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Clinical review of nmCRPC: Key trials and endpoints


Prof. Steven Joniau provides an overview of nmCRPC and highlights of the SPARTAN, PROSPER and ARAMIS trials including the recent overall survival update and discusses the safety and quality of life data.


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Hello, my name is Steven Joniau, and I’m a urologist at the university hospitals in Leuven Belgium.


My main focus in clinical work and in research as well, is prostate cancer, and I’m happy to share with you today some highlights regarding the treatment of non-metastatic CRPC. We’re going to talk about the new data on overall survival, also on some comparison of side effects of these drugs and quality of life issues and then finish off with the main messages in the conclusion.


Developments in non-metastatic Castration Resistant Prostate Cancer


Well, what about new developments in non-metastatic CRPC? First of all, I’m talking about high risk non-metastatic CRPC, that is a specific subgroup of all patients with non-metastatic CRPC, defined by a PSA doubling time less than 10 months, and that’s very important because that is the area where all the three drugs: apalutamide, enzalutamide and darolutamide were tested; in the SPARTAN, PROSPER and ARAMIS trials.




Now what’s new? Well, we already knew MFS, metastasis free survival, was prolonged in those trials, with about two years. But scepticism remains. Why? Because, well clinicians said maybe you delayed time until you see mets, but, is overall survival also prolonged? Well that’s, that’s the new stuff. Because in 2020 at the ASCO and ESMO meetings, the overall survival results of the three trials: the SPARTAN, PROSPER, ARAMIS trials were presented, and all three trials showed significant prolongation of overall survival.


Wow, ok. Now all of a sudden, this becomes really interesting for clinicians, and for patients. But there’s still a question we have to ask ourselves. If we put everything in balance, the benefits, on one hand MFS and overall survival benefits, if we put on the other hand, side effects and quality of life, into the balance, how does it weigh off, one against the other? Well I can tell you that the quality of life measurements in those three trials showed that quality of life, even though patients in the treatment arms received very intensive androgen receptor targeted agents, that the quality of life was actually maintained in all these patients.


There was no difference between the treatment group and placebo groups, in all three trials, and if there was a difference, then usually the benefits was in favour of the treatment arm. So that’s good news for patients, because besides survival benefit, they also have maintained quality of life.


Side-Effect Profiles


Lastly, side-effect profiles, that’s a little bit of a different story because, it’s not so easy to compare, head to head those three trials, why is that? Because, for instance in the SPARTAN trial, adverse events were collected, in the beginning of the trial every 4 weeks; in the two other trials every 16 weeks, so that already, you know, creates a bit of an imbalance if you want to compare side effects.


Next to that, if you look at placebo arms in the three trials, you can clearly see that even though these patients were pretty similar, there were actually similar, they all received ADT, that side effect profiles were also different, and in my mind, the best way to correct for all this is to look at safety, at similar treatment exposure, and to balance out the treatment arm versus the placebo arm, regarding the side effects. If we do that, then we see that any side effects or any adverse events, is not very different in all three trials, comparing the placebo arm with the treatment arms.


That’s interesting; if you look at serious adverse events, exactly the same. There are however, some typical side effects related to the three different drugs. If you look at specific side effects we see much less falls, fractures, cognitive impairment in the ARAMIS trial, which was the darolutamide trial, vs we see more of that in both the SPARTAN trial with apalutamide and the PROSPER trial with enzalutamide. And also we see slightly more hypertension in the ENZA trial and we see more skin rash in the apalutamide trial.


New standards in the treatment of non-metastatic CRPC


So, what I take away from everything we’ve seen so far in these three trials is that we have three new standards in the treatment of non-metastatic CRPC in patients at high risk of running into problems. Why? Because we have MFS which is prolonged, we have overall survival which is significantly prolonged as well, we have quality of life which is maintained, and we have a side effect profile which, although slightly different between drugs, is very, very manageable in those patients. So for me, yes, these three drugs are now the new standard in the treatment of non-metastatic CRPC patients.


I thank you very much for listening. Hope you enjoyed it, stay tuned to the GU CONNECT website. Bye, see you soon.

Steven Joniau graduated in Urology in 2002 at the Catholic University of Leuven. In 2003, he was appointed full-time staff member at the Dept. of Urology, University Hospitals Leuven after a 1-year fellowship at the University Hospital of Wales, Cardiff, UK. In July 2012, he obtained his PhD in Medical Sciences entitled ‘High-risk localized prostate cancer: the role of surgery and the development of clinical outcome prediction models’. In 2013, he was appointed Assistant Professor at the Catholic University of Leuven. His principal field of interest is the management of urological cancers. He is heavily involved in uro- oncological surgery and the multidisciplinary approach of pelvic cancers. He also leads numerous research projects at the University Hospitals Leuven, which focus on lymph node staging in prostate cancer, surgical management and biomarker development of high-risk prostate cancer, the natural history of premalignant lesions of the prostate, chemoprevention of prostate and bladder cancer, minimally invasive treatment of renal cell cancer and prostate cancer, etc. Steven Joniau is scientific secretary of the BVU (Belgische Vereniging voor Urologie), he is past- chairman of the Renal Cell Carcinoma Group of the Young Academic Urologists Working Party of the EAU, he is member of the EAU Guideline Panel on Prostate Cancer and the SIOG Prostate Cancer Guideline Panel. He is also a member of several international scientific societies: EAU, SIU (Société Internationale d’Urologie), SIOG (International Society of Geriatric Oncology) and EORTC GUCG (European Organisation for Research and Treatment of Cancer, Genito-Urinary Cancers Group). He is appointed Associate Editor of ‘The Journal of OncoPathology’. He is Editorial Advisory Board member of ‘The European Journal of Surgical oncology’, Editorial Board member of ‘The Open Prostate Cancer Journal’, ‘Archivo Italiano di Urologia e Andrologia’, ‘The Central European Journal of Urology’ and International Scientific Board member of ‘Archivos Españoles de Urología’. Steven Joniau has received several international awards, of which the First prize of the Urological Challenge Session, received at the 2010 European Urology Forum in Davos, Switzerland, the Crystal Matula Award 2011, received at the 2011 EAU annual congress in Vienna, Austria and the biannual Orion International Oncology Award 2011, received at the 2011 EAU annual congress in Vienna, Austria are the most prestigious. In the last 10 years, he has published >170 papers in peer-reviewed journals in the field of uro- oncology and minimally invasive surgery. He received the Prize for the Best Paper published on Clinical Research in the Urological Literature at the EAU annual congress in Stockholm. He authored several book chapters, he has been invited Faculty in over 85 international congresses and is a faculty member of the ESU (European School of Urology).
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