Managing oesophagogastric cancer in general practice
Bobby Henry: Hi everyone, and welcome to the first national webinar series for the RACGP running in conjunction with the Cancer Council of the University of Melbourne and the Victorian state Government. My name is Bobby Henry, I am the national business development manager for the RACGP. That’s me, you should be able to see me on the screen now. I am here in order to present the joint presentation of managing prostate cancer in general practice. A couple of things first…
Bobby Henry: So, firstly I would like to recognize the traditional custodians of the land and sea on which we live and work and we pay our respects to the Elders past and present.
Bobby Henry: Any of the attendees, and we have a large number of attendees in today’s webinar who are online at the moment. If you need to access your control panel, you are able to type us questions throughout the presentation today. You need to open up your control panel and then down the bottom right hand side there is a chat option and you will be able to send us as the organiser’s chat request and send through any questions that you have for the presentation today. The two presenters today will be presenting for roughly about an hour. We are happy to take questions during that time; however, there is an allocated half an hour at the end of the webinar today for asking any questions and I will be carparking a number of questions to ask the two presenters later on in the webinar.
Bobby Henry: So, at the moment, all of you as attendees are muted for this webinar. Because of the large number of attendees unfortunately we can’t have conversations happening back and forth, so I am going to leave it up to the two presenters and it’s my great pleasure to welcome our two presenters today.
Bobby Henry: So, we have in the room here with me is Professor John Emery. He is a professor of primary care research at the University of Melbourne. He is a primary care researcher and the education lead for Victorian Comprehension Cancer Centre. He is an NHMRC practitioner fellow, he is the director of Cancer Australia Primary Care Collaborative Cancer Clinical Trials Group and a visiting research fellow at the Department of Public Health & Primary Care. He studied at the University of Cambridge and he was previously the Professor of General Practice and the head of School of Primary Aboriginal and Rural Health Care at the University of Western Australia. He also has worked for the Cancer Council on the implementation of their Optimal Cancer Care Pathways in Victoria. So, welcome John, thanks for being here today. And online, and hopefully he is there…. Declan, are you there? At the moment Declan is ... here he comes. Hi Declan. Thanks for joining us Declan. So, online visiting us from England at the moment. He is Declan Murphy, a consultant in Urology and a Directory of Genito Urology and Oncology at the Peter MacCallum Cancer Centre here in Melbourne. He is an Honorary Clinical Associate Professor at the University of Melbourne and he is an internationally recognized key opinion leader in GU Oncology, prostate cancer in particular. Declan has published hundreds of papers and has been the chief investigator on grants worth many millions of dollars. He holds senior editorial position at a British Journal of Urology International, European Urology, Nature Review Urology and Prostate Cancer and Prostatic Disease and is on the board of reviewers for many other journals. So, thank you for being with us Declan and thanks for taking time out of your holidays to join us and help present this very obviously topical conversation. We have over 800 attendees online viewing us right now, so that’s an incredibly well-attended webinar and obviously something that general practice in Australia is really interested in hearing about. And you can hear us okay over there Declan?
Declan Murphy: Yes Bobby, I can hear you, can you hear me?
Bobby: Yeah, we are all good over here as well. Thanks very much for joining us. I am going to hand over … we are going to shut our webcams down now and we are only going to present the presentation. So, you should just see the presentation from this point on. I am going to hand over to John.
John: Thanks very much Bobby, we’ll just place the webcam down first.
John: So, these are our core learning outcomes for this evening, so _____ obviously around prevention and the early detection of prostate cancer and considerations around initial investigations and referral on for people with suspected prostate cancer. We are of course going to talk quite a lot about prostate cancer testing and screening and we are going to introduce you to an evidence based decision aid that we hope might be useful in your discussions around PSA testing. And then go onto talk a bit about referral pathways and then Declan will discuss in more detail some of the treatment options for men with particularly early prostate cancer.
John: So, we are going to begin with an initial polling question. This work that we are presenting today relates to the Optimal Care Pathways and we are interested in understanding your current awareness of the Optimal Care Pathways. So, I think we are just getting the first polling question up now.
Bobby: So, at the moment John, let’s go up and …. No one said excellent, 6% say very good, 30% and a third of third of third say good, fair and poor at the moment.
John: Okay. We will just allow a few more moments, for people to complete the poll.
Bobby: That’s a pretty good representation.
John: Okay, so…I think that not so surprisingly we see that awareness around the Optimal Care Pathways is still not very high, so I am going to… we are closing the poll now….
John: So, some background about what the Optimal Care Pathways are, they are national program that was launched last year and they are really about trying to define what best evidence care should look like for multiple different cancers at a national level. So they are there to define what a good standard of care should be. There are 15 Optimal Care Pathways that have now been published, developed initially by Cancer Council Victoria and are now being disseminated at a national program, and have been adopted as a national program by the Federal Government. The idea is really to define through prevention, screening, early detection, diagnosis and then treatment and through palliative care, what the optimal pathway and the optimal standard of care should look like. They emphasize the importance of communication, particularly between general practice and other healthcare providers and key transition points for both patients and carers, and they are really aiming to raise the overall standard of care and identify where the gaps in current care exist. So, the background to explaining what we are talking about with the optimal care pathways is that some of the work that we are presenting today is actually being funded through the Victorian government as part of a program within Victoria to implement the OCPs. I suspect across other states there are different projects also going on with specific focus around certain optimal care pathways as well.
John: We are talking about prostate cancer as one of two cancers that Cancer Council Victoria and the University of Melbourne have been developing resources for recently and we are going to be sharing some of those resources with you during this webinar.
John: These are some of the key messages that we will be covering, of course issues around the incidence of cancer and survival rates, but recognising that a significant proportion of men diagnosed and treated for prostate cancer have ongoing problems with their quality of life relating to treatment side-effects. We aim to discuss certain risk factors _____ of risk, how to support men to make informed decisions around PSA testing. We will talk a little bit about prostate cancer symptoms and their investigation and then go on to talk about referral and treatment options, in particular around active surveillance as a treatment option for early prostate cancer.
John: So, initially just some background statistics around prostate cancer in Australia. So, it is estimated that just over 17,000 men during 2018 will be diagnosed with the condition. That represents nearly a quarter of all new male cancer cases diagnosed this year. Around about three-and-a-half thousand men are expected to die with the condition. Again, that represents approximately 1 in 8 of all cancer deaths in Australia. So, although prostate cancer is seen as a relatively benign disease it is a major cause of cancer deaths in this country.
John: The reason of course that it is seen as a benign disease is that the vast majority of men, they actually live a long time and 95% of men will live at least five years after a prostate cancer diagnosis. That means there is a very large number of men living beyond the diagnosis and treatment for their prostate cancer, so there are now nearly 94,000 prostate cancer survivors, many of whom will live long term with their condition and with the consequences of their treatment.
