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Trustworthy ‘Rapid Recommendations’ for Urology

BJU International has a longstanding track record of promoting the principles of evidence-based clinical practice to an international audience of urologists. Recent initiatives include the “guidelines of guidelines” series which appraises and contrasts clinical practice guidelines from different professional organizations on the same topic, for example on microscopic hematuria and non-muscle-invasive bladder cancer. It also co-publishes high quality, urology-relevant guidance by the UK’s National Institute for Health and Care Excellence (NICE), for example on the preoperative testing for elective surgery (https://www.bjuinternational.com/learning-2/urology-guidelines/nice-guidance-routine-preoperative-tests-elective-surgery/).

In collaboration with the MAGIC research and innovation program (www.magicproject.org), BJU International has published its first Rapid Recommendation guidance document on the use of medical expulsive therapy (MET) with alpha-blockers that was triggered by the recent rigorous Cochrane review on the same topic. Its purpose is to provide trustworthy, timely and practical guidance on this topic based on the entire body of evidence, given several recently published trials with contradictory findings. To develop this trustworthy guidance, an international team that included patients with a personal history of ureteral stones, general practitioners (GPs), emergency clinicians, urologists familiar with treating renal colic, epidemiologists, and methodologists followed a rigorous and transparent GRADE-based process in accordance with The National Academy of Science, Engineering and Medicine (formerly: Institute of Medicine) (https://www.nationalacademies.org/hmd/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx) standards for trustworthy guidelines. Panel member had no financial conflicts of interest and intellectual and professional conflicts of interests were described and carefully minimized. All meetings were conducted by web conference and the process was completed within 90 days of publication of the Cochrane review, which is co-published in BJU International in this same issue.

Initially pioneered in collaboration with the BMJ for questions of broader interest (https://www.bmj.com/rapid-recommendations) such as the use of corticosteroids for the treatment of a sore throat, this Rapid Recommendation breaks new ground for evidence-based guidance in urology, complementing the efforts by professional organizations such as the European Association of Urology (EAU) and American Urological Association (AUA). Rapid Recommendations stand out for their focus on patient-important outcomes, the use of an explicit and transparent process for moving from evidence to recommendations and its timely development process. Rapid Recommendations provide actionable guidance as well as information on the underlying evidence and supporting judgments that are summarized in an infographic that is easily understood by patients. The Rapid Recommendation on MET is intended to be the first of many to help inform patients, providers and policy-makers but also to seeks to provide a strong impetus for more trustworthy and useful guidelines in urology in general.

 

 

By Philipp Dahm1 2 and Per Olav Vandvik3 4 5

1 Minneapolis VA Medical Center, Urology Section, Minneapolis, MN, USA

2 University of Minnesota, Department of Urology, Minneapolis, MN, USA

3 Norwegian Institute of Public Health, Oslo, Norway

 

Disclosures:

Philipp Dahm serves as Coordinating Editor of Cochrane Urology, is member of the GRADE Working Group and served as a panel member of this Rapid Recommendation project

Per Olav Vandvik is member of the GRADE Working Group, is the leader of the MAGIC Foundation and BMJ Rapid Recommendations project and served as a panel member of this Rapid Recommendation project.

 

June 2018 – About the Cover

In the month that brings the BAUS annual meeting to Liverpool, the Article of the Month is a BAUS consensus document and so the cover features the sign for the Beatles Story museum in Liverpool.

The Museum contains recreations of The Casbah Coffee ClubThe Cavern Club and Abbey Road Studios among other historical Beatles items, such as John Lennon‘s spectacles, George Harrison‘s first guitar and a detailed history about the British Invasion and the solo careers of every Beatle.

 

 

 

© istock.com/ilbusca

 

The rise of the clinical entrepreneur

The NHS is the world’s largest, longest established, unified healthcare system and has been at the forefront of many pioneering medical innovations in its 70‐year history. These have included the intraocular lens, total hip replacement, the rod‐lens telescope, CT and MRI scanners, and the laryngeal mask. However, commercialisation of this technology has often been better achieved abroad.

Increasingly the latest greatest advances transforming our lives are originating directly from industry. Companies such as Amazon, Uber, Airbnb and Google are at the vanguard of this disruptive change. More and more, their innovative products and services are available directly to patients resulting in the disintermediation of doctors. This is heralding a new era – a personalised, empowered, democratised healthcare revolution.

