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Video: TRUS-Guided RB Prostate Cancer Detection – Reasons for Targeted Biopsy Failure

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Prostate cancer detection on transrectal ultrasonography-guided random biopsy despite negative real-time magnetic resonance imaging/ultrasonography fusion-guided targeted biopsy: reasons for targeted biopsy failure

Hannes Cash*, Karsten Gunzel*, Andreas Maxeiner*, Carsten Stephan*, Thomas Fischer†, Tahir Durmus†, Kurt Miller*, Patrick Asbach†, Matthias Haas† and Carsten Kempkensteffen*

 

*Department of Urology, and †Department of Radiology, Charite–University of Medicine Berlin, Berlin, Germany M. H. and C.K. contributed equally to the study.

 

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Objective

To examine the value of additional transrectal ultrasonography (TRUS)-guided random biopsy (RB) in patients with negative magnetic resonance imaging (MRI)/ultrasonography (US) fusion-guided targeted biopsy (TB) and to identify possible reasons for TB failure.

Patients and Methods

We conducted a subgroup analysis of 61 men with prostate cancer (PCa) detected by 10-core RB but with a negative TB, from a cohort of 408 men with suspicious multiparametric magnetic resonance imaging (mpMRI) between January 2012 and January 2015. A consensus re-reading of mpMRI results (using Prostate Imaging Reporting and Data System [PI-RADS] versions 1 and 2) for each suspicious lesion was performed, with the image reader blinded to the biopsy results, followed by an unblinded anatomical correlation of the lesion on mpMRI to the biopsy result. The potential reasons for TB failure were estimated for each lesion. We defined clinically significant PCa according to the Epstein criteria and stratified patients into risk groups according to the European Association of Urology guidelines.

JulAOTW3Results

Results

Our analysis showed that RB detected significant PCa in 64% of patients (39/61) and intermediate-/high-risk PCa in 57% of patients (35/61). The initial mpMRI reading identified 90 suspicious lesions in the cohort. Blinded consensus re-reading of the mpMRI led to PI-RADS score downgrading of 45 lesions (50%) and upgrading of 13 lesions (14%); thus, negative TB could be explained by falsely high initial PI-RADS scores for 32 lesions (34%) and sampling of the target lesion by RB in the corresponding anatomical site for 36 out of 90 lesions (40%) in 35 of 61 patients (57%). Sampling of the target lesion by RB was most likely for lesions with PI-RADS scores of 4/5 and Gleason scores (GS) of ≥7. A total of 70 PCa lesions (67% with GS 6) in 44 patients (72%) were sampled from prostatic sites with no abnormalities on mpMRI.

Conclusion

In cases of TB failure, RB still detected a high rate of significant PCa. The main reason for a negative TB was a TB error, compensated for by positive sampling of the target lesion by the additional RB, and the second reason for TB failure was a falsely high initial PI-RADS score. The challenges that arise for both MRI diagnostics and prostate lesion sampling are evident in our data and support the integration of RB into the TB workflow.

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Highlights from BAUS 2016

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In the week following Britain’s exit from Europe after the BREXIT referendum, BAUS 2016 got underway in Liverpool’s BT convention Centre. This was the 72nd meeting of the British Association of Urological Surgeons and it was well attended with 1120 delegates (50% Consultant Member Urologists, 30% Trainees, 10% Non member Urologists/Other, 10% Nurses, HCP’S, Scientists).

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Monday saw a cautionary session on medicolegal aspects in Andrology, focusing on lawsuits over the last year. Mr Mark Speakman presented on the management issue of testicular torsion. This sparked further discussion on emergency cover for paediatrics with particular uncertainty noted at 4 and 5 year olds and great variation in approach dependent on local trust policy. Mr Julian Shah noted the most litigious areas of andrology, with focus on cosmesis following circumcisions. Therefore serving a reminder on the importance of good consent to manage patients’ expectations.

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In the Dragons’ Den, like the TV show, junior urologists pitched their ideas for collaborative research projects, to an expert panel. This year’s panel was made up of – Mark Emberton, Ian Pearce, and Graeme MacLennan. The session was chaired by Veeru Kasivisvanathan, Chair of the BURST Research Collaborative.

