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A SIMMERING turf war in the world of prostate cancer has been reignited this month with the publication of new follow-up data from the Prostate Cancer Intervention versus Observation Trial (PIVOT), which randomised men with localised disease to either surgery or observation only.
Now with nearly 20 years of follow-up, the trial of 731 US veterans found that compared with observation, prostatectomy was not associated with significantly lower all-cause or prostate cancer-related mortality. On the other hand, it did significantly increase the frequency of adverse events.
Elsewhere in this issue of MJA InSight, Associate Professor Ian Haines and Dr George Miklos argue that this new data brings a “stunning” clarity of evidence to the issue of surgery in early prostate cancer.
The two authors are opposed to prostate specific antigen screening and say that PIVOT, together with the Prostate Testing for Cancer and Treatment (ProtecT) trial – which showed no outcome differences between observation, surgery or radiotherapy in localised disease – make it “abundantly clear that radical prostatectomy, robotic or otherwise, for early-stage prostate cancer is becoming outdated”.
But the urologists aren’t taking it lying down. Dr Daniel Moon, director of robotic surgery at Melbourne’s Epworth HealthCare, is dismissive of the PIVOT data.
“It’s flawed, majorly flawed,” he told MJA Insight. “The main problem with this study, and why it’s impossible to draw any meaningful conclusions from it, is that it recruited elderly veterans, many in their late 60s with a lot of comorbidities. So, from the outset you’ve selected a cohort of men who are the least likely to benefit from prostate cancer treatment. Because we all know from guidelines and recent recommendations that the men who actually benefit from screening are those without comorbidities and a life expectancy of 10-plus or preferably 20 years.”
Dr Moon added that, in any case, PIVOT’s recruitment had fallen significantly short of its target, which meant that it was statistically underpowered.
“Choosing men who are pushing 70 years with a lot of comorbidities, finding a lot of low risk disease and then randomising them to treatment or non-treatment is never going to show anything,” he said.
Shomik Sengupta, a Professor of Surgery at Monash University and spokesperson for the Urological Society of Australia and New Zealand, agreed that PIVOT had significant limitations and was focused on the wrong patients.
“If you look at this trial, it’s an older group of patients and it’s going back 20 years when a lot of lower risk cancers were treated. Nowadays, you wouldn’t enter patients like that on to a treatment trial. You’d put them on active surveillance. There are exactly the same issues with the ProtecT trial. When you look at the risk profile of the patients on that trial, many wouldn’t be offered treatment today.”
But the controversies surrounding prostate cancer don’t all revolve around the pros and cons of surgery versus active surveillance. Several studies, such as the aforementioned ProtecT trial, have suggested that for the higher risk patients who do need an intervention, radiotherapy is just as effective as surgery, but with fewer of the distressing side effects, such as incontinence and impotence.
However, patients are not always told about radiotherapy, according to Associate Professor Sandra Turner, a radiation oncologist at Sydney’s Westmead hospital. While they are always initially referred to a urologist for biopsy and diagnosis, they often do not get to see a radiation oncologist afterwards.
“The surgeons are the gatekeepers,” she told MJA InSight. “They like to deny it, but they are. There’s a massive financial conflict of interest there, because they don’t have a vested interest in referring men on to a radiation oncologist. They lose income if someone chooses a non-invasive intervention. People are reluctant to say it, but that’s the elephant in the room.”
Dr Turner said that the financial incentive was all the greater because most prostate cancer surgery happens in the private sector, which can leave patients with huge out-of-pocket expenses. By contrast, most radiotherapy occurs in public hospitals, she said.
She added that she often saw patients who had been referred to her because of positive surgical margins, but who had not been told that they could have initially had radiotherapy instead of surgery.
The upshot, she said, was that men who require treatment for their prostate cancer are two to three times more likely to get surgery in Australia, despite evidence that the procedures have similar efficacy.
Professor Sengupta said he didn’t believe financial incentives drove urologists’ treatment recommendations.