Traditionally the NHS has supported clinicians who want to develop their career in academic, leadership or educational arenas but has not been as supportive of entrepreneurial clinicians.

If we are to deliver on the promise of the Five Year Forward View 1 and the patients of the NHS are to receive the first‐hand benefit of innovation, we need to equip our clinicians with the entrepreneurial skills, knowledge and experience that will enable them to understand and engage with this new world. We need to develop our clinicians, so that they have both entrepreneurial and intrapreneurial abilities.

This has already been recognised by trainee doctors. Increasingly juniors want to both deliver and improve healthcare. In the UK, >56% of trainees completing their Foundation Year 2 (FY2) do not continue straight into training posts and ~5% of trainees leave medicine each year to pursue other opportunities, many take up entrepreneurial positions. We are losing a generation of innovative, entrepreneurial clinicians with a skill set that would bring a new leadership capability to the NHS.

To address this NHS England in partnership with Health Education England has launched the Clinical Entrepreneur Programme 2. This national scale workforce development initiative allows clinicians to undertake entrepreneurial activity alongside their clinical work. It provides a coaching and mentoring scheme, less than full‐time training opportunities, advanced industry internships, customer matching, connections to funding and education, and networking events. In year one, 104 junior doctors were appointed, 50 start‐ups created, >£50 m in funding raised and a ‘brain drain’ was turned into a ‘brain gain’, with 34 doctors who had left medicine or were about to leave returning to work in the NHS. In year two, >220 clinicians have joined the programme. In future years we aim to include patients and citizens. By bringing all to the centre, as we re‐imagine and re‐design healthcare, will we have the best chance of getting it right.

The clinical entrepreneurs will ultimately number in the thousands and will act as ‘multilingual’ frontline agents for change, adoption, and spread of innovation throughout the NHS and beyond.

At the BAUS annual conference this year some of the current cohort will be pitching their start‐ups on the main stage. Why not join us and welcome the new generation of specialists in healthcare – the Clinical Entrepreneurs.

 

Tony Young
Innovation NHS England, Southend University HospitalInnovation Mid and South Essex STP, and School of Medicine, Anglia Ruskin University, Cambridge, UK

 

References

 

 

May 2018 – About the Cover

This issue’s Article of the Month, The Metabolic Syndrome & the Prostate, is from the University of Catania, Sicily, and the University of Florence.

The cover image shows a view across Sicily to Mount Etna, an active volcano lying above the convergent plate margin between the African Plate and the Eurasian Plate. At 10,922 ft high, it is the highest volcano in Europe and one of the most active volcanoes in the world, being in an almost constant state of activity.

 

© istock.com/Blueplace

 

The EAU 2018: Part 2

The 33rd annual congress of the European Association of Urology was held in Copenhagen. The weather outside was icy and further reason to stay inside and enjoy the modern and vast Bella Conference Center.  The EAU conference offers more each year to engage with all its members and age groups. Science, innovation and research is presented in interesting and current ways including live surgery, great social media interaction, game changing sessions, “EAU press release” video interviews and expert-guided poster tours.

Prostate cancer

The pre-conference emails and newsletters this year promised updates on prostate cancer detection and several different groups presented data. Artificial intelligence use is growing around the world with medical systems starting to show promise to match trained doctors in the future. A chinese team led by Dr. Chengwei Zhang, presented an artificial intelligence system which can diagnose and identify cancerous prostate samples with above 99% accuracy.

The “Radiomic TRUS” system, uses an artificial intelligence system to target transrectal ultrasound biopsies, allowing only 6 cores to be taken. The artificial intelligence imaging system is calibrated from radical prostatectomy specimens and can detect lesions from US not visible to the human eye. Their recent randomised controlled trial also showed better detection rate compared to TRUS guided 12 core to systematic biopsies and mpMRI assisted 12 core systematic biopsy in their study. However systematic biopsies may soon be obsolete according to the “Game Changing” plenary session and one of the conference highlights, came from the “PRECISION” trial from UCL, presented by Veeru Kasivisvanathan.