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Eventual winner Ben Lamb, a trainee from London, presented “Just add water”. The pitch was for an RCT to investigate the efficacy of water irrigation following TURBT against MMC in reducing tumour recurrence. Ben proposed that water, with its experimental tumouricidal properties, might provide a low risk, low cost alternative as an adjuvant agent following TURBT. Judges liked the scientific basis for this study and the initial planning for an RCT. The panel discussed the merits of non-inferiority vs. superiority methodology, and whether the team might compare MMC to MMC with the addition of water, or water instead of MMC. They Dragons’ suggested that an initial focus group to investigate patients’ views on chemotherapy might help to focus the investigation and give credence to the final research question, important when making the next pitch- to a funding body, or ethics committee.

Other proposals were from Ryad Chebbout, working with Marcus Cumberbatch, an academic trainee from Sheffield. Proposing to address the current controversy over the optimal surgical technique for orchidopexy following testicular torsion. His idea involved conducting a systematic review, a national survey of current practice followed by a Delphi consensus meeting to produce evidence based statement of best practice. The final presentation was from Sophia Cashman, East of England Trainee for an RCT to assess the optimal timing for a TWOC after urinary retention. The panel liked the idea of finally nailing down an answer to this age-old question.

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Waking up on Tuesday with England out of the European football cup as well as Europe the conference got underway with an update from the PROMIS trial (use of MRI to detect prostate cancer). Early data shows that multi-parametric MRI may be accurate enough to help avoid some prostate biopsies.

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The SURG meeting provided useful information for trainees, with advice on progressing through training and Consultant interviews. A debate was held over run through training, which may well be returning in the future. The Silver cystoscope was awarded to Professor Rob Pickard voted for by the trainees in his deanery, for his devotion to their training.
Wednesday continued the debate on medical expulsion therapy (MET) for ureteric stones following the SUSPEND trial. Most UK Urologists seem to follow the results of the trial and have stopped prescribing alpha blockers to try and aid stone passage and symptoms. However the AUA are yet to adopt this stance and feel that a sub analysis shows some benefit for stones >5mm, although this is not significant and pragmatic outcomes. Assistant Professor John Hollingsworth (USA) argued for MET, with Professor Sam McClinton (UK) against. A live poll at the end of the session showed 62.9% of the audience persuaded to follow the SUSPEND trial evidence and stop prescribing MET.

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In the debate of digital versus fibreoptic scopes for flexible ureteroscopy digital triumphed, but with a narrow margin.

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In other updates and breaking news it appears that BCG is back! However during the shortage EMDA has shown itself to be a promising alternative in the treatment of high grade superficial bladder cancer.
The latest BAUS nephrectomy data shows that 90% are performed by consultant, with 16 on average per consultant per year. This raises some issues for registrar training, however with BAUS guidelines likely to suggest 20 as indicative numbers this is looking to be an achievable target for most consultants. Robotic advocates will be encouraged, as robotic partial nephrectomy numbers have overtaken open this year. The data shows 36% of kidney tumours in the under 40 years old are benign. Will we have to consider biopsying more often? However data suggests we should be offering more cytoreductive nephrectomies, with only roughly 1/10 in the UK performed compared to 3/10 in the USA.

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The andrology section called for more recruitment to The MASTER trial (Male slings vs artificial urinary sphincters), whereas the OPEN trial has recruited(open urethroplasty vs optical urethotomy). In the treatment of Peyronie’s disease collagenase has been approved by NICE but not yet within the NHS.

Endoluminal endourology presentation showed big increases in operative numbers with ureteroscopy up by 50% and flexible ureteroscopy up by 100%. Stents on strings were advocated to avoid troubling stent symptoms experienced by most patients. New evidence may help provide a consensus on defining “stone free” post operation. Any residual stones post-operatively less than 2mm were shown to pass spontaneously and therefore perhaps may be classed as “stone free”.