“This ends up getting levelled at us all the time. If inappropriate advice is given for financial reasons, that would be a serious concern. But I don’t think there’s any evidence that it happens. I think the move to active surveillance for low risk cancers actually undermines the argument that urologists are motivated by financial gain, because if you put a patient on surveillance, they’re not getting surgery. And these patients are often more labour-intensive, because you’re spending a lot of time counselling them.”
He said that most urologists work both in the private and public sector, so surgery could generally be done in a public hospital. And he added that certain radiation treatments could also end up costing patients quite a lot.
“Personally, I would never operate on a patient if I thought it was against their best interests, and I’m sure that’s the case with all my urology colleagues. I think all of us who are reasonable, whether radiation oncologists or urologists, are working together to promote multidisciplinary care. And I don’t think the vocal criticisms of one specialty group over another are particularly helpful.”
But the debate between urologists and radiation oncologists is likely to rumble on. If one accepts the urologists’ argument that the key prostate cancer trials are flawed, that leaves us with little evidence to go on as to the efficacy of the various treatments. And radiation oncologists complain that it also leaves us with a referral pathway that begins with the urologist.
Meanwhile, it may be worth pondering the results of a US study, which compared the recommendations of urologists and radiation oncologists for the treatment of localised prostate cancer. Surprise, surprise: for the same cases, the specialists overwhelmingly recommended the treatment that they themselves delivered.
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I was, and still am a victim of PSA screening, which led to the dangerously painful biopsy procedures, bone scans, and the subsequent deadly Radical Protestatom. I was told by my urologist that I had End Stage 4 Prostate Cancer which required immediate surgery. The surgery was carried out in 10 days at the Lions Gate Hospital in North Vancouver, British Columbia, Canada, I was 50 years old at the time, and I had no symptoms.
It my first annual physical in the summer of 2013, my GP included PSA screening as part of the series of blood test. Of course, my GP never took time to discuss the risks and benefits with in regard to the PSA screening. My PSA reading was high. I didn’t know how high because I was never given the results of any of blood tests. I was immediately refer to a young urologist who urged me to go for a biopsy and bone scan. Two weeks later, the urologist called me to go his office for the biopsy and bone scan results. I went there to the uologist’s office as scheduled thinking to myself what could go wrong with the results since I was in perfect health – a 2-time marathon runner with weight traing five days a week, and a healthy eater with insatiable sex life. The urologist came into the office, he wasn’t very cheery and he sat down beside me. He took out a stack of papers for me to sign ( they were consent forms for Radical Prostatomy). He explained to me that my prostate cancer had spread into nearby organs, and had metasized into my bones; therefore, I had the classic symptoms of the last stage of prostate cancer with little over 6 months to live, and at the most 3 to 5 years at the most. The only choice of treatment available to me was Radical Prostatomy. I was shocked upon hearing his diagnosis, and immediately signing the consent forms. I asked my urologist that if I had no symptoms, no pains, blood in my semen or urine – things that would normally associated with very advanced prostate Cancer? He responded that it was typical that stage 4 prostate cancer normally had no symptoms, that was why the prostate cancer was the silent killer. I asked my urologist that perhaps I should seek a second option, and to try radiations, chemotherapis or cancer drugs. He said no to all my requests. As I left his office, I was questioning myself whether or not I had been seeing the right clinician: if I had Stage 4 Prostate Cancer with metasis in my nearby organs and bones, how could a simple surgery be able to eradicate all these cancers that had spread through out my my body?
After the surgery, I immediately experience all the side effects of Radical Prostatomy: namely, impotence, urinary incontince that has been unstoppable for almost 5 and half years now, my penis shrank to half of its previous length, and I only found out recently that I had been infertile right after the surgery and didn’t even know about it My wife left me with our three kids there has been no sexual intimacies after the surgery. I was plugged into deep depression, and lost my job at the big accounting firm. All these that had happened were because of a simple PSA screening. I don’t know if I ever had prostate cancer because I was asymptomatic, but dying of prostate cancer would be much easier to deal with than what I have been going through since the Radical Prostatomy – It has completely ruined my LIFE!!!
Soon most biopsies will be performed by Radiologists and Urologists will lose the gatekeeper function.
Radiation Oncologists are the most knowledgeable specialists in the management of cancer and they should be returned to their rightful role as the gatekeeper of all cancer management.