John: In terms of just thinking about what some of the key risk factors are, age is the strongest risk factor. This diagram shows in the darker blue line how incidence of prostate care rises with age. The peak of course is actually in about 65 and that probably relates to the sort of incidence of prostate cancer testing, but you will see that mortality rises quite significantly with age, particularly increasing from the age of 70. And again, Declan might want to comment later on about how the trends in mortality and incidence relate to patterns of PSA testing.
John: The other important risk factor to consider is family history. We know that if you've had a first-degree relative, either a brother or a father and particularly if they were diagnosed before the age of 60 that that increases your risk of being diagnosed with prostate cancer as well. Ethnicity is another important factor, particularly black African men are at increased risk of prostate cancer in general, but also of more severe disease as well. There has been a large number of studies looking at various other risk factors including dietary factors and variable evidence around animal fat, dairy products and calcium, but none of these really allow us to identify really preventable components of prostate cancers. At the moment there is very little that can be done in terms of primary prevention for this disease. There are some specific genetic factors, and in particular people who carry mutation in BRCA 1 or 2, often these are normally thought about in the context of strong family histories of breast and ovarian cancer, but men who carry one of these mutations are at increased risk of prostate cancer as well as male breast cancer and a number of other cancers as well. And then Lynch syndrome formally known as hereditary nonpolyposis colon cancer, again has recently been shown to include prostate cancer as one of the cancers for which there is an increased risk while of course colorectal cancer being the most important cancer associated with that syndrome.
John: So, we have our next polling question. So, I want you to think about a man who is at average risk of prostate cancer, so no family history and after you have discussed with him he has chosen to have a prostate cancer screening.
John: So, these are the options, which one will you choose to offer him? We will just get the polling questions up for you now.
John: We will just give you a little bit longer to note. Okay we are going to close that off now.
John: So, we actually have a fairly even split across all four options. So, 14% of viewers would offer a DRE with a PSA with a cut off value of 3, about a third would offer a DRE with a PSA with a cut-off of 4, a quarter equally split between a PSA alone either with a cut-off of 3 or 4. I am going to come to what the true answer is as we discuss the next few slides.
John: But I think that’s an interesting reflection on the range of different tests that are being offered currently.
John: So, PSA testing and prostate cancer screening of course have been a controversial topic for some time, with different professional bodies providing different recommendations. In the context that, Cancer Council Australia and the Prostate Cancer Foundation of Australia were funded through the NHMRC to provide consensus guidelines based on the best evidence that exists to make key recommendations around PSA testing. And these were published just under two years ago and they wanted to provide clear rational that was underpinned by the evidence around PSA testing and provide clear implications for practice. So, I am going to talk through some of the key recommendations that are raised from that evidence.
John: One of the major reasons for why there has been so much controversy is because of slightly conflicting results of the two large PSA screening trials. This is the summary results from the US PLCO trial with results after 13 years of follow-up showing that there is no difference in prostate cancer mortality between those in the control and the intervention. Sorry, we were just getting rid of a message on the screen ….
John: So, the US trial there …. one of the major criticisms around the US trial were the high rates of PSA testing that actually occurred in the control subjects. There was a large degree of contamination which actually limited the power to identify a potentially positive result in this trial. In the European ERSPC trial, again this is data on prostate cancer mortality after 13 years of follow-up and you can see in this trial where there is much less contamination, much lower rates of PSA testing in the control group, but there is a 21% relative reduction in prostate cancer mortality and this was statistically significant. So, there we have two conflicting trials, very large trials, well-conducted trials, but with differing results. There have been Cochrane reviews as well that have summarized the evidence from these large trials as well as some smaller trials and the Cochrane evidence has suggested no difference, and again this is why there has been ongoing controversy.
John: The Cancer Council Australia consensus group though, reviewed all the evidence and in particular wanted to take greater weight of the evidence from the largest European trial which probably has the most robust trial findings. And these summarize these results both up to 11 years of followup and 13 years of followup, which again show a very consistent reduction in the risk of deaths from prostate cancer, and importantly looking at these numbers here, if you look at the number needed to be invited to avert one prostate cancer death then based on the 13-year followup you need to invite 781 men to avert one prostate cancer death, and you need to treat 27 men to avert one prostate cancer death. So, these are relatively large numbers needed to both invite and to prevent death, which again is part of the challenges of determining what is the best action for an individual man.
John: We will come onto a discussion around side effects of treatment as well in a moment.
John: So, this is the core recommendation that came from those guidelines, and so it didn't come out recommending all men should be tested. It said that all men should be offered the opportunity to have a discussion around the benefits and harms of PSA testing before making that decision. This is a very important recommendation in the sense that what we mustn’t be doing is adding a PSA test onto a battery of other blood tests without having a conversation with the man before that test is offered. We know historically that men have often had PSA tests without necessarily being aware of it until they have actually had the result of raised PSA and at that point, only then do they realise they have actually had PSA testing as part of, often added onto lipid tests and so on. Importantly the harms of PSA testing may outweigh the benefits particularly in men aged over 70, who have a shorter life expectancy and therefore less likely to be benefiting in terms of extended life. And then in terms of the specific testing that men at average risk should be offered. So, they recommend a PSA every two years from 50 to 69 and that testing should be a PSA only. I will come onto the issue of rectal examination a bit later, and the threshold is of 3ng/mL. So that threshold is lowered from what the previous before these guidelines were being used as a threshold for an abnormal test.
John: If you have a raised PSA then this needs to be followed up. If the range is between 3 and 5.5 then repeating the PSA between one and three months after that first abnormal result and including a free-to-total PSA ratio within that repeat test. If the repeat total PSA is above 5.5 then that’s a recommendation for referral to a urologist for further assessment and consideration of a prostate biopsy. If the range is between 3 and 5.5 then that’s where the free-to-total PSA comes in as additional information, and if that is below 25% again that increases the likelihood of a prostate cancer being present and again is an alternative indication for referral for further assessment by a urologist. So, importantly the key message there is that the initial cut-off is being reduced to 3ng/mL from what it used to be 4mg.
Bobby: John, let’s kind of jump in there. I have had a couple of questions from the audience about testing younger men, men in their 40s.
John: Yep. We are going to come over to that.
Bobby: Right. And the last one is, when should PSAs be repeated? How often? Every two years?
John: So, every two years for men at average risk assuming that obviously the test is below 3ng/mL.
Bobby: Thank you.