Big changes seem likely in the treatment of benign prostatic hyperplasia, with a race to replace the old favorite TURP. Trials have of TURP (mono and bipolar) vs greenlight laser are already showing similar 2 year outcomes with the added benefit of shorter hospital stays and less blood loss. UROLIFT is an ever more popular alternative with data showing superiority to TURP in lifestyle measures, likely because it preserves sexual function, and we are told it can be performed as a 15 minute day case operation. The latest new therapy is apparently “Aquabeam Aquablation”, using high pressured water to remove the prostate. Non surgical treatments are also advancing with ever more accurate super selective embolisation of the prostatic blood supply.

1.11

This year all accepted abstracts were presented in moderated EPoster sessions. The format was extremely successful removing the need for paper at future conferences? A total of 538 abstracts were submitted and 168 EPosters displayed. The winner of best EPoster was P5-5 Altaf Mangera: Bladder Cancer in the Neuropathic Bladder.

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The best Academic Paper winner was Mark Salji of the CRUK Beatson institute, titled “A Urinary Peptide Biomarker Panel to Identify Significant Prostate Cancer”. Using capillary electrophoresis coupled to mass spectrometry (CE-MS) they analysed 313 urine samples from significant prostate cancer patients (Gleason 8-10 or T3/4 disease) and low grade control disease. They identified 94 peptide urine biomarkers which may provide a useful adjunct in identifying significant prostate cancer from insignificant disease.

The Office of Education offered 20 courses. Popular off-site courses were ultrasound for the Urologist, at Broadgreen Hospital, a slightly painful 30 min drive from the conference centre. However well worth the trip, delivered by Radiology consultants this included the chance to scan patients volunteers under guidance, with separate stations for kidneys, bladder and testicles and learning the “knobology” of the machines.

Organised by Tamsin Greenwell with other consultant experts in female, andrology and retroperitoneal cancer, a human cadaveric anatomy course was held at Liverpool university. The anatomy teaching was delivered by both Urology consultants and anatomists allowing for an excellent combination of theory and functional anatomy.

BAUS social events are renowned and with multiple events planned most evenings were pretty lively. The official drinks reception was held at the beautiful Royal Liver Building. The venue was stunning with great views over the waterfront and the sun finally shining. Several awards were presented including the Gold cystoscope to Mr John McGrath for significant contribution to Urology within 10 years appointment as consultant. The Keith Yeates medal was awarded to Mr Raj Pal, the most outstanding candidate in the first sitting of the intercollegiate specilaity examination, with a score of over 80%.

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During the conference other BAUS awards presented include the St Peter’s medal was awarded to Margeret Knowles, Head of section of molecular oncology, Leeds Institute of Cancer and Pathology, St James University hospital Leeds. The St Paul’s medal awarded to Professor Joseph A. Smith, Vanderbilt University, Nashville, USA. The Gold medal went to Mr. Tim Terry, Leicester General Hospital.

An excellent industry exhibition was on display, with 75 Exhibiting Companies present. My personal fun highlight was a flexible cystoscope with integrated stent remover, which sparked Top Gear style competiveness when the manufacturer set up a time-trial leaderboard. Obviously this best demonstrated the speed of stent removal with some interesting results…

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Social media review shows good contribution daily.

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Thanks BAUS a great conference, very well organised and delivered with a great educational and social content, looking forward to Glasgow 2017! #BAUS2017 #Glasgow #BAUSurology

Nishant Bedi

Specialist Training Registrar North West London 

Twitter: @nishbedi

 

Article of the Week: Patterns of prescription and adherence to EAU guidelines on ADT in PCa

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Giuseppe Morgia and Giorgio Ivan Russo, discussing their paper.

If you only have time to read one article this week, it should be this one.

Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study

Giuseppe Morgia1, Giorgio Ivan Russo1, Andrea Tubaro2, Roberto Bortolus3, Donato Randone4, Pietro Gabriele5, Fabio Trippa6, Filiberto Zattoni7, Massimo Porena8, Vincenzo Mirone9, Sergio Serni10, Alberto Del Nero11, Giancarlo Lay12 , Umberto Ricardi13, Francesco Rocco14, Carlo Terrone15, Arcangelo Pagliarulo16, Giuseppe Ludovico17, Giuseppe Vespasiani18, Maurizio Brausi19, Claudio Simeone20, Giovanni Novella21, Giorgio Carmignani22, Rosario Leonardi23, Paola Pinnaro5, Ugo De Paula24, Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana d’Urologia)

 

1 Department of Urology, University of Catania, Catania, 2 Department of Urology, Sant’ Andrea Hospital, ‘La Sapienza’ University of Roma, Roma, 3 S.O. Oncologia Radioterapica, Pordenone, 4 Urology, Presidio Ospedaliero Gradenigo, Torino, 5 Radiotherapy, IRCC Candiolo, Torino, 6 Radiotherapy, A.O. Santa Maria, Terni, 7 Department of Urology, University of Padova, Padova, 8 Department of Urology, University of Perugia, Perugia, 9 Department of Urology, Universita Federico II of Napoli, Napoli,
10 Department of Urology, University of Firenze, Firenze, 11 Urologia I, Azienda Ospedaliera San Paolo, Milano, 12 Radiotherapy, ASL of Cagliari, Cagliari, 13 Radiotherapy, AOU University S. Giovanni Battista Molinette, Torino, 14 Department of Urology, University of Milano, Milano, 15Urology, University Hospital ‘Maggioredella Carita’, Novara,16 Urology, University of Bari, Bari, 17 Urology, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, 18 Department of Urology, University Tor Vergata, Roma, 19 Urology, Ospedale Civile Ramazzini, Carpi, 20 Department of Urology, University of Brescia, Brescia, 21 Department of Surgery, Urology Clinic, AOUI Verona, Verona, 22 Department of Urology, University of Genova, Genova, 23 Urology, Centro Uro-Andrologico La CURA, Acireale, 24 Radiotherapy, AO S. Giovanni Addolorata, Roma, 25 Radiotherapy, Istituto Nazionale per la Ricerca, Genova, 26 Department of Urology, University of Chieti, Chieti, 27 Department of Urology, University of Trieste, Trieste, 28 Radiotherapy, Policlinico Universitario Agostino Gemelli, Roma, 29 Department of Surgical Sciences, Città della Salutee della Scienza, University of Torino, Torino, 30 Urology, Fondazione Istituto San Raffaele – G. Giglio di Cefalù, Cefalù, and 31 Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy

 

Read the full article

Objective

To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription.

Methods

The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B).

AOTWJun5Results

Results

The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D’Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT.

Conclusion

EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Read more articles of the week

Editorial: EAU guidelines – do we care? Reflections from the EAU Impact Assessment of Guidelines Implementation and Education group

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There is increasing evidence in the literature that androgen deprivation therapy (ADT) is overused among practising urologists in the setting of localized, and even locally advanced, prostate cancer (PCa) [1, 2]. Morgia et al. [1] report a misuse of ADT prescriptions among Italian urologists in roughly a quarter of cases, mainly in the setting of low-risk/localized disease where ADT may harm patients without proven benefit with regard to disease-specific outcomes [3]. Such clinical practice behaviours are even more unjustifiable given the high level of evidence upon which the current European Association of Urology (EAU) guidelines recommendations on ADT use are based [4].

Morgia et al. [1] should be congratulated for highlighting the magnitude of the problems the urological community currently face in terms of the gap between evidence and practice. Unfortunately, while the authors report significant geographical differences in ADT prescriptions within the same country (Italy), the methods they used in their study do not allow an understanding of the reasons for the discrepancy. It is currently unknown whether the gap between evidence and practice is attributable to physician or patient attitude or to the national health system structure. The inclusion of qualitative methods, such as semi-structured interviews, would have been ideal to probe clinician reasoning for discordant adherence. This is crucial because knowledge of possible barriers to the application of guidelines represents a key step in their implementation process. Indeed, once the issue is raised, the next logical questions to pose would be: how can we reduce such variation in urological practice especially where there is a real risk of causing harm to patients and how can we improve and implement the use of guideline recommendations when clearly underpinned by high-quality evidence?

It is indeed intuitive that any huge evidence–practice gap may have profound implications not only in the process of patient care optimization but also in the context of national healthcare efficiency.