The results showed 71 (28%) of the 252 men in the MRI arm of the study avoided the need for a subsequent biopsy. Of those who needed a biopsy, the researchers detected clinically significant cancer in 95 (38%) of the 252 men, compared with 64 (26%) of the 248 men who received only the TRUS biopsy. This shows the benefit of using a mpMRI for ALL men with suspicion of prostate cancer. Men with a normal MRI (and no red flags) can avoid a biopsy. Men with a suspicious lesion on mpMRI can have targeted biopsies only (not systematic). Therefore using this protocol avoids unnecessary biopsies and when biopsies are taken, fewer cores are required.

(Read more in the PRECISION BJUI blog by Declan Murphy:-

Upper Tract Urothelial Cancer (UTUC)

The winner of the first prize for oncology was for the results of the POUT trial, a phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC), by Birtle A.J et al. They compared surveillance and adjuvant chemotherapy with gemcitabine-cisplatin,

post nephro-ureterectomy giving histologically confirmed pT2-T4 N0-3 M0 UTUC.

The chemotherapy arm showed improved metastasis-free survival in UTUC. Recruitment to the POUT trial was terminated early because of efficacy favouring the chemotherapy arm; follow up for overall survival continues. POUT is the largest randomised trial in UTUC and its results support the use of adjuvant chemotherapy as a new standard of care.

Transgender

The first accurate data to confirm that male to female transgender surgery can lead to a better life. The study shows that 80% of male-to-female patients perceived themselves as women post-surgery. However, the quality of life of transgender individuals is still significantly lower than the general population. Dr. Jochen Hess and his team from Germany, followed 156 patients for a median of more than 6 years after surgery. They developed and validated the new Essen Transgender Quality of Life Inventory, which is the first methodology to specifically consider transgender QoL. They found that there was a high overall level of satisfaction with the outcomes of surgery.

Stones

Since the SUSPEND trial showed no benefit to stone passage with medical expulsive therapy (MET) many centres have ceased tamsulosin for ureteric stone passage. However this has not been as widely adopted as might be expected, with opinion especially from USA feeling that larger stones may benefit from MET. A Chinese multicenter, randomised, double-blind, placebo-controlled has now shown benefit to ureteric stone passage greater than 5 mm. With the MIMIC study (a multicenter, International ureteric stone study) showing no benefit in MET for stone passage, the debate is set to continue! However for now the latest EAU guidelines recommends MET may be used to aid spontaneous passage for ureteric stones greater than 5 mm.

Renal Cell Carcinoma

Diagnostic renal biopsy for presumed renal cancer may increase in the future, with data from the Royal Free Hospital, London, showing benign results in 21.5% of biopsies, of which 98% avoided surgical intervention.

Social media

Twitter use overall seems to be slightly less than the last two years, with fewer Tweets and tweets/participants, but there were more active Tweeps and more impressions.

The 6th annual BJUI social media awards was held at the Crowne Plaza Hotel, close to the conference center. This fun and lighthearted event celebrated tech leaders, with two awards going to the EAU communications department for best conference and innovation. Stephen Fry was also acknowledged for raising awareness by tweeting on his personal prostate cancer journey.

(Read more https://www.bjuinternational.com/bjui-blog/6th-bjui-social-media-awards-2018/)

EAU guidelines are finding effective dissemination though social media.

 

Finally the top conference tweet went to BJUI editor Prokar Dasgupta for his thought provoking talk on robotic surgery in the developing world.

(read more https://eau18.uroweb.org/robotic-surgery-is-unnecessary-in-the-developing-world/?utm_source=EAU+News&utm_campaign=3d6dc39e7c-EAU_Newsletter_September9_14_2017&utm_medium=email&utm_term=0_019a710c04-3d6dc39e7c-106500857&ct=t(EAU_Newsletter_September9_14_2017)&goal=0_019a710c04-3d6dc39e7c-106500857)

This was a fantastically well organised conference with some great practice changing presentations, up next is EAU Barcelona in 2019. #EAU19 #Barcelona #SoMe

 

Nishant Bedi

Urology Registrar North London

@nishbedi

 