John: So, this is a decision aid that we have developed based on evidence from the national guidelines and also more recent evidence in relation to the uptake of active surveillance. So, if we imagine that we have a 1000 men who are offered and choose to have a PSA test, then of those, 165 will have a raised result and requiring referral for a biopsy. Of those 165 there will be 93 who are found not to have prostate cancer and 30 of those will require some form of healthcare or hospitalisation as a result of a side effect of the biopsy. So, even the prostate biopsy is not a risk-free procedure. Again, later on Declan might want to comment on different approaches to biopsy to reduce some of the compilations. So, previously it used to be transrectal and there is growing use of perineal biopsy instead. So, that means that of the 165 men, 72 will be diagnosed with prostate cancer following that biopsy. Of those 72, 25 will have a slow-growing cancer, so a Gleason grade 6 prostate cancer. They are the group who will increasingly be offered active surveillance, which we will go into in more detail later, and of those 18 will choose no immediate treatment and during a 12-month follow-up period those 18 under active surveillance, two of those 18 will actually choose to end active surveillance and go on to have some form of treatment, either surgery or radiation therapy. There are also the other 54 who will choose to have immediate treatment. So, in the end there will be 56 people who choose eventually to have surgery or radiation therapy to treat their prostate cancer. Of those, 23 will experience ongoing side-effects of that treatment at 12 months either erectile dysfunction, urinary incontinence or bowel problems and again the frequency of those side-effects there is according to the type of treatment that is chosen, particularly, so surgery versus radiation therapy will alter the frequency of the different complications. Two men will avoid presenting with metastatic prostate cancer as a result of testing. So, that’s part of the benefit. So, of the 1000 men there will be two who if they hadn’t been screened will have presented with metastatic disease. And a further one to two deaths will be avoided from prostate cancer. So, this is why it is a complicated decision because there are various different consequences that may arise from having PSA testing. We think that this is a decision that may help part of those discussions and so the highlight is some of the uncertainties around for an individual man who is considering PSA testing, that it is not a straightforward decision to make.
Bobby: John, a very common question that’s coming through right now is if the initial PSA is tested and it is greater than 3 what’s the timeframe for retesting for that _____?
John: Yeah, so, between one to three months.
Bobby: One to three months.
John: You would repeat the test.
John: So, the next issue is the role of the digital rectal exam. So, obviously historically the rectal exam has been part of the prostate screening and so we are noting that that was actually probably contributed to some men choosing not to have the test because of the nature of rectal exams. The consensus guidelines looks at the issue of the role of DRE particularly in primary care practice and the relative benefits in terms of sensitivity to pick up early prostate cancer. It’s not a very good test, and so the decision was made that actually you can get the same degree of sensitivity and specificity, so reducing false positives, if you don't do the rectal exam, but you lower the PSA threshold, so as we were saying before, the PSA threshold used to be 4 in combination with a DRE. By eliminating the need for a DRE and lowering the threshold to a PSA of 3, you get the same balance between sensitivity and _________, so, detection of early cancers vs false positives. So, that was the rationale for excluding the DRE as part of the assessment in asymptomatic men, and that’s the important point. So, this is in the context of men who don't have symptoms, but who want to be tested for prostate cancer.
John: So, we have another polling question and this relates to Barry, who mentions that his brother had prostate cancer diagnosed at the age of 56.
John: So, at what age should you start to be having a discussion around PSA testing with Barry?
John: So, we have again a ….. a spread of recommendations from the audience, so 17% suggests from the age of 40, 27% from the age of 45, and half of you suggest that he should be offered testing from the age of 50 as you would a man at average risk and then 5% from the age of 55.
John: So again, this was another aspect of the national guidelines that was considered and this table looks at the mortality rate from prostate cancer by your relative risk of developing prostate cancer. So, here we have your … if you are at average risk and you are aged 50 this is your mortality rate from prostate cancer. If you then compare that to somebody who has a relative risk of between 2.5 and 3 and this equates to having one first-degree relative with prostate cancer, so, a brother or a father, then your mortality rate is equivalent at the age of 45 to an average man at age 50. If instead you actually have a very strong family history, say for example, a brother and a father with prostate cancer, which puts you at relative risk of 9, then your mortality rate is equivalent to a man of age 50 when you are at 40 and this has been the basis of the recommendations of when you might start to offer PSA testing according to the level of family history.
John: So, if you have just a father or a brother which diagnosed with prostate cancer, which gives you a relative risk of about 3 then the recommendation is again that you should have a discussion around PSA testing every two years from the age of 45 to 69. If you have a much stronger family history, say a father and two or more brothers, then the recommendation is that you should commence that discussion even earlier at the age of 40. Again, within the guidelines it was recommended that men with family history probably have slightly more to gain from PSA testing than men who aren't at increased risk, but also that that testing should be brought forward earlier according to how significant their family history was.
John: I want to just go back before you talk about symptoms. I note there was a question more generally about testing in the 40s.
Bobby: That’s right.
John: We don’t actually have a slide on that, but I did want to bring this up at this point. Because also in these guidelines there is a discussion around the role of using the PSA test at about 45, not as a screening test to detect cancer at that point, but actually as a way of assessing somebody’s future risk of developing prostate cancer and determining when they might want to commence regular PSA testing.
Bobby: That’s what most of the questions have been about as well John.
John: Okay good.
John: So, this is where it gets slightly more complicated. So, there may be some men in their 40s who are concerned about their prostate cancer risk, not necessarily of being diagnosed at that point, but it might help inform how often they would be tested subsequently. The challenge with interpreting the results of PSA testing in your 40s is that there are age-specific ranges of a PSA test, and so the guidelines go into quite some detail about the cut-off thresholds according to the age of the man in his 40s and when they would then commence PSA testing regularly. So, for example, they assume that laboratories will be reporting the median and the 75th and the 90th centile ranges for PSA tests, because the frequency with which you might offer a man at 45, subsequent testing depends on whether they lie below or above the median PSA test for a man of that age. So, it is more complicated, it does rely on pathology labs providing that information and I don’t think across the nation that is happening yet. So, it’s a difficult guideline to implement unless you specifically request the age-specific ranges in their 40s for that lab to be able to interpret the result.
Bobby: Does it change depending on when the father or the brother were diagnosed with prostate cancer?
John: So, the risk does go up slightly more if your brother or father was diagnosed before the age of 60 so compared to if your father was diagnosed in his 80s.
Bobby: So, would you start testing a little earlier?
John: No, so, the guideline doesn’t go into that level of detail, but it does suggest that you may be more likely to benefit if your family history was of a relative before the age of 60, but you would still go on these testing recommendations of starting at 45 if you just have one affected first-degree relative.
Bobby: Great. Thank you.
John: So, we are going to move on just briefly to talk about symptomatic prostate cancer. So, obviously one of the issues with prostate cancer testing is that the majority of early prostate cancer is asymptomatic. The table on the right actually is a way of thinking about how symptoms predict the presence of prostate cancer. And so, although there is this broad notion that prostate cancer is usually asymptomatic in early disease, these data actually show that there are a number of important symptoms and physical signs that do help predict the risk of undiagnosed prostate cancer. And so, the way this table is read, if you look at the top row, these are the numbers of what are called the positive predictive value, so the likelihood that somebody for example with frequency or urgency has an underlying prostate cancer. So, 2.2% of men with frequency and urgency in primary care would actually have an underlying prostate cancer and this is compared to men without symptoms. Obviously, in red, the most important predictor not surprisingly is a malignant feeling prostate on rectal examination. So, that is on its own, so 12% of men in primary care who are felt to have a malignant feeling prostate on rectal exam will actually have prostate cancer. Again, it’s still not very predictive, but that is the most significant predictor. Again, it highlights why the rectal exam still has relevance in primary care, but mainly in the context of men with lower urinary tract symptoms. The combinations of symptoms are how you read the rest of the table, say for example, somebody with nocturia and hesitancy as a combination of those two symptoms have about a 2.8% chance of having an underlying prostate cancer. So, this is a way of thinking about symptoms and signs as they predict the underlying risk of a diagnosis and although there has been some recent discussion about whether men with lower urinary tract symptoms should have a PSA. I think this actually is a justification for, A: doing obviously a rectal examination, but also men with lower urinary tract symptoms, a PSA is part of the assessment of those urinary tract symptoms. Of course, there are other things like U&E and MSU and glucose and so on.
