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Hello, and welcome to this podcast covering ‘Prostate cancer highlights from ASCO GU, ASCO and EAUN 2022’. I'm Dr Jason Alcorn and I am a nurse consultant for Uro-oncology and Andrology at the Mid Yorkshire Hospitals NHS trust in the UK. And I'm also a member of the GU Nurses CONNECT. Today I'm joined by fellow GU Nurses CONNECT member Jennifer Sutton.
Yes, thank you Jason. I'm Jennifer Sutton and I'm a registered nurse and the director of nursing and administration at Carolina Urologic Research Center in the United States. It's a pleasure to join you today.
So Jennifer I know you attended the ASCO GU and ASCO 2022 conference sessions. I'm interested to hear which data from these conferences, particularly caught your attention.
Yes, there was a lot of great presentations at both these conferences, but the first session that I would like to talk about is the ARASENS trial, which was presented at ASCO GU earlier this year by Dr Matthew Smith and looked at treatment intensification with triplet therapy in metastatic castrate sensitive prostate cancer patients.
ARASENS evaluated the effect of darolutamide in combination with ADT and docetaxel on overall survival in patients with mCSPC with a global, randomised, double-blind, placebo-controlled, phase 3 study. mCSPC patients were randomized one-to-one to darolutamide 600 milligrams twice daily plus ADT plus six cycles of docetaxel versus placebo twice daily plus ADT plus six cycles of docetaxel.
Darolutamide in combination with ADT and docetaxel significantly improved overall survival compared with ADT and docetaxel in patients with metastatic castrate sensitive prostate cancer. Darolutamide reduced the risk of death by 32.5 %. It also significantly improved key secondary endpoints including time to castration resistant prostate cancer, time to pain progression, time to first symptomatic skeletal event and time to first subsequent antineoplastic therapy. Darolutamide in combination with ADT and docetaxel should become a new standard of care for treatment of mCSPC.
It is also important to note that updated overall survival findings from ENZAMET were presented at ASCO, which revealed that enzalutamide added to testosterone suppression compared with an active comparator of a non-steroidal anti-androgen provided clinically meaningful improvements in overall survival for the combined overall cohort which persisted with an additional three years of follow up.
The benefits were more pronounced in patients with low volume disease and were also seen in the subgroup with M1, high volume mCSPC despite the relatively high survival with testosterone suppression, plus docetaxel plus a non-steroidal anti-androgen. Longer follow up has helped clarify the benefit for de Novo plus docetaxel.
Thanks for that overview Jennifer. Now I think about intensity intensifying therapy, I'm immediately considering whether there would be any additional toxicity for patients. Was any additional toxicity seen in the ARASENS trial.
Great question. Rates of adverse events were similar between the darolutamide and placebo groups, which means that the toxicity with ADT plus chemo does not notably change by adding darolutamide, making it a well-tolerated drug so it's good news for the patient. I experienced this first hand as we participated in the ARAMIS trial for nmCRPC and the ARASENS trial for mCSPC. It was exciting as a nurse, to be able to provide a drug to a patient without adding additional toxicity.
That's good news as hopefully, then we can actually see our patients tolerating the drug better and actually staying on treatment for longer. With that in mind I'm just thinking what additional patient education is required for these patients when they start drugs such as darolutamide?
Good point whenever you're talking about adding additional therapy that patient is going to question the additional toxicity so it's important for the nurse to educate the patients that although they're adding an additional therapy they're not necessarily increasing toxicity.
It's important for the patients to report any change in baseline but it's also important for the nurse to reassure the patient that data suggests that the drug does not have additional toxicity.
So we've seen the treatment landscape change significantly over the past seven years or so for mCSPC patients with treatment intensification with ADT and docetaxel from the CHAARTED and STAMPEDE trials and then also more recently from the use of ADT and ARI’s, including abiraterone, again in the STAMPEDE trial, but also the LATITUDE trial, apalutamide in the TITAN trial, but also enzalutamide in the ARCHES and ENZAMET trial. We've seen that the use of triple therapy from PEACE-1 which is the ADT plus docetaxel and abiraterone, but now also from the ARASENS trial as well.
So, if you think about the implications of this data for clinical practice, what are your thoughts on the triple therapy for patients? Should we be using it now and, if so, which patients would it benefit?
It's exciting to see the treatment landscape change significantly for mCSPC patients with ADT intensification with androgen receptor inhibitors and or docetaxel with the eight clinical trials you just mentioned.
Do all patients with mCSPC benefit from ADT intensification? Yes, these studies have shown that ADT alone is not sufficient treatment. We still don't know when we should use triplet therapy, which is ADT plus an ARI plus docetaxel. The value of docetaxel addition to an ARI is not known.