The EAU 2018: Part 1

An icy but (mostly) sunny Copenhagen welcomed the 14,000 delegates to the 33rd EAU annual conference. It is not uncommon for the first day of a conference to be a little subdued; this was certainly not the case in Copenhagen. On the first morning, the conference was already buzzing following a controversial presentation from Prof Prokar Dasgupta (@prokaruol). Despite a career in the vanguard of robotic urology, Prof Dasgupta advised the packed audience in the joint EAU- Société Internationale d’Urologie (SIU) session that, especially in the developing world, surgeons should “stop obsessing about technology… There are no differences in outcomes,” or even more succinctly……

This was just one of the many excellent talks at the joint EAU-SIU meeting. Despite Mr Wiklund’s excellent presentation on intracorporeal urinary diversion, Mr Gontero highlighted the lack of evidence to significant improvements to patients’ outcomes. Likewise, whilst Mr Declan Murphy (@declangmurphy) offered a spirited defence of SoMe highlighting its many benefits, Prof Jim Cato (@JimCatto) offered some words of caution to help avoid its pitfalls

Bladder Cancer

Following swiftly on from the EAU-SIU session, the bladder cancer debates offered a great succession of lectures from some of the leaders in the field. Alongside the growing importance of biomarkers, stratification of bladder cancers was a key topic. Prof Ashish Kamat (@UroDocAsh) spoke on importance of histological variants in NIMBC especially microvariant which is frequently BCG refractory.

On par with this was also the “Nightmare session on bladder cancer”. Excellently chaired by Mr T O’Brien , the session presented 3 challenging but not uncommon scenarios in the management of bladder cancer. It was then up to the expert surgeons to defend their decision to a leading medical negligence lawyer Bertie Leigh. Whilst the cross examination of Mr Hugh Mostafid (@ahmostafid)certainly didn’t look comfortable, the critical importance of getting muscle during TURBT was highlighted as well as fully and frankly informing patients.

Prostate Cancer

A highlight of the all-day session by Young Urologists Office (YOU) and European Society of Residents in Urology (ESRU) was the panel discussion on the management of intermediate prostate cancer highlighted. Despite a good pitch for focal therapy by Dr R Sanchez Salas (@RSanchez_Salas) as an experimental but very promising therapeutic approach, Mr Prasanna Sooriakumaran (@PSUrol)triumphantly defended radical treatment to win the round table discussion. Early subgroup analysis data from the ProTecT study showing significantly greater disease progression with active monitoring compared to radical treatment helped convince the audience.

Another key topic of the conference was the management of oligometastatic disease. During a plenary session arguments were presented for both systemic and local and metastasis targeted treatments. Dr De Meerleer gave an enjoyable explanation of the rational of treating the pokemets (sic) with the STOMP trials showing an 8-month median ADT-free survival benefit. However, Prof Mottet ended with the important reminder on the lack of data on PET PSMA to diagnose mets, treating the primary tumour or treating the metastasis. Whilst targeting mets offers an interesting approach it remains experimental without strong evidence.

The poster sessions offered a huge range of the latest research in prostate cancer. 19-year follow up results from the ERSPC Rotterdam offered strong evidence for the benefit of screening in prostate cancer with a 52% reduction in PCa associated mortality.

A corresponding poster from UC Irvine reported that following cessation of PSA screening, there was a rise in the incidence high risk disease from 6% to 19% albeit with a fall in grade group 1 disease. In a session on radical prostatectomy, a team from Leuven presented their data on the potentially unrealised dangers of Gleason 6, suggesting that patients with 3+3 with other high-risk features should be offered active treatment. But the twitter responses indicate that the audience were not fully convinced.

Andrology

The latest advances and hot topics in andrology was delivered to a packed room on the Saturday morning. The importance and dangers of lifestyle, epidemiology and increasing paternal ages were highlighted as important factors in accounting for the deteriorating semen quality seen in Europe.

Low intensity shockwave lithotripsy was also discussed. Whilst strong evidence supporting its use was presented, the importance of critically appraising all such data especially in ED was clear.

Despite being such a rare disease, a team from St Georges presented an interesting series on the management of squamous cell carcinoma of the anterior urethra with the advice to manage it in the same way as penile SCC.

Female and Functional Urology

The Section of Female and Functional Urology section meeting (ESFFU) addressed the important issue of female mesh with the clear recommendations that despite what is reported in the news mid-urethral slings are safe but only in the hands of appropriately trained surgeons.