John: And then finally, in my part of the presentation I just wanted to flag some of the relevant resources that are highlighted through the Optimal Care Pathways that are provided by cancer councils around the nation to support both prevention and also for supportive care in patients with prostate cancer. The optimal care pathways if you are interested, these are available as a quick reference guide for GPs for all 15 cancers if you Google Optimal Care Pathways, it will take you immediately to the site and there are now brief reference guides around the key aspects across the whole delivery of care, and a further more detailed version as well that you may wish to look at. The Cancer Council also offer the Live Lighter program, which is a way of supporting both healthy eating and weight reduction and of course in each state there is a Quitline www.quit.org.au and the 13 78 48 phone number which you can refer patients who are interested in quitting smoking. While smoking itself isn’t a risk factor for prostate cancer it is of course an important risk factor for many other conditions and we should continue to be offering regular quit advice. I am going to hand over now to Declan unless there are any very specific questions that we needed to cover at this point.
Bobby: I don’t think so, they were more around very broad questions around, if other family members had other BRCA gene findings, should we do prostate cancer tests?
John: Yeah, so, that’s an important question I guess, so, if you know that somebody is from a family with BRCA1 or 2 mutation the man will also be offered predictive testing because of the risk of other cancers that are not female specific. And of course the risk of passing on thatmutation to the next generation as well. And so, they would normally be seen at a familial cancer service and be given a fairly tailored advice around what sort of cancer surveillance test they should be offered. PSA would be part of that.
Bobby: And, in terms of an indigenous population, is it still a relevant pathway and testing process?
John: It is, yes. There are some indigenous-specific Optimal Care Pathways that have been developed, but I don’t think the risks of prostate cancer vary that much in indigenous populations and so the advice that have been given for indigenous patients is just the same as for nonindigenous Australians as well.
Bobby: Okay. Great. Thanks John, that covers most of the broad questions that are asked, so…
John: Great. Okay.
Bobby: So, Declan, we hope you are still with us from afar.
Declan: Yes, good evening John, can you hear me?
Declan: I have just put my webcam on for a second there to say hello, so… for those who joined late, I am dialing in from a beautiful forest in the southwest of England that John knows I believe. I am up here on holidays with my family, but I had committed to this webinar and I am happy to be distracted away from running around the forest with the kids and cycling to enjoy this excellent webinar and I thank you again for the invitation John and Bobby for having me on board to support this excellent venture. So, I have been tasked to discuss two specific areas in localised prostate cancer. I am going to focus most of the next few minutes on active surveillance and then I will speak briefly at the end about active treatment and how we help patients navigate the management choices that patients have. Next slide please, John.
Declan: I have no specific disclosures. Next slide please for this topic.
Declan: So, regarding active surveillance I am going to talk through these four topics briefly. Next slide, please.
Declan: And the first is just to give you a little bit of a background, I suppose it is worth reminding ourselves of the definition or the main aim of active surveillance, and it is the avoidance of intervention and obviously therefore the side effects of intervention for localised prostate cancer without at the same time compromising the likelihood that a patient with known prostate cancer confined to the prostate will progress to metastasis and death from prostate cancer. So, it is trying to balance these two goals of course making sure that a known prostate cancer is not going to progress or lead to a poor outcome for a patient, and on the same time trying to avoid treatment-related side-effects and these are the principles of active surveillance. Next slide please John.
Declan: And I think I will summarise it straightaway, next slide please. By saying that utilisation around the world, in Australia I would say in particular has been very good. Next slide please.
Declan: What we have seen over the past 10 years is a great increase in the utilisation of active surveillance in most areas of the world, in particular Europe and Australia. Next slide please.
Declan: It has been much more sluggish in the United States where there has been a lot of overtreatment of prostate cancer historically, and we wrote a piece about this in Nature Reviews Urology a couple of years ago and what you see on these barographs here are men with localised prostate cancer in the US. In the first set of columns on the left we have men with low-risk prostate cancer, so these are the active surveillance groups in particular, and each of these graphs here shows you a time period going from 1990 on the left up to more contemporary times on the right. And in the blue is active surveillance. So, you can see in the earlier time periods very very low use of active surveillance in low-risk men. These are men who do not need active treatment of the order of only 6% or 7% of men having active surveillance, and then finally we have seen within the past 10 years utilisation has increased up to about 40% and this is based on a very large well-regarded dataset called CaPSURE, which is not just academic _____ it’s also community urologists in the US. Next slide please.
Declan: A second point from these graphs that I highlight here with these bars is that in purple we see radical prostatectomy, so we see a great reduction in the use of radical prostatectomy for low-risk men in the US and a great increase in the use of radical prostatectomy for higher risk cancers, which is not so much the focus of our talk today. Next slide please.
Declan: So, what about here in Australia, he says from England. We have published a lot about active surveillance in the past few years and one of our richest datasets has been the Victorian prostate cancer registry. This is a very well set up registry that’s been running for almost 10 years in Victoria now and with the support of funding from the Movember Foundation it has now spread to be a registry running across all of Australia and New Zealand. It’s a very rich dataset for patterns of care and also quality of care for men with prostate cancer in Australia. So one of our MD students did a thesis on this in 2015 published in the BJUI and what we showed back then was about a 1000 men we have on surveillance in Victoria and we showed that in the low risk category, I haven’t defined that, but broadly that’s men with PSAs below 10 or Gleason 6 prostate cancer as we now call it Grade Group 1 prostate cancer, so these ones that don’t look terribly nasty on a biopsy, and at that time we saw that more than a third of men in Victoria were been managed with active surveillance in this setting. And we also showed a small number of men with slightly higher risk prostate cancer, what we call intermediate risk prostate cancer. These are men with a slightly higher PSA or a Gleason score that’s a little bit higher like for example a Gleason score of 7, Grade Group 2. And so these figures when you compare them with others around the world show a good, I would say good utilisation of active surveillance. But we will also look at this group of low risk men and say, well, look we could do better, surely there are more men in this low-risk category that can safely be offered surveillance, and I will come back to that in a second. I also point out here that at the one-year time period in men in Victoria on active surveillance, overall about 17% of patients will change from surveillance into intervention. So, this is an important consideration for us when we counsel men about surveillance. Because they want to know, okay, well, number one, what does surveillance involve and what’s the protocol. I will come back to that in a second. And number 2, what’s my likelihood of needing treatment. And I should say the presumption and the background as I stated at the outset is that these men are not going to die of prostate cancer. In other words if they do need to have intervention it will be in a timely fashion such that their overall prostate cancer specific survival will be the same as if they had treatment at the get-to. And that’s the figure, about one in five men will be reclassified to slightly higher risk cancer at the one-year period, which by the way is mostly driven by a biopsy because most men will have a followup biopsy about 12 months from their time of diagnosis. And the other 80-plus percent of men will have a favorable result on the biopsy and will stay on surveillance, and if they get past that that one-year biopsy by the way and don’t have a reclassification to higher risk disease they really are in a very favourable group and we don’t normally re-biopsy them for a couple of years beyond that time point. Next slide please John.
