagnosis came after a TURP and in 1992 radiation was the norm. I myself have gone through three biopsies, with the first in 2004 (PSA 6.5). The last one in the Spring of 2013 at age 65 was a saturation with 24 core samples. This was recommended because of (1) family history, (2) a rising PSA (latest was 8.4), and (3) a PCA 3 test result of 51. All of the biopsies were “negative”. I am due for another PSA in March 2004.

    My largest worry is needle contamination from possibly striking a (prostate cancer) cell during the course of biopsy spreading a dormant disease. I haven’t heard to much on this subject. For now it is fruit and oatmeal in the morning for breakfast, a handful or two of nuts in the afternoon and red meat only on occasion. I also take simvistatin for high LDL. I’ve also read that statins lower risk of prostate cancer and wonder what the sitemaster would say.

    I write to share my experiences in the hope I can be of help.

  8. Dear Jim:

    I would make three points in response to your comments:

    (1) The number of men who have ever been diagnosed with clinically significant prostate cancer after three negative biopsies is, as far as I am aware, vanishingly small.

    (2) The risk for development of prostate cancer as a consequence of “needle tracking”, as you describe, is a theoretical possibility, but it has never actually been observed and reported — ever. A key reason for this is cancer cells need a very specific biological microenvironment to develop and grow. The vast majority of cancer cells that move from one place to another within an organ or within the body will die because their new environment is not conducive to their growth,

    (3) While there is a great deal of evidence of an association between long-term survival and the taking of statins (in men with and without prostate cancer), as yet we have no actual, reliable. clinical evidence (of cause and effect) that statin therapy can either prevent the onset of prostate cancer or extend the life of a man diagnosed with this disease … but go on taking the simvastatin anyway; you have an elevated LDL.

  9. I have been treating soft tissue radiation necrosis, radiation proctitis, and radiation cystitis in hyperbaric centers for many years. After seeing the late effects of radiation therapy, I made up my mind a long time ago that radiation therapy is not an option for prostate, or any other cancer, for me. I may possibly have prostate cancer right now, and if it is discovered that I do, I’m going straight to Tijuana to be treated in a Gerson clinic. Far better success rates than American oncologists. Cancer treatment in this country remains archaic.

  10. Dear Greg:

    With regard to the late effects of radiation therapy for prostate cancer (I can’t speak to other forms of cancer), if one spends years and years having to deal only with the relatively small percentage of patients who have these types of serious complications (and it is only a small percentage today), your reaction is hardly a surprising one. Whether it is actually the right reaction is a whole different question … especially if you have low-risk disease and don’t really need immediate treatment at all.


    Hi Greg,

    When I was starting out on this 14-year (and counting) journey, some members of my family encouraged me to do Gerson therapy — the coffee enemas, etc. My father had done it for his own prostate cancer, from which he died. I looked into it and found only one sketchy trial; the results were that every patient died of prostate cancer (about 20 as I recall).

    We have had a number of deaths, not many, from prostate cancer among the many attendees at our Us Too support and education group. The only one of us who favored Gerson therapy was among those who have died. (I recall somewhat hazily that he may have also had some standard therapy.) I have looked more recently for research on Gerson and have found nothing credible.

    My take on Gerson therapy that is that it is an excellent walletectomy. If a heavy wallet is the root of anyone’s problem, I suspect Gerson will do a fine job of reducing its size.

    While I am obviously opposed to Gerson therapy, I will be happy to change my view if anyone can come up with solid evidence — the type published on http://www.pubmed.gov — that it is effective. Anecdotes don’t count — not worth a damn.

  12. Jim,

    I read his book on 50 case studies, and studied additional sources from brilliant physicians who worked in conjunction with him. It was very informative. The AMA tarred and feathered him years ago (they don’t like positive results from methods they deem “quackery”; makes them look bad), hence he opened clinics outside the US.

    A prominent surgeon in Japan was diagbnosed with a stage IV cancer, studied Gerson, and went to his clinic. The man was completely cured, and worked with the health minister in Japan to use the therapy in their system. They have had great success.