But data from ENZAMET, PEACE-1 and ARASENS is suggesting benefit in mCSPC de novo docetaxel populations. It's also important that the patient is engaged in the treatment decision making process.
So thanks for sharing your insights there Jennifer were there any other presentations that caught your attention?
Yes, so at the main ASCO conference, this year we saw a subgroup analysis of prior and concomitant treatment from the VISION trial which looked at lutetium PSMA in PSMA positive mCRPC patients.
But before we get into that let's review the term, theranostics it's a combination of the terms therapeutics and diagnostic. Theranostics is the term used to describe a combination of using one radioactive drug to identify or diagnose, and a second radioactive drug to deliver therapy to treat the tumours.
Prostate specific membrane antigen or PSMA is an emerging diagnostic and theranostic biomarker for prostate cancer detection and targeted radioligand therapy, as it is highly expressed in all types of prostate carcinomas.
The VISION study enrolled patients with mCRPC to lutetium PSMA with standard of care versus the standard of care, which in this study was largely a second exposure to androgen receptor pathway inhibitor, radiation and steroids. Lutetium PSMA prolonged overall survival. This analysis showed a survival benefit with lutetium PSMA regardless of prior treatment or concomitant standard of care chosen in PSMA positive mCRPC patients.
Prior to the VISION trial, TheraP had previously reported, which is a phase 2 trial which evaluated lutetium PSMA versus cabazitaxel in men with mCRPC after docetaxel.
Lutetium PSMA was more active than cabazitaxel, with relatively fewer grade 3/4 AEs and PSA progression free survival favouring lutetium PSMA.
It's exciting, because lutetium PSMA was approved by FDA this year, based on VISION trial results.
I agree Jennifer the radioligand therapy is a really exciting area, and I think it's really going to change the landscape of treatment for these patients.
It's great see that the US has got FDA approval. In the UK we've got an early access programme but we're still waiting for market authorisation to implement this in the health service, and I think that is a case in much of Europe at this present time.
Yes, and even though we have FDA approval here in the States it's still a challenge to get it across the country to be available for all patients. So it's going to be a work in progress for the world.
So Jason as a board member of the EAUN you had the opportunity to judge a number of posters at the recent EAUN Conference in Amsterdam, would you like to tell us about the ones that stood out for you.
Yeah thanks Jennifer and before I get into the 3 that I selected, I've got to say that it's really encouraging that we're actually seeing nurses take up research and actually look at their practice as well as developing areas of practice and treatment for patients, rather than it just be left to our medical colleagues to undertake and implement. So it was really good to have a large number of abstracts or posters to look at and to judge.
The pleasing thing is, over the years, the standard has really, really improved, which is good. So the 3 abstracts that I want to focus on the first one is entitled ‘Knowledge sharing, a practice development initiative to improve rehabilitation in prostate cancer patients’.
On the face of it, it seems very simple, in the knowledge sharing in that we would all take that as a given. This is a Danish study, by an author called Villumsen and they sought to understand if teams delivering cancer rehabilitation care, if those teams required updating with evidence-based guidelines, which again as I say, you would think is a given, but that is not the case in every country.
And they also sought to understand whether those teams need for knowledge, provided evidence and support. And in Denmark, it was quite clear in how they are structured in that these teams do not have access to the same sorts of knowledge or evidence base as their colleagues within what we would call secondary care or acute care, which is a hospital setting.
So it's a practice development rather than a research study and the author's what they did the methodology that they implemented was that they presented a questionnaire to physiotherapists, nurse specialists and occupational therapists at various points within a patient’s pathway.
And these were prior to and after an educational webinar; then again, four months later.
The webinar focused on aspects of cancer rehabilitation for patients. Now the results of the questionnaire found that participants easily understood the subjects in the webinar which we would all agree is a finding that we would find as a standard. However, what was interesting was that some of these teams actually changed their programmes and their approach to providing cancer rehabilitation based on that webinar. They felt more confident in delivering rehabilitation programmes, which would lead you to think that actually these pockets of teams were not getting the information or the knowledge that they're required to deliver the care or the rehabilitation to patients as we would think.
They also found that the evidence for exercise in patients with metastatic cancer and clinical expertise actually motivated the teams to provide more rehabilitation than what was asked for. And I think this highlights an area for nurses in clinical practice, that knowledge sharing within teams or from external sources is of paramount importance in delivering quality patient care.
This is one area where knowledge sharing in prostate cancer rehabilitation has proved to be correct. The evidence base for exercise programmes to improve patient care is there and is needed to provide that care to patients.
Yeah that's very interesting, knowledge sharing, as you said you'd think is a given and also having access to evidence-based guidelines you would think is a given as well, so it's interesting to know that there's facilities and I'm sure there's facilities all around the world, including the United States that are not having the access to the knowledge sharing and the evidence-based practice it's exciting to know that they this facility did change practice after they learned about the new evidence-based guidelines and they were able to implement it, that's exciting news.