Declan: We have updated this data just in the past few months and in this paper published in the ANZ Journal of Surgery just a few weeks ago, we have now looked at a much larger group of patients and also a much more recent group of patients from the Victorian registry. So, these are very large numbers by international standards in peer review data, over 3000 men on surveillance now, and we see that the proportion of the low-risk patients has now reached 56% and it is rising, I have seen in our current data. So, I think now Australia is really one of the better performers around the world in the way in which conditions have embraced active surveillance as a valid strategy for men. And for GPs out there, I think this is important for us to consider this if a man is being referred in for investigation and if he does end up being diagnosed with prostate cancer, remember that a very significant proportion of those men nowadays will not be offered active treatment, and therefore will not be exposed to the treatment-related side-effects at least in the short-term presuming their cancer behaves itself than you would have seen in the past, even on the infographic that John showed earlier. Next slide please.
Declan: And these are my quick slides about data, because patients want to know is it okay to be on surveillance. Next slide please.
Declan: And yes is the answer. The Victorian registry is not mature enough yet to show long-term, like 15-year outcome because we haven’t been collecting the data long enough, and as you know it takes many years for a low-risk prostate cancer to become significant from a cancer death point of view, but we have seen very good data from Canada where this whole active surveillance concept was created 15 years ago and we see you know very very high rates of cancer-specific survival in this population. And even those few men who have died who started surveillance 15 years ago actually are men that nowadays we probably wouldn’t put on surveillance because we know a lot more about these cancers, patients with intermediate risk cancer for example. So, I think this is what I said to patients. I think provided we select patients carefully at the start and provided patients and clinicians adhere with active surveillance protocols, then the likelihood of patients dying from prostate cancer is down to the very very small percent figures, and of course a huge percent of patients will benefit overall by avoiding those treatment related side effects that we are also familiar with. Next slide please John.
Declan: So, my first set of take home messages. Yes, I think it’s important to accept that active surveillance is now very widely utilised for low risk localised prostate cancer approaching 60% in patients in Australia. Even in the US where there’s been a lot of overtreatment we see improvement in the utilisation of active surveillance in these patients, and our data from Australia shows that we are among the most proactive in the world for embracing this as a strategy. The long-term safety data is good and I think following from John’s earlier excellent overview of screening data I think that the overdiagnosis that we saw in those screening studies has been mitigated a little bit by reducing the overtreatment harm associated with widespread PSA testing. So, we accept that still, and we will come onto MRI scanning in a moment but there is still a lot of overdiagnosis of prostate cancer in screen populations, but it has been mitigated to a significant extent by the reduction in overtreatment of patients due to the utilisation of active surveillance. Next slide please John.
Declan: So, what we’ll discuss next is just a quick example. This for us is a chip shot in patient selection, easy decision, 68-year-old PSAs in the favourable range, PSA density which is the ratio of PSA to prostate volume, it’s an important risk stratifier for us, is favourable, T1c means we can’t feel it, and no family history and a normal MRI. The image on your screen there is what we get used to nowadays. We do a very large amount of MRI scanning in Australia and this is a beautiful normal-looking prostate on MRI. Let me tell you that if we have a 68-year-old with a PSA of 4 who gets referred in to us, the first thing that patient will be offered nowadays is an MRI scan, not a biopsy, and then that’s important John when we consider the infographic that we currently use that describes that patient flow from a 1000 odd patients and so on downwards. If you are referring a 165 of those 1000 patients as we saw on the infographic they won’t be having a biopsy. And this is a very significant change in practice in Australia because we use MRI routinely for patients in this setting. The majority of cases actually are now rebatable when we refer for an MRI, so patients aren’t even having to fund the 400-odd dollars it used to cost everybody. Since the 1st of July the rebate has come in so when we refer most patients, they will get an MRI under PBS rebatable conditions. And if a patient of mine has an MRI that looks like the one you see on your screen, I can tell you he certainly will not be having a biopsy because we accept that MRI is a strong predictor of clinically significant outcomes, but this refers to a case in that previous paradigm and this patient did go on to have a biopsy. What he has is low-volume low-grade prostate cancer, and he is a chip shot for us, very straightforward, that patient will be well managed on active surveillance and is likely to do very well indeed. But as I say the reality is this patient nowadays probably would not even be diagnosed with prostate cancer. In my practice he would be sent away with a normal MRI scan and we would just keep an eye on his PSA findings. Next slide please.
Declan: So, next just a few practical tips about how do we do surveillance. This may be a question GPs from the audience ….
Bobby: Sorry, I am just going to …. Declan can I just jump in for a sec sorry.
Bobby: I have had a couple of questions from the audience here about the MRI… and they have a lot of questions actually, and they are mainly around, can GPs refer patients for MRI?
Declan: Yes. But unfortunately the current rebate is limited to urologists and radiation oncologists. That’s just the best deal we could get with Canberra at the time Bobby, so unfortunately urologists are the gatekeepers for getting a rebatable MRI. But you know, there are many GPs on this webinar who will have or currently still referred directly for MRI because they are aware that it’s an important tool, but it will cost your patient about $400 depending on where you are.
Bobby: Thanks Declan, that answered a lot of people’s questions.
John: Declan, can I just ask in a follow up question around MRI. Is there a lot of variation in how well MRI of the prostate is reported and is it good to find out how the radiologist who does this who does this regularly.
Declan: Yes, that is important John because MRI of the prostate is a complex investigation, it’s a multi-parametric investigation which means that it is not just a straight T2 image. It involves diffusion weighted imaging and dynamic contrast-enhanced imaging and also we prefer that it is done on more powerful magnets like 3 Tesla magnets. 1.5 Tesla magnets are fine for knees and hips and all that, but we much prefer having higher power magnets and multi-parametric settings. So, one thing is the technology and the software, but the second is the interpretation and undoubtedly there is better concordance between expert radiologist than there are between radiologists who don't do a lot of prostate MR and so we tend to prefer a few centres where we know those radiologists are coming into our MDT meetings and they are seeing the results of any subsequent biopsies. So, the nice thing about good MDTs nowadays is on one screen there will be the results of a biopsy or a prostatectomy and on the other screen the radiologist will be looking back at the MRI scan to see did he or she get it right first time around, and I think therefore that’s why certain settings will provide more accurate interpretation of them and that’s the bottom line. So, for me around Melbourne I really only refer to three centres you know and that’s what I say to my patients if I am either funding it myself or I am taking advice to have an MRI scan, I want to make sure I get a very good scan that’s going to be correctly interpreted. Are you happy with that Bobby?