BPH and Male LUTS

The conference provided an interesting showcase of the ever-growing arsenal now available to treat BPH. Alongside new 5-year data on urolift, more novel treatments such as the iTIND, Rezum, aqua ablation transurethral prostate evaporation and were presented together with transurethral enucleation with bipolar (TUEB). The advantages of HoLEP were also widely reported.

5 year data from a randomised study from Guanzhou of 240 demonstrated HoLEP resulting in significantly better long term efficacy compared to TURP. An interesting study from Miyazaki University, Japan, reported that an alternative technique of offered efficacious but safer and time efficient treatment. However, training especially during residency was highlighted as an issue that needs to be addressed. A excellent template for training was presented by Mr Kamran Ahmed with a comprehensive simulation training programme for endourology.

The Opening Ceremony

At the end of a busy first day in Copenhagen, the opening ceremony provided a great backdrop to celebrate the successes of the last year and a look to the future. An energetic drumming display officially opened the conference before the keynote speakers

Both EAU Secretary General Prof. Chris Chapple (@ProfCRChapple) and guest speak European Commissioner for Health and Food Safety, Prof. Vytenis Andriukaitis took the opportunity to urge greater collaboration between clinicians in Europe. European Reference Networks (ERNs) supported by the EAU offer the possibility of greater data collection and sharing expertise between urologists in Europe, hopefully something that the UK can continue to contribute to irrespective of what happens over the next few years. Amongst the many well deserved presentations, the prize for the most promising young urologist  (the crystal Matula named after the vessel for checking urine) was awarded to Selçuk Sılay (@SelcukSilay). Hashim Ahmed (@LondonProstate1) was awarded the very well deserved and very prestigious EAU Prostate Cancer Research Award.

But of course it is not just about what is going on in the halls and lecture rooms that makes the EAU so special, but also collaboration and friendship that it helps to foster amongst colleagues from around Europe and the wider world.

Nicholas Raison (@NicholasRaison)

April 2018 – About the Cover

This issue’s Article of the Month, Dietary Intervention to Prevent Clinical Progression in Prostate Cancer, is from San Diego, USA.

 

The cover shows the illuminated sign leading in to San Diego’s famous Gaslamp Quarter, a historic district on the National Register of Historic Places situated in the downtown of the city. It is is the epicentre of San Diego’s nightlife scene known for its theatres, art galleries, symphony halls, concert venues and museums.

 

 

 

 

 

©iStock.com/Mindy_Nicole_Photography

 

The 6th BJUI Social Media Awards (2018)

It’s hard to believe that we have been doing the BJUI Social Media Awards for six years now! I recall vividly our inaugural BJUi Social Media Awards in 2013, as the burgeoning social media community in urology gathered in the back of an Irish Bar in San Diego to celebrate all things social. At that time, many of us had only got to know each other through Twitter, and it was certainly fun going around the room putting faces with twitter handles for the first time. That spirit continues today as the “uro-twitterati” continues to grow, and the BJUi Awards, remain a fun annual focus for the social-active urology community to meet up in person.

We continue to alternate the Awards between the annual congresses of the American Urological Association (AUA) and of the European Association of Urology (EAU). Last year we descended on Boston, MA, to join the 15,000 or so other delegates attending the AUA Annual Meeting and to enjoy beautiful Boston. This year, we set sail for the #EAU18 Annual Meeting in the wonderful (but very cold) city of Copenhagen, along with over 13,000 delegates from 100 different countries.

On therefore to the Awards. These took place on Sunday 18th March 2018 in the Crowne Plaza Hotel, Copenhagen. Over 50 of the most prominent uro-twitterati from all over the world turned up to enjoy the hospitality of the BJUI and to hear who would be recognised in the 2018 BJUI Social Media Awards. Individuals and organisations were recognised across 12 categories including the top gong, The BJUI Social Media Award 2018, awarded to an individual, organization, innovation or initiative who has made an outstanding contribution to social media in urology in the preceding year. The 2013 Award was won by the outstanding Urology Match portal, followed in 2014 by Dr Stacy Loeb for her outstanding individual contributions, and in 2015 by the #UroJC twitter-based journal club. In 2017 we recognised the #ilooklikeaurologist social media campaign which we continue to promote. This year our Awards Committee consisted of members of the BJUI Editorial Board – Declan Murphy, Prokar Dasgupta, Matt Bultitude, Stacy Loeb, John Davis, as well as BJUI Managing Editor Scott Millar whose team in London drive the content across our social platforms. The Committee reviewed a huge range of materials and activity before reaching their final conclusions.