    You aren’t going to read anything positive published in peer reviews about anything natural, because it takes $$ from the system. Our system is designed to keep people enslaved to it, that’s how it survives. I’ve read enough, and have seen enough documented testimonials, that I would go that route. Compared to the cost of traditional treatment, it’s pennies. A 2-week stay at their clinic is about $15K. Chemo and radiation are easily more than 10 times that amount, with all the complications, which amounts to additional untold thousands more. There are people who die during all sorts of therapy. At least with Gerson, you can die still being able to urinate and defecate, while keeping your hair, and your immune system.

  13. Sitemaster,

    The complications and late effects of radiation on head and neck cancers are far worse than even prostate or colon cancers, which are bad. I’m not sure where you get your stats, but “a small percentage” is not real accurate. Oncologists in this country could learn a lot from their peers in Europe.

  14. Hi Greg,

    I’m not sure anything I or anyone familiar with actual medical science could say would alter your opinions, but you are far, far off base regarding prostate cancer, including your concept of what you evidently view as typical frequency and severity of side effects, therapies commonly used for most patients, and their costs. I’m saying that not only based on published research (typically roughly 6,000 published papers per year on prostate cancer), but also, from my own viewpoint, on talking with many patients and researchers over the years and experiencing ADT and radiation myself.

    You are also evidently unfamiliar with a large body of published research on “natural” items to counter cancer. Contrary to what you believe, there are many such studies in the peer-reviewed journals. Put this to the test by looking at research on pomegranate elements and prostate cancer. The place to go is known as PubMed, at http://www.pubmed.gov, a site sponsored by the National Library of Medicine under NIH. Try this search string (without the quotation marks): “pomegranate AND prostate cancer”. I just did that and got 59 hits. You can also check out papers on modern radiation and its side effects at PubMed. That’s where Sitemaster and many of us get our reliable stats.

    As for that $15,000 2-week stay at the Gerson clinic, if there is no benefit, then that expenditure amounts to an expensive walletectomy.

    Regarding that Japanese experience you mention, if there has been “great success”, it will almost certainly be documented in a respected journal. The Japanese medical research community publishes a large body of studies and these are picked up by PubMed. I’m skeptical there are any published studies because I suspect this anecdotal account of a stage IV cancer would fall apart on careful examination. A typical fault with such anecdotes is that there is no actual diagnosis by standard methods, just assumption of the cancer and stage. Prove me wrong!

  15. Maybe you should quote Barrett while you’re at it. He’s a great, reliable source for truth, funded by AMA members, of course. I have also witnessed first hand, how research can be skewed to gain desired results. Haven’t you seen the myriads of litigation in regards to disastrous side effects from drugs approved by our FDA?

    I don’t need to prove anything. The results speak for themselves. I have witnessed, first hand, many train wrecks of modern medicine’s answer to “cure”. You can’t cure a disease if you don’t treat the cause, and anyone with any knowledge of what’s being taught in medical schools knows that symptoms, not cause, are what’s focused on for treatment — with drugs, with surgery, with radiation, etc. Not good medicine in my book. I have treated myself for various illnesses, and have had good success, because I went after the cause, not the symptom. I have a gallbladder, because I ignored the advice of a primary care physician, and performed a liver and gallbladder cleanse; no more attacks. I have taken care of skin problems by diet change. When you learn something about nutrition, and what the body needs to strengthen the immune system, then you’ll have a better picture of what the natural medicine providers are all about. Cancer is a trillion dollar industry, and that money is going into the pockets of pharmaceutical industries, and oncologists.

    You might also want to look into the cancer rate among oncology nurses, not a pretty picture. You don’t cure a disease by pouring dangerous toxins, that have to be handled with extreme caution, and that destroy your immune system, into your body. That makes about as much sense as the old side show snake oil peddlers.

  16. Jim, Greg:

    That’s enough. This conversation has progressed (as always) into views about what constitutes meaningful science. It has nothing helpful to do with the management of prostate cancer. And I wish to be very clear that The “New” Prostate Cancer InfoLink doesn’t endorse any particular form of medical care — there are as many really bad radiation oncologists and bad surgeons as there are bad nutritionists and other forms of alternative care providers.

    I am not going to approve any further comments on this topic unless they are very, very specific to benefits for well-defined categories of men with prostate cancer

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