Certainly the issue of ADT overuse raised by Morgia et al. [1] can be considered the perfect setting to scale up and prioritize efforts aimed at improving current urological practice for three main reasons: (i) the high prevalence of the disease studied (namely, PCa); (ii) the availability of an up-to-date evidence-based guideline showing the impact of ADT in terms of patient side effects and costs; and (iii) the now known gap between evidence and practice patterns.

Given this setting, it should then be mandatory to promote ways not only to assess the use of guideline recommendations but also to increase dissemination among users (not only healthcare professionals, but also patients and policy makers) and to evaluate their impact. The aim of this highly articulated process of knowledge translation is eventually to move research findings into clinical practice. Ideally, this approach should be based on the following five crucial questions: (i) What should be transferred? (ii) To whom should research knowledge be transferred? (iii) By whom should research knowledge be transferred? (iv) How should research knowledge be transferred? and (v) To what effect should research knowledge be transferred? [5]. Each of these questions represents a crucial step in any knowledge translation process. To optimize this approach, it is critical to identify barriers to knowledge implementation and to choose the optimum interventions to limit or to overcome them. This ‘global process’ is much more complicated than commonly thought, given the significant cultural, social, economic and health system differences not only between countries but also within the same country, as shown by Morgia et al. [1]. It is likely, therefore, that any knowledge implementation approach should be tailored according to each country and should be based on key steps, such as: selection of a credible ‘messenger’; development of the appropriate technological and organizational instruments to facilitate access to disseminate and use existing high-quality evidence; and the setting up of education programmes to improve clinical research literacy skills.

Finally, we believe that the paper by Morgia et al. [1] strongly supports the notion that ‘evidence-based medicine should be complemented by evidence-based implementation’ [6]. It is indeed likely that creating a knowledge translation setting where the gap between evidence and practice is eventually bridged is as important as producing accurate, scientifically sound and meticulous guidelines that can be trusted by all stakeholders.

Tackling the crucially important problem of discordant guideline adherence is the remit of the recently established EAU Guidelines Office ‘IMAGINE’ project (IMpact Assessment of Guidelines Implementation and Education) which aims to: ascertain adherence to prioritized guideline recommendations; elucidate the barriers and facilitators to change; design bespoke knowledge transfer interventions; and evaluate the impact of the EAU guidelines, thereby optimizing adherence, with the ultimate goal of improving patient care.

Read the full article
Alberto Briganti*, Steven MacLennan†, Lorenzo Marconi‡, Karin Plass§ and James N’Dow †on behalf of EAU Guidelines Office ‘IMAGINE’ project
*Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy, †Academic Urology Unit, University of Aberdeen, Aberdeen, UK, ‡Department of Urology, Coimbra University Hospital, Coimbra, Portugal and §EAU Central Office, Guidelines Office, Arnhem, The Netherlands

 

References

 

1 Morgia G, Russo GI, Tubaro A et al. Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross- sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study. BJU Int 2016; 117: 867–73

 

2 Lycken M, Garmo H, Adolfsson J, Stattin P, Holmberg L, Bill-Axelson A. Patterns of androgen deprivation therapies among men diagnosed with localised prostate cancer: a population-based study. Eur J Cancer 2014; 50: 1789–98

 

3 Lu-Yao GL, Albertsen PC, Moore DF et al. Survival following primary androgen deprivation therapy among men with localized prostate cancer. JAMA 2008; 300: 173–81

 

4 Heidenreich A, Bastian PJ, Bellmunt J et al. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2014; 65: 467–79

 

5 Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Suires JE. Knowledge translation of research findings. Implement Sci 2012; 7: 50

 

6 Grol R. Beliefs and evidence in changing clinical practice. BMJ 1997; 315: 418–21

 

Video: Patterns of prescription and adherence to EAU guidelines on ADT in PCa

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Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study