So the next poster that I found interesting was ‘The establishment of a standardised patient involving PRO intervention for patients with prostate cancer treated with active surveillance’. I found this interesting because it's a technology based programmes, which is the way that we're all going now is using much more technology than we have done previously again, this is another Danish practice development study by someone called Ostergaard and her team were investigating the implementation of an App to standardise care and increase patient involvement in active surveillance for prostate cancer.
So it's interesting and really good that they were looking at ways of using this App to actually standardise the care and get that participation involvement. So they undertook a series of interviews with medical doctors and specialist nurses and they used semi structured interviews gathering insights and perspectives.
But also they undertook a focus group with patients to understand what they thought was missing from the current standard follow up of care. So with this knowledge from both sides, what they did was they then built an App and produced this App with a patient education Programme.
Patient involvement, as we all know, is of paramount importance when we developing programmes for patients to get their involvement and their insights into their care. So they ensured that throughout this programme in the testing of the App they involved patients wherever possible.
The results of the programme and the App have shown that patients were actually much more enthusiastic about the care and they were able to utilise this new technology much better and they felt that patients were more involved and they actually reported fewer concerns.
So this has the potential to allow nurses in their everyday practice to focus on the patients who are struggling with their care, with the diagnoses but also allows the clinical staff to direct time and resources to where and when the patient needs it, thus allowing timely interventions.
While this is going on, we can permit patients who have no concerns and no worries that they can actually continue to live their lives as normal as possible.
Yeah that is super cool engaging the patient is so important, and I do think you're right as nurses, we need to make sure we're focusing on that and patients having access to technology, where they can share their concerns, what a step forward. Now with these patients, were they a younger population? I know that I live in Myrtle beach, South Carolina and we have a retired elderly population and so access to technology is something that can intimidate them, so, as you said, these patients were enthusiastic maybe they're just more used to technology, are using it, or were some of them new to it?
Interestingly enough, the spread of ages was right across the board and I think what the key to it was the education programme. Before they went on to use the App they actually taught patients, how to use it. They actually spoke about the care so again, it was education, it was giving them that information which enabled much more success in using the App.
You're so right and patient education is key so having the time to sit down with the patient and provide that education and them being able to take it home and review the information through technology that's awesome.
So the final poster that I selected, which was a ‘ProsCApp mobile application helps improve the quality of supportive care in patients with prostate cancer’. Again it's another technology based App, but this time it's more focused on clinical staff, rather than actual patients and what Charalambous and his team said is that it’s something becoming more prevalent in our care and the treatment of patients with which we've just alluded to.
They recognise that supportive care is a person centered approach which we would agree with and this relies on meeting informational, spiritual, emotional, social, or physical needs during diagnosis, treatment or the follow up phases, including the issues of health promotion and prevention, survivorship and palliation and bereavement.
So their study looked at how nurses utilise a mobile application to improve care. Again, it was a qualitative study using unstructured interviews with nurses but they only had a single selection criteria, which was nurses that use the App for more than one month. They undertook a content analysis, which was to interpret and code the data.
The themes that they unearthed, were that nurses were able to care for patients holistically, they were being more proactive in addressing needs and provide a more consistent care. Also, the users found that the main obstacle in integrating a mobile technology or application into practice was the lack of guideline utilisation and management support, and I think this actually came from the fact that the App was used over multiple countries and not just in a single country.
For nursing practice the findings highlighted the value that mobile applications as tools can provide supportive care to prostate cancer patients. As this App has shown, when undertaking a clinical consultation they can be minimally obstructive when providing care and actually enhance the nursing efforts to meet patient's needs.
Yes, once again, as you said, technology is going to become very normal as we move forward through time and having Apps on our phones is necessity now. It's awesome that these nurses have a prostate cancer App.
I know that the prostate cancer foundation, they have an App that patients can download.
So I think that yeah the development of more Apps like this would only help the patient and improve the quality of care for the patient.
Exactly, and I think, as we improve the care for patient, yeah, it makes our jobs, our roles much easier to provide that care in using and embracing technology.
Well, thank you Jennifer for a very interesting discussion, and I think that we could actually have gone much longer than we have done about these interesting topics.
We certainly covered a variety of presentations. So, in summary we've heard practice changing results from the ARASENS trial highlighting the importance of early treatment intensification and also the benefits of radioligand therapy such as lutetium PSMA for our patients.
We've also discussed the importance of knowledge sharing, education and technology to support our patients through their prostate cancer journey.
So thank you once again, and thank you to our listeners, and we hope you found the discussion useful as much as we did.