The Learning/ Informatics Machine is growing exponentially …. we will be , should be consulting Watson/ Deep Blue as we do a PSA test, or Pi Rads score , or individual opinions.
Thanks for all the interesting discussion – no wonder patients can be bewildered! While almost everyone in medicine is well-motivated, we can certainly be biased by the tools we have access to, and profit from. Surgeons and Cancer Services generally collaborate as a matter of course for conditions like breast cancer, which might require all of: surgery, chemotherapy, radiotherapy and hormonal or specific receptor therapy.
In my view, there is a risk in various specialties reducing the amount of team collaboration as physicians, for example, develop procedural skills. So, where the Cardiologist previously managed patients medically to the full possible extent, then referred them to the cardiac surgeon, most now refer their own patients to themselves for invasive testing and intervetion through stenting – which is undeniably lucrative. Gastroenterologists now do many of their own invasive procedures.
We all know that old saying that, to someone whose only tool is a hammer, every problem to be solved looks like a nail.
It would be great if men with prostate cancer had easy access to a “panel” of clinicians who could advise on the person’s individual situation, without specialty bias. Perhaps the primary team could be coordinated by the Oncologist or GP, who makes multiple referrals and collates opinions to present to, and discuss with, the patient. The Urologist could contribute their surgical skills and opinion, and the Radiation Oncologist their specialty skills and opinion, on an equal basis.
Thanks Mark. Firstly you are quite correct that higher Gleason score cancers have a worse prognosis and median survival. It is just that we have not proven that radical intervention definitely alters this natural history.
Second, as the head of the ACS, Otis Brawley, has written and as we have written, the ERSPC is seriously flawed because of a large imbalance in ADT monotherapy as primary treatment given to equivalent risk patients on the screening and control arms. Until the authors release their mortality data, which is easy to do and which we have been requesting for 8 years, no conclusions can be reached. Our call for an independent review of the ERSPC data in BMJ in 2016 was cited and supported recently by Pinsky et al in NEJM.
Ian, we must be reading different data ! I have papers that clearly show that men , with low grade cancers, and low Gleeson scores, have minimal risk of dying ,during 20 years of follow up; yet men with high- grade Prostate cancers ( Gleeson scores 8-10 ), have a high probability of dying, within 10 years of diagnosis. PSA testing is essential for early diagnosis, and the Biopsy is of importance to grade the cancer. The European study, which is by far the largest study on Prostate cancer screening, does show a significant reduction in deaths from Prostate cancer, for men, who had PSA screening compared with controls.
Thanks Henry. It would be highly unusual and very unlikely that an 83yo man would have ADT (androgen deprivation therapy) via castration for asymptomatic prostate cancer. Are you sure he didn’t have symptomatic locally advanced or symptomatic metastatic disease? ADT may have increased his risk of cardiovascular disease and earlier cardiac death too.
“Personally, I would never operate on a patient if I thought it was against their best interests, and I’m sure that’s the case with all my urology colleagues. I think all of us who are reasonable, whether radiation oncologists or urologists, are working together to promote multidisciplinary care. And I don’t think the vocal criticisms of one specialty group over another are particularly helpful.”
” I’m sure” and “all” are a dangerous combination. The professor seems to concede that, by switching from “all” his colleagues, to the reasonable, in the next sentence.
Criticisms of one group are not “over”, they are “of”. They are extremely helpful in analysing patterns of practice, as the radiotherapy advice seems to suggest. Of course from analysis must flow dialogue and possible clarification, or even change.
Five years ago in Brisbane, at the age of 83, my brother was castrated as the first line of treatment for recently diagnosed PC. PSA was elevated but I don’t know the Gleeson score ( if it was done ).
PSA failed to respond to castration so he then had radiotherapy.
Radiotherapy was successful, as per PSA, and there were no subsequent adverse effects or complications.
He subsequently died of cardiac failure earlier this year at the age of 88.
My presumption now, as well as at the time, is that no treatment intervention was necessary, particularly the castration surgery.
Any comments, particularly in regard to the surgical castration ? I thought this treatment was abandoned many years ago.