John: That’s right, keep going.
Bobby: Thank you, keep going Declan. Declan, a couple of other things just before you keep going.
Everyone is loving the bird sounds in the background (laughing). So, thanks for being where you are.
Declan: Thank you.
Bobby: Okay, you can continue now.
Declan: Great. Next slide please.
Declan: So, how do we do it? Very briefly, I’ve got three slides here that just show you a bunch of tables and I don’t want you to get too bogged down in it, but it’s very well described how to do active surveillance. Next slide please.
Declan: This is a paper we wrote in 2015 summarising various protocols you can see here, different centres around the world and this is about selection criteria. How do you select patients for surveillance. So, you can see, broadly speaking, people prefer if the PSA is less than 10. If you go across the table you will see that Gleason 6, GS is Gleason score, of 6 is what’s included in all these protocols and nowadays we call that grade group 1 cancer. There has been some changes in pathology, but broadly speaking you know low-grade cancer. Next slide please, John.
Declan: This one summarises the progression criteria. So, this is once we have made on surveillance, we tend to do a PSA every six months or so and then we do tend to repeat the biopsy and the MRI scan at the one-year time point. And as I showed you earlier that’s important because you call out about 17 or 20% of men whose cancer has changed, so these are men who were well ______ at the start but they are the one in five whose cancer will actually be growing and transforming and it is still in plenty of time. If we make that finding a year later those men will do very well if they are offered treatment. And the other 80% will not change. What you see on this slide are just some messages about changes of the PSA or changes in the Gleason score, changes in the volume of cancer, in other words the number of biopsies, I will come back to that in a second with a summary slide. Next slide please.
Declan: And I think we have also looked at the difference in regularity of PSA testings and biopsies in the various series around the world. Well, I tell you, in brief, in our practice we used to do PSAs every three or four months because that’s what many of those series on your screen list, but now we do it much less frequently. I think PSA and rectal examination are the least useful tools we use for monitoring men on surveillance and the most important tools are doing an MRI scan and a biopsy at intervals that we can discuss, but I remind you again we tend to do that at one year following diagnosis or certainly between 12 and 18 months and then we stretch it out because if your patient is okay to stay on surveillance at the one-year mark then they are very very unlikely to change significantly over the following years, that's our experience. So, therefore we can de-intensify the surveillance protocols and do that next MRI or biopsy two or three years later with a few interval PSAs just so we can stay in touch with the patient. Next slide please.
Declan: So, overall that’s the summary. All these protocols tend to restrict the selection criteria for low-risk men. So, Gleason 6 is you know in the old days, we now call that grade group 1 cancer. In other words it doesn’t look terrible on a biopsy of these low-grade well-formed cells. PSA broadly speaking below 10, but we allow PSAs to go higher if it is still grade group 1 cancer, and limited core involvement means that you know, not the whole prostate is full of low-grade cancer in a young patient that would raise some concerns for us, but we don’t restrict it to only one or two biopsies, we are happy for five or six or seven biopsies to be involved provided it’s all grade group 1. Next slide please.
Declan: So, what about MRI scanning, could we use MRI scans instead of a biopsy for example, because as you well know patients don’t like having biopsies. I am sure many people on the webinar have had a biopsy judging by the sheer numbers we have dialed in this evening, and they are not very pleasant, I will speak about transperineal biopsy in the second, but the big question for us is can we avoid biopsy in men who are on active surveillance. And that's where MRI has also shown to be of value. We now use MRI as I have mentioned at the outset trying to figure out who needs a biopsy in the first place and if the MRI is normal we will very often avoid a biopsy and accept the MRI as being a good triage too, but also for those men on surveillance the recent change in PBS rebates has allowed us to use MRI for these patients. They are allowed a biopsy once every three years or so after their initial diagnosis. What does that mean for us in practice? Yes, it means we do use MRI scans. If I have a patient who has been on active surveillance for three years and he is coming up on perhaps a biopsy, because he has not had one for two years, he may say to me, can I have an MRI scan instead and we will do that, and if the MRI scan is normal or unchanged from his initial MRI scan and if the patient is willing to accept that, an MRI scan is not quite as good as a biopsy for detecting microscopic changes of course then we will defer or avoid a biopsy. So, this is important. The data to guide that is lacking because Australia has probably been a bit ahead of the curve in the way we use MRI, but we don’t have really good data to say it’s safe or how often should we use one. But I will just again give you a positive message about that that we believe that one of the things that affects the number of biopsies we see in men on active surveillance is the fact that urologists are using MRI scans and putting a lot of faith or confidence into MRI scans to avoid having to biopsy these men. Next slide please.
Declan: So what about biopsy. We have been referring to this in John’s talk as well, and many of you will be familiar with the more recent introduction of transperineal biopsy instead of the old fashioned transrectal biopsy. Next slide please.
Declan: And of course, around the world transrectal biopsy has remained the standard for diagnosing men with prostate cancer and indeed monitoring men on surveillance, but it is associated with two main problems, number one obviously the risk of infection including very serious infection by putting the needle multiple times through the rectum is very significant, and number two, transrectal biopsy is also notorious for missing certain parts of the prostate, the anterior prostate, the apex of the prostate. In my personal practice I stopped doing transrectal biopsy 15 years ago because where I trained then in London at Guy’s Hospital we routinely used this approach transperineal. What you see in the top left of the picture is, in the bottom line there, there is an ultrasound probe going into the patient’s rectum and the black square you see is a template or a grid that’s lying over the patient's perineum. His legs are up in a lithotomy position and there is a biopsy needle being passed through the grid into the prostate, so that now is the way in which over 50% of prostate biopsies are being performed in Victoria across all centres, not just centres like Peter Mac where I work. So, this message has got out there that transperineal biopsy is safer because obviously the needle is going through skin and not through poo and, number 2, it's more accurate because you do reach those parts of the prostate that transrectal biopsy traditionally misses. It does require mostly a general anaesthetic, so it can be some resource limitations and you do need that special bit of kit I show you in the top left here, which is now though becoming much more commonly available due to more widespread enthusiasm for transperineal biopsy rather than transrectal. Next slide please.
Declan: But as I say, there has been a quite striking change in the utilisation. We have published a lot about transperineal biopsy over the years because it’s been our favourite approach for a very long time now, and we published that … you never say zero, but you have almost zero sepsis using a transperineal approach versus 5 or 6% using a transrectal approach. So that's very serious business considering the morbidity of sepsis in this setting. And also what we see with transperineal is as I said better accuracy. Next slide please.
Declan: We are picking up these low-grade cancers correctly. And we believe that transperineal biopsy you know should be mandatory if you are going to have a man on surveillance to make sure that you haven’t missed a more significant cancer anteriorly. Next slide please.