Giuseppe Morgia1, Giorgio Ivan Russo1, Andrea Tubaro2, Roberto Bortolus3, Donato Randone4, Pietro Gabriele5, Fabio Trippa6, Filiberto Zattoni7, Massimo Porena8, Vincenzo Mirone9, Sergio Serni10, Alberto Del Nero11, Giancarlo Lay12 , Umberto Ricardi13, Francesco Rocco14, Carlo Terrone15, Arcangelo Pagliarulo16, Giuseppe Ludovico17, Giuseppe Vespasiani18, Maurizio Brausi19, Claudio Simeone20, Giovanni Novella21, Giorgio Carmignani22, Rosario Leonardi23, Paola Pinnaro5, Ugo De Paula24, Renzo Corvo25, Raffaele Tenaglia26, Salvatore Siracusano27, Giovanna Mantini28, Paolo Gontero29, Gianfranco Savoca30 and Vincenzo Ficarra31 (Members of the LUNA Foundation, Societa Italiana d’Urologia)

 

1 Department of Urology, University of Catania, Catania, 2 Department of Urology, Sant’ Andrea Hospital, ‘La Sapienza’ University of Roma, Roma, 3 S.O. Oncologia Radioterapica, Pordenone, 4 Urology, Presidio Ospedaliero Gradenigo, Torino, 5 Radiotherapy, IRCC Candiolo, Torino, 6 Radiotherapy, A.O. Santa Maria, Terni, 7 Department of Urology, University of Padova, Padova, 8 Department of Urology, University of Perugia, Perugia, 9 Department of Urology, Universita Federico II of Napoli, Napoli,
10 Department of Urology, University of Firenze, Firenze, 11 Urologia I, Azienda Ospedaliera San Paolo, Milano, 12 Radiotherapy, ASL of Cagliari, Cagliari, 13 Radiotherapy, AOU University S. Giovanni Battista Molinette, Torino, 14 Department of Urology, University of Milano, Milano, 15Urology, University Hospital ‘Maggioredella Carita’, Novara,16 Urology, University of Bari, Bari, 17 Urology, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, 18 Department of Urology, University Tor Vergata, Roma, 19 Urology, Ospedale Civile Ramazzini, Carpi, 20 Department of Urology, University of Brescia, Brescia, 21 Department of Surgery, Urology Clinic, AOUI Verona, Verona, 22 Department of Urology, University of Genova, Genova, 23 Urology, Centro Uro-Andrologico La CURA, Acireale, 24 Radiotherapy, AO S. Giovanni Addolorata, Roma, 25 Radiotherapy, Istituto Nazionale per la Ricerca, Genova, 26 Department of Urology, University of Chieti, Chieti, 27 Department of Urology, University of Trieste, Trieste, 28 Radiotherapy, Policlinico Universitario Agostino Gemelli, Roma, 29 Department of Surgical Sciences, Città della Salutee della Scienza, University of Torino, Torino, 30 Urology, Fondazione Istituto San Raffaele – G. Giglio di Cefalù, Cefalù, and 31 Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy

 

Read the full article

Objective

To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription.

Methods

The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B).

AOTWJun5Results

Results

The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D’Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT.

Conclusion

EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Read more articles of the week

Article of the Month: Gleason Grading in the Spotlight

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Every Month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Klaus Brasso, discussing his paper.

If you only have time to read one article this week, it should be this one.

The impact of the 2005 International Society of Urological Pathology consensus guidelines on Gleason grading – a matched pair analysis

Kasper D. Berg*, Frederik B. Thomsen*, Camilla Nerstrøm*, Martin A. Røder*, Peter
Iversen*, Birgitte G. Toft†, Ben Vainer† and Klaus Brasso*

 

*Department of Urology, Copenhagen Prostate Cancer Center and †Department of Pathology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

 

Read the full article

Objectives

To investigate whether the International Society of Urological Pathology (ISUP) 2005 revision of the Gleason grading system has influenced the risk of biochemical recurrence (BCR) after radical prostatectomy (RP), as the new guideline implies that some prostate cancers previously graded as Gleason score 6 (3 + 3) are now considered as 7 (3 + 4).

Patients and methods

A matched-pair analysis was conducted. In all, 215 patients with Gleason score 6 or 7 (3 + 4) prostate cancer on biopsy who underwent RP before 31 December 2005 (pre-ISUP group), were matched 1:1 by biopsy Gleason score, clinical tumour category, PSA level, and margin status to patients undergoing RP between 1 January 2008 and 31 December 2011 (post-ISUP group). Patients were followed until BCR defined as a PSA level of ≥0.2 ng/mL. Risk of BCR was analysed in a competing-risk model.