Well said Sandra. You are a courageous voice of reason in an area where radiation oncologists have often felt unable to express their private thoughts in public.
Mark, despite what we want to believe, the data is the data. Gleason score has not been a reliable predictor of benefit for radical intervention.
Unfortunately the data still shows that virtually the same group of men will still die of prostate cancer on the same day as they would have at a median of 82, irrespective of how many PSA tests, biopsies and radical treatments we dispense to large groups of men in their forties, fifties and sixties.
Associate Professor Ian Haines, is opposed to both PSA screening and Surgery for early Prostate cancer. How do you hope to make a diagnosis of early Prostate cancer without PSA testing ! Most Urologists agree that active surveillance is the preferred option for early Prostate cancer- this implies regular PSA testing to monitor the progress of the disease; this is part of the surveillance protocol. PSA testing is very helpful in both diagnosing and monitoring Prostate cancer. However, it is the Biopsy that determines the aggressiveness of the disease ( the Gleeson score ) that will help determine the best management i.e are we dealing early non- aggressive disease, or more aggressive disease. I believe that PSA testing is a very useful test in detecting Prostate cancer but it is the Gleeson score that will determine the management.
As to the argument , what is the better treatment ; Prostatectomy or Radiation, for those patients needing treatment- I tend to reflect on the treatments my patients have had. I’ve seen some awful complications in patients who have had Radiotherapy yet most patients seem to do remarkably well following Prostatectomy.
It’s important to be clear: this is not a ‘turf war’ though that’s a popular way for journalists to pitch it. It is about men with prostate cancer being fully informed and involved in their own treatment decisions as the many sensible comments above support. Of course, doctors of all types don’t want to deliberately hurt their patients – but this is different than been consciously or subconsciously biased towards their own treatment in a way that influences patient care and cuts off options for men. How come prostate cancer continues to have the poorest record of MDM/MDT care for all cancer types if there is no problem – even in your own state Prof. Sengupta?
Men needing treatment for prostate cancer need to talk to a urologist and a radiation oncologist in nearly every case before they decide on treatment. Full stop. Why is it so hard for some people to say this? Urologists in powerful positions need to show leadership on this point (for instance in this article) or else how can their less well-informed or less ethical colleagues follow in their footsteps?
What sort of poll is this which asks two different questions but allows only one answer?
As a PC patient and a retired doctor allow me some observations-
* Results of trials being reported now cannot devalue actions taken years ago.
*Many patients look at the results of trials. So many trials are criticised it is no wonder that patients become bewildered.
* Some of the decisions relating to PC are determined by value judgments. One such example is the decision about the initial testing with a PSA test. Patients need to be involved in the decision making process.
*All the men in the support groups I know always recommend that a newly diagnosed patient should see both a surgeon and a radiation oncologist.
I have seen a patient who had metastatic prostatic cancer who have had radical postatectomies.
I frequently see complications of both prostatic biopsy and the radical prostatectomies.
Avoid unnecessary treatments at all costs.
Interestingly the person who developed the PSA recommends against using it for routine screening
Patients should discuss their options with their G.P.s
The problem with RCT is they are blinkered. They mostly demand more questions than give answers. Like John says, seek more opinions and hopefully you will find the best solution. Surgeons can be just as prejudiced as anyone else.
I am now 19 months post definitive irradiation for a T3b prostatic carcinoma associated with a PSA of 19. My PSA is now < 0.02. As a medical practitioner I was able to seek advice initially from 3 different Urologists. The first helpfully performed a trans-urethral prostatectomy to relieve my retention but did not identify malignancy. His reluctance to arrange a post -op MRI study lead me to my second Urologist who then confirmed the extent of the growth but stated it was inoperable and radiation would be of no use. My third Urologist confirmed I should also consult the Oncologist whose advice he always sought in cases such as mine This helpful and very professional advice has , i believe, extended my life. My advice to my Urological colleagues is read all the literature on this subject
Patients can’t make informed choices if they don’t hear both sides. They want to know the evidence.
With a huge investment in robotics, the incentive is to justify the investment. The driving force of this is the hospital.