The full list of winners is as follows:

  • Most Read [email protected] – “Changing the LATITUDE of Treatment for High-Risk Hormone-Naïve Prostate Cancer: STAMPEDE-ing Towards Androgen Biosynthesis Inhibition”. Dr Zach Klaassen, Toronto, Canada

 

 

  • Most Social Paper – “Unprofessional content on Facebook accounts of US urology residency graduates”. Accepted by Dr Matt Bultitude on behalf of Dr Ann Gormley and colleagues

  • Best BJUI Tube Video – “The value of In-111 PSMA radioguided surgery for salvage lymphadenectomy in recurrent prostate cancer”. Dr Tobias Maurer, Munich, Germany.

  • Best Urology Conference for Social Media – awarded to the EAU for #EAU17 and #EAU18. Accepted by Prof Jim Catto on behalf of the EAU Communications Department.

  • Innovation Award EAU Communications Department, for their excellent Twitter strategy. Accepted by Prof Jim Catto onbehalf of Marc van Gurp and EAU colleagues

  • #UroJC AwardDr David Penson, Vanderbilt, USA. Accepted by Matt Bultitude

  • Best Social Media Campaign – awarded to The Urology Foundation, London, UK. In recognition of their use of social media to promote their advocacy, awareness and fundraising efforts in urology. Also an acknowledgement of twitter super-user Stephen Fry as a supporter of TUF, and his use of twitter to share his recent personal prostate cancer journey.

  • Most Social Trainee – Awarded to the “Bellclapper Podcasts”, featuring Jesse Ory, Kyle Lehman, Jeff Himmelman, from Dalhousie University, Canada.

  • The BJUI Social Media Award 2018 – awarded to @BURSTurology, in recognition of their use of social media to engage with other urology trainee and research groups around the world to drive collaborative research, including the #identify project. Collected by BURST Chair Veeru Kasi.

 

A number of the BJUI senior editorial team were also present to join the fun!

 

A special thanks to our outstanding BJUI team at BJUI in London, Scott Millar, Max Cobb and team, who manage our social media and website activity as well as the day-to-day running of our busy journal.

See you all in Chicago for #AUA19 where we will present the 7th BJUI Social Media Awards ceremony!

 

Declan Murphy

Peter MacCallum Cancer Centre, Melbourne, Australia

Associate Editor, BJUI

@declangmurphy

 

Video: Highlights from USANZ 2018

G’day! The 71st annual USANZ Congress, was held in Melbourne and had the biggest attendance on record for the past 6 years. The Urological Nurse’s congress: ANZUNS ran concurrently, encouraging multi disciplinary learning. An excellent and varied educational programme was masterminded by Declan Murphy, Nathan Lawrentschuk and their organising committee. Melbourne provided a great backdrop and soon felt like home with a rich and busy central business district, cultural and sporting venues, the Yarra river flowing past the conference centre, edgy graffiti and hipster coffee shops, plus too many shops, bars and restaurants to visit.

Sophie Rintoul-Hoad & Declan Murphy

 

PRECISION delivers on the PROMIS of mpMRI in early detection of prostate cancer

Today, Dr Veeru Kasi of University College London, presented the results of the PRECISION (PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not?) study in the “Game Changing” Plenary session at the #EAU18 Annual Meeting in Copenhagen. The accompanying paper was simultaneously published in the New England Journal of Medicine. And it is stunning! Everyone in the packed eURO auditorium knew they were witness to a practice-changing presentation, and the swift reaction on social media around the world confirms this.

 

Congratulations to Veeru (a second year urology resident in London), senior author Dr Caroline Moore, Prof Mark Emberton, and all the collaborators on this multicenter international trial. I had the great privilege to be the Discussant in the Plenary session so have been digesting this study in detail for the past few weeks.

Let me summarise the PRECISION study in brief. In this multicenter international study, 500 men with a suspicion of prostate cancer (mean age 64, median PSA 6.7), were randomised to receive a standard of care (SOC) diagnostic pathway (12 core TRUS biopsy), or an MRI directed pathway. In the MRI pathway, all patients had an MRI, and if the MRI was abnormal (72% of men), they had a targeted biopsy of the lesion(s) (with no systematic biopsy; ie only the abnormal lesion was biopsied). If the MRI was normal (28% of men), they did not have a biopsy, and continued on routine PSA surveillance. The primary outcome was detection rate of clinically significant cancer; and secondary outcomes included the detection rate of clinically insignificant cancer. In the standard of care arm, the detection rate of clinically significant cancer was 26%, and the detection rate of clinically insignificant cancer was 22%. In the MRI pathway, the detection rate of clinically significant cancer was 38%, and the detection rate of taking insignificant cancer was 9%. This is depicted below in one of my summary slides from the plenary discussion.

 

Therefore, despite the fact that over one quarter of men in the MRI pathway actually avoided a biopsy, the detection rate of clinically significant cancer was much greater in this arm (ie UNDER-diagnosis was reduced). Furthermore, the detection rate of the clinically insignificant cancer was much less (ie OVER-diagnosis was reduced). And all this with a median number of biopsy cores of only four, compared with 12 in the SOC arm. The reduction in core numbers along that too much less complications for these patients.

This looks like WIN-WIN all round!

 

And I truly believe that these findings should provoke an immediate change in our diagnostic pathway for early prostate cancer in two ways:

  1. All patients with a clinical suspicion of prostate cancer should be offered an MRI as part of their informed/shared decision making pathway
  2. All patients with an abnormality on their MRI scan should be offered be targeted biopsy alone.

The obvious concern of course, is the fate of those patients with a normal MRI (28% of patients), who despite a clinical suspicion of prostate cancer, did not have a biopsy. How many clinically significant cancers might we miss by not offering biopsy to those patients? Of course, we already have an idea of what we would find, as the PROMIS study also included extensive biopsy (transperienal mapping) for patients with a normal MRI.

In PROMIS, the negative predictive value of MRI for detecting any pattern 4 cancer is 76% ie up to 1 in 4 men will have some pattern 4 cancer on transperineal biopsy. However, no primary pattern 4 cancers were missed on MRI. This is something we have to digest. I think that we can accept missing some pattern 4 cancers in some men, provided the “routine follow up” is adequate. But we must also continue to use the other tools we have in our multivariable approach to early detection, and if there are red flags due to family history, palpable nodules, adverse PSA parameters (including PSA density), BRCA mutations, then there will clearly be a role for systematic biopsy in some of these men with normal MRI scans.

In my opinion, we now have enough evidence to fully embrace mpMRI in our approach to early detection of prostate cancer. Following on from the PROMIS study, published in the Lancet 2017, the PRECISION study provides us with the imprimatur to fully embed MRI in the assessment of men with a suspicion of prostate cancer. The era of blind random prostate biopsy is surely over, except perhaps in those patients in whom MRI is contra-indicated. The next challenge will be to create enough capacity and expertise to make this paradigm available to all.

Resourcing will inevitably be an issue, but the PROMIS and PRECISION papers provide a compelling health economic argument for funders. Less men undergoing biopsy; less biopsy cores; less complications; less insignificant cancer – this surely makes economic sense. In Australia, where MRI has already been enthusiastically embraced, a high-quality mpMRI on a 3T machine costs $USD300, and costs are usually borne by patients. In the USA, we hear that a 1.5T MRI (with an endorectal coil) can cost USD$2-3000!! Why is this?! Australia is an expensive country – an iPhone or a da Vinci robot costs 1.5 times the cost in the USA; why therefore should an MRI cost so much in the USA? A symptom of a much broader issue with the bloated US health economy, and likely a barrier to adoption of the paradigm proposed by PRECISION.

So there you have it. A truly practice-changing study. While there will be much discussion about the nuances, I for one will immediately embrace this paradigm:

  • MRI for all (I already do this)
  • Targeted biopsy alone for those with MRI lesions (a new departure for me)
  • No biopsy for those with normal MRI scans (unless there are other red flags).

My concluding slide from the plenary discussion:

 

Congrats again Veeru, Caroline, Mark and colleagues for publishing this landmark study.

 

Declan G Murphy

Urologist & Director of Genitourinary Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia

Twitter: @declangmurphy

 

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