JunAOTMResults

Results

The median follow-up was 9.5 years in the pre-ISUP group and 4.8 years in the post-ISUP group. The 5-year cumulative incidences of BCR were 34.0% and 13.9% in the pre-ISUP and post-ISUP groups, respectively (P < 0.001). The difference in cumulative incidence applied to both patients with Gleason score 6 (P < 0.001) and 7 (3 + 4) (P = 0.004). There was no difference in the 5-year cumulative incidence of BCR between patients with pre-ISUP Gleason score 6 and post-ISUP Gleason score 7 (3 + 4) (P = 0.34). In a multiple Cox-proportional hazard regression model, ISUP 2005 grading was a strong prognostic factor for BCR within 5 years of RP (hazard ratio 0.34; 95% confidence interval 0.22–0.54; P < 0.001).

Conclusion

The revision of the Gleason grading system has reduced the risk of BCR after RP in patients with biopsy Gleason score 6 and 7 (3 + 4). This may have consequences when comparing outcomes across studies and historical periods and may affect future treatment recommendations.

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Editorial: Current Gleason score 3 + 4 = 7: has it lost its significance compared with its historical counterpart?

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Berg et al. [1] report that patients classified as Gleason score 7 (3 + 4) according to the revised grading system published in 2005 are to some extent similar to patients with pre-2005 Gleason score 6, at least in terms of risk of biochemical recurrence. The logical but not necessarily correct conclusion is that current patients with Gleason score 7 on biopsy are appropriate candidates for active surveillance.

What must be kept in mind is that, using the post-2005 revised grading system, approximately 25% of men with Gleason score 3 + 4 = 7 on biopsy have either 3 + 4 = 7 with tertiary pattern 5 or >4 + 3 = 7 in the corresponding radical prostatectomy [1]. With the exception of men with a limited life expectancy, these men need definitive therapy for their potentially life-threatening cancer. Numerous studies have shown that extended biopsies, whether they are >10- or 12-core, are associated with less upgrading than sextant biopsies [2]. In the report by Berg et al. [1], the median number of cores sampled before 2005 was 6 with an interquartile range (IQR) of 6–6 compared with a median (IQR) of 10 (10–12) cores after 2005. Consequently, in their cohorts, the pre-2005 group of men with Gleason score 3 + 3 = 6 were more likely to have unsampled higher grade cancer and a correspondingly worse prognosis more closely approximating post-2005 better-sampled Gleason score 3 + 4 = 7 cancers.

Berg et al. [1] further claim that the prognostic and clinical value of Gleason score 7 has been weakened since the 2005 modifications. In fact, the revised grading system more accurately reflects prostate cancer biology than the pre-2005 Gleason system. The major consequence of the modification, as Berg et al. [3] illustrate, has been the better prognosis associated with post-2005 Gleason score 6 cancer because patterns associated with more aggressive behaviour have been shifted to Gleason score 7. Historically, a diagnosis of Gleason score 6 cancer, even at radical prostatectomy, was not as predictive of ‘good’ behaviour, and had a higher rate of progression with some men even dying from prostate cancer [4]. Currently, Gleason score 6 cancer at radical prostatectomy has a 96% cure rate at 5 years, even including cases with extraprostatic extension and positive margins [3]. Several studies have shown that post-2005 pure Gleason score 6 cancers at radical prostatectomy are incapable of metastasizing to lymph nodes [4]. Berg et al. are correct, however, that men with a post-2005 grade of Gleason Score 3 + 4 = 7 have a better prognosis than those graded prior to 2005. As a consequence, it has been recommended that pathologists should record the percent pattern 4 in cases with Gleason score 7 on biopsy for men being considered for active surveillance [5]. For the appropriate patient, depending on age, comorbidity, extent of cancer, MRI findings, patient desire, etc., could be a candidate for active surveillance with Gleason score 3 + 4 = 7 if the pattern 4 is limited. Currently, this information is not transparent in most pathology reports.