Declan: And that, as I have said, this data is not published yet but we recently presented it from the Victorian Prostate Cancer Registry, which by the way captures about 90% of all men diagnosed of prostate cancer in Victoria public or private, metro or regional, so we think this is a very good snapshot at almost population level and what we see, surprisingly to me is that about 50% of prostate biopsies are now being performed using a transperineal approach. Good news, good for your patients. They are much likely to have a safer biopsy and they are much more likely to have an accurate diagnosis. Next slide please.
Declan: So, take home messages. These protocols have shown you our very safe pathways. There’s some variability, but I have given you a rough idea of what we do. The use of MRI scanning and transperineal biopsy definitely improves safety and accuracy for risk stratification selecting these men. Next slide please.
Declan: And finally, about active surveillance, just some concerns. Next slide please.
Declan: A few months ago we published again from the Victorian Registry data about how we are using active surveillance in Victoria. And it received some media attention, here’s one of the things Norman Swan picked up on and that’s kind of a take home message from this paper that men with slow-growing prostate cancer aren't being properly monitored. So, I've given your all these favourable messages about active surveillance and now we're seeing that maybe we have swung the other way in and we have selected all these men out for active surveillance, but maybe we are not monitoring them correctly. Next slide please.
Declan: And what we showed again from Victorian Prostate Cancer Registry, 1600 men that we were watching on surveillance who had had at least three years of follow-up, so that’s why we have called the numbers, this is going back to 2015 or thereabouts, and we defined adequate surveillance with a pretty low bar, we said over a two-year period following diagnosis men should have at least three PSA tests and they should have at least one additional biopsy. Remember I have said that we tend to do a biopsy at the one-year mark because almost one in five men will have a change in their cancer. So, that additional biopsy is important, but for the purpose of this paper we extended it out to up to two years saying; look, okay, you don’t have to have it at one year, but may be 18 months or certainly within two years. Next slide please.
Declan: And what we found surprisingly to us is that 75% of men on surveillance in Victoria contemporary data, don't meet this pretty low bar and they are missing it because of both the biopsy and even the PSA, so they are not even getting the three PSA’s done. So, what’s happening? I mean one thing is MRI scanning probably is influencing the fact that so many men are not getting a biopsy at follow-up, but we couldn't measure it within the dataset we had for the earlier part of the registry. But, number 2, I think it’s failure is on behalf of clinicians like me as a urologist, it’s a failure on behalf of men I'm sure as well, not turning up or saying ah, I was told my cancer doesn’t need to be treated, that’ right, I am never going back to the doctor. My wife is off my case now, I have done the job and I am not going back there again. And the first biopsy was horrific so I don’t want to see that fellow again. So there may be a number of factors influencing it. Next slide please.
Declan: Either way I think we need to do a bit of work on this, maybe a better shared care model would work. I am interested in what John and you all think about that, because active surveillance tends to be driven from hospitals and from our rooms in the way we follow up patients. But it's very protocol driven. At Peter Mac, now we do it as a nurse-led thing and I think nurses are much better at driving these protocols than specialists. And also we need to get men better involved and whether we develop interventions or apps that are going to prompt them to be treated or whatever. I think it’s important that we do some work to get these utilisation levels up above the current level of only 25% having adequate surveillance. Next slide please.
Declan: I only have a couple of more slides left, but I am going to give you a polling question now and this is to the GP audience, saying, would you be comfortable managing active surveillance patients as part of a shared care pathway? So, if we as the secondary care providers were scheduling a biopsy or arranging an MRI scan with a rebate from time to time. Would GP's or nurses in general practice be happy managing patients, and we have just asked for a yes or a no. Yes, would you be happy if there was an agreed protocol to look after these patients or, no, you think that this is a business for doctors or for specialists, because these are active cancer patients who haven’t been treated and maybe the burden should rest with us. So, please click on one of these boxes and let us know what you think.
Declan: That’s fantastic. So, there you go…. That’s almost the answer John, isn’t it? I am really pleased to see that.
John: That’s great, that’s really interesting.
Declan: Yeah, isn’t it? And John you have obviously done a lot of work on shared care protocols in general practice and not on the surveillance side, maybe there is room here for _____ part 3. Next slide please.
Bobby: Sorry, Declan, I am just going to jump in there actually and just share a couple of quick questions because we don’t have much time left, and it’s about 10 minutes left for the whole webinar. So, the first one is, if we have had a lot of rural doctors, obviously here today or outside of metropolitan areas, where there is long wait times to get into a urologist, what could GPs be doing more of in terms of active surveillance for these patients who have higher levels of PSA or they have had a quasi diagnosis, what could they be doing?
Declan: Yes, it’s a practical problem isn’t it? Well, look, something we are very keen on is the whole role of telehealth for managing these patients, and a few accept that the old fashioned rectal examination has actually been dropped out of a lot of recommendations for early detection of prostate cancer including the consensus document that John referred to earlier. We can therefore advise patients using telehealth, and at Peter MacCallum Cancer Centre for example, where we don’t really have a catchment area, we look after patients from all over Australia, but we have a very nicely set-up telehealth service, we make it very easy for patients, there’s a team of people who ring the patient and say ‘do you have an iPad or do you have a computer, they just make it easy, it’s not a complicated gateway. So, you could, my first piece of advice is reach out to your nearest centre that will offer a tele-health and we will have a chat with the patient and ultimately that will allow them to be referred for an MRI scan. They don’t have to come all the way into Melbourne or down to Victoria, we can refer for an MRI scan in a valued centre nearby and they will get a rebated MRI scan. So, I think of telehealth as an opportunity if you would like to have your patient benefit from a little bit of specialist advice and a pathway to get an MRI scan, again because we can log in and see these scans from all over the place, I have been looking at scans this morning here in England from Melbourne. We can follow that up with a further telehealth to say, ‘your MRI scan looks normal, your PSA is only 5, would be happy to offer you just ongoing PSA surveillance, we recommend your GP checks it in a year, so remember that as an option. And I think now with MRI being rebatable, a really important bit of armamentarium for us in early detection is that we don't have patients languishing with higher PSA 7, 8, 9, 10, 12 without having an MRI scan you know. Because, if the MRI scan is abnormal it’s a different kettle of fish than the positive predictive value is high. These patients are likely to have a clinically significant cancer, not be suitable for surveillance et cetera. You know, they are the ones that John referred earlier towards the bottom of the graph that would benefit from a diagnosis and consideration of an intervention. So, MRI rules both ways, it helps avoid biopsy and by the way the figures are based on a big study in New England Journal of Medicine this year, the precision study. We showed that 30% of patients with a PSA of around 6 in this age group, in their 50s and 60s, 30% have a normal MRI and we don’t biopsy them, 70% have an abnormal MRI and then they will be considered for a targeted biopsy, we target what we see.
John: Right. Thanks Declan, that’s great.
Declan: I will go on the last two slides. The second topic which we weren’t going to focus much on because it deserves a whole thing in itself is what about the patients who do need active management, they have a diagnosis of what looks like a significant cancer. Because this whole argument about surgery and radiotherapy, gets brought up from time to time. Next slide please.