A new grading system, first proposed in BJUI by this author, and verified in a large multi-institutional study, resulted in a simplified five-grade group system that more accurately reflects the biology of prostate cancer than the pre-2005 grading system [3, 6]. Men with Gleason score 6 cancers need to be reassured that their cancer is the lowest grade that is currently assigned, despite Gleason scores ranging from 2 to 10. In addition, I have talked to some patients with Gleason score 3 + 4 = 7 who think that they are going to die in the near future because their score of 7 was closer to highest grade of 10 than the lowest grade of 2. With the new grading system, patients can be reassured that they have a Grade group 1 (3 + 3 = 6) out of 5, which is the lowest grade, or a Grade group 2 (Gleason score 3 + 4 = 7) out of 5, which is still a relatively low grade.

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Jonathan I. Epstein
Departments of Pathology, Urology and Oncology, The Johns Hopkins Medical Institutions, Baltimore, MD, USA

 

References

 

1 Berg KD, Thomsen FB, Nerstrom C et al. The impact of the 2005 International Society of Urological Pathology consensus guidelines on Gleason grading – a matched pair analysis. BJU Int 2016; 117: 883–9

 

2 Epstein JI, Feng Z, Trock BJ , Pierorazio PM. Upgrading and downgrading of prostate cancer from biopsy to radical prostatectomy: incidence and predictive factors using the modified Gleason grading system and factoring in tertiary grades. Eur Urol 2012; 61: 1019–24

 

3 Epstein JI, Zelefsky MJ, Sjoberg DD et al. A contemporary prostate cancer grading system: a validated alternative to Gleason score. Eur Urol 2016; 69: 428–35

 

4 RossHM, Kryvenko ON, Cowan JE, Simko JP, Wheeler TM, Epstein JI. Do adenocarcinomas of the prostate with Gleason score (GS) ≤ 6have the potential to metastasize to lymph nodes? Am J Surg Pathol 2012; 36: 1346–52

 

5 Kryvenko ON, Epstein JI. Prostate cancer grading: a decade after the 2005 modified Gleason grading system. Arch Pathol Lab Med 2016; [Epub ahead of print]

 

6 Pierorazio PM, Walsh PW, Partin AW, Epstein JI. Prognostic Gleason grade grouping: data based on the modified Gleason scoring system. BJU Int 2013; 111: 753–60

 

Video: Gleason Grading in the Spotlight

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The impact of the 2005 International Society of Urological Pathology consensus guidelines on Gleason grading – a matched pair analysis

Kasper D. Berg*, Frederik B. Thomsen*, Camilla Nerstrøm*, Martin A. Røder*, Peter Iversen*, Birgitte G. Toft†, Ben Vainer† and Klaus Brasso*

 

*Department of Urology, Copenhagen Prostate Cancer Center and †Department of Pathology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

 

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Objectives

To investigate whether the International Society of Urological Pathology (ISUP) 2005 revision of the Gleason grading system has influenced the risk of biochemical recurrence (BCR) after radical prostatectomy (RP), as the new guideline implies that some prostate cancers previously graded as Gleason score 6 (3 + 3) are now considered as 7 (3 + 4).

Patients and methods

A matched-pair analysis was conducted. In all, 215 patients with Gleason score 6 or 7 (3 + 4) prostate cancer on biopsy who underwent RP before 31 December 2005 (pre-ISUP group), were matched 1:1 by biopsy Gleason score, clinical tumour category, PSA level, and margin status to patients undergoing RP between 1 January 2008 and 31 December 2011 (post-ISUP group). Patients were followed until BCR defined as a PSA level of ≥0.2 ng/mL. Risk of BCR was analysed in a competing-risk model.

JunAOTMResults

Results

The median follow-up was 9.5 years in the pre-ISUP group and 4.8 years in the post-ISUP group. The 5-year cumulative incidences of BCR were 34.0% and 13.9% in the pre-ISUP and post-ISUP groups, respectively (P < 0.001). The difference in cumulative incidence applied to both patients with Gleason score 6 (P < 0.001) and