Declan: I am only going to show you one slide on it here, which is pointing out that both surgery, there is a robot on the left or radiation a linear accelerator are very reasonable options for a man to consider if he has a clinically significant cancer and has been advised that surveillance is not suitable and our strong view is that patients should be offered the opportunity to be counseled by both a surgeon and a radiation oncologist. Next slide please.
Declan: And I think that’s important that a second opinion gets offered and it's always of value, and even if the second opinion as to another surgeon or to a second radiation oncologist it always adds value as you know, and what I say to all of our patients coming in for second opinions is this doesn't mean you are changing team or we are changing the plan, you are just going to feel more informed, better informed about whichever decision you make, surgery or radiotherapy, and I think that’s important they don’t feel like I am cheating on my first specialist and I have gone to see the experts in the city or whatever. You know, it just means you are going to feel better informed about the decision you make and I think that's terribly important. We see lots of patients with regrets who said I was never offered a second opinion about radiation or about having surgery done in an expert centre et cetera. And that’s all I am going to say about this whole surgery versus radiation thing. Both are very very valid things to consider for a patient and patients should feel that an opportunity to discuss all options is made available to them. It’s never an emergency, needing to make a decision about surgery or radiation for prostate cancer, there’s always time to go and get another opinion and feel better informed and that's really all I want to say about that.
Declan: Next slide and final slide is I will promote …. Oh sorry, I do have a question. I routinely recommend …. this is a question for you… do you routinely recommend to your patients who have been diagnosed with localised prostate cancer that they seek a second opinion. Yes or no. And again, not always easy depending on what part of the country you are in or how you access your specialists, but I am interested in hearing what a big audience like we have online tonight think about this question.
Bobby: While we are waiting for that polling slide to come up, John _____
John: ____ that question.
Bobby: I think we have lost that question Declan.
Declan: Okay. That’s alright, we’ll go on. I mean I think it’s a good idea, Will you John make a comment on it, I mean you have a metropolitan academic practice, it’s not the same as everyone on the call tonight, but I think broadly speaking ….
John: I do think it’s an important thing to offer and for those in country there is still a great number of radiation oncology centres in rural areas as well. So, it’s certainly something that men should be offered at second opinion to, so they really do understand the different treatment options available to them. Obviously the first point of referral is usually going to be a urologist to make the initial diagnosis.
Declan: Yes, that's right. And finally there’s a nice study running at Peter Mac and patients can refer directly into this or GPs can refer directly in. It’s called the Navigate Study, it’s an NHMRC funded study for men, recently diagnosed with low-risk prostate cancer who may be struggling with their decision. Am I going to go on surveillance, I am nervous about it, maybe I’ll have surgery, maybe I’ll have some form of radiation blah blah blah. And this is a randomised trial, the controller arm gets access to the Prostate Cancer Foundation of Australia information resources which are very very good, and the intervention arm gets a very slick online portal that they can access from home on their iPad, it’s a decision aid developed by their psychologists at Peter Mac and Swinburne University by Penny Schofield and company with lots of videos and resources and you can ask questions along the way to say, okay, how much do you value your sexual function et cetera, et cetera. How much do you value living with prostate cancer versus having an intervention, and patients can self-refer into this by just googling Navigate Study at Peter Mac and access from anywhere in the country.
Declan: Next slide. That’s it I think for me John, I am aware we are running late on time and my final messages are on the screen and I am happy to get involved in the conversation.
John: Thank you very much Declan. We have I think about 5 minutes left for questions. So, what are the key ones that are coming up?
Bobby: I think, looking through all the questions from tonight I have been overwhelmed to be honest by the number of GPs who are asking questions about the pathway of testing patients. Should we be … an example that I have got here is, we take a PSA of a man and it’s less than 3 and then two years later we take it and it’s really close to 3 but it has increased, should we test sooner than two years or should we just wait for the next two years again?
John: So, again the issue is around PSA velocity which is sort of what this is getting to about, the rate of change of PSA, whereas also looked at as part of the consensus guidelines and the recommendation was that PSA velocity per se is no longer a particularly useful additional piece of information in the context of asymptomatic men and early detection of prostate cancer. So, the thresholds remain and you shouldn’t be accounting for small increases in the PSA. There is quite a large variation just on a day-to-day basis in your PSA level, and so that’s part of the ____, it can vary by 15% just day-to-day. So, you shouldn't take too much notice of small fluctuations in the PSA. The threshold is the most important thing, 3 _____.
Bobby: And is there a testing chart, like, is there a decision chart or testing chart or a protocol that GPs need access to?
John: In terms of the sort of summary of the guidelines…. So, if you go to the Cancer Council Australia Wikipedia page, there is a summary of what is obviously a very large document, but a summary statement about the key recommendations around the PSA testing guidelines.
Bobby: And last one about PSA, what about false negatives and false positives? How common are they? There were a few questions in there about one in five are false negatives, one in five are false positive…. How that translates to general practice?
John: Can we go back?
Bobby: We can.
Declan: So, while you are going back I will make a comment on that, and I think in this whole conversation about early detection of prostate cancer, we don’t use the word screening, we use early detection. We never rely on a single tool, for example, like PSA, we are always going to have a multivariable approach using, nowadays things like family history, rectal exam, PSA, MRI scanning very important in particular, and that helps mitigate the lack of sensitivity and specificity in PSA testing on its own.
John: Yeah. Sure. So, just going back to the decision aids, you can see of the 165 with a positive result there are 93 that are so called false positives, which talks to the false positive rate. The sensitivity is not presented here. Declan, just to remind me again there were lots of different cut-offs that were looked at and I am just trying to remember what the sensitivity is for that cut-off of 3.
Declan: It’s not great John, I can’t remember what it is for 3 because it varies of course depending on the age of the patient as well you know.
John: Yeah, that’s right.
Declan: Say, if it’s 3 in a 45-year-old it’s very different to a 68-year-old with some prostatitis, but I think that’s the message… the message is that PSA adds some value as an initial screening tool, it gets the patient to have a conversation. For example, the key trigger for example to have a biopsy is never determined by that on its own, we will always try and look for more justification to raise the area under the curve to say, yes you're more likely to have a significant diagnosis, therefore a biopsy is worth considering.
John: I think that is the point, while the rectal exam is not recommended in primary care, it is still certainly used by urologists as part of that assessment.
Bobby: Great. Thanks very much. Well, I think we have got 1 minute left. I am not sure there’s much else to cover honestly apart from thanking Declan who has obviously taken time out his holidays… and is showing us some nice greenery there… (laughter) thanks Declan. We love the birds too Declan.
Declan: Thank you John.
Bobby: And thanks very much John for coming in tonight, and thanks to the Cancer Council and the Victorian Government and Melbourne University as well for all of their input in this as well. It’s been a really … a lot of the feedback we are getting is a lot of thanks and a lot of gratitude for tonight’s webinar, so I think the GPs who are in attendance and those who watch it after are very grateful. Great.
John: Great. Thank you.
Bobby: Thanks very much.
Declan: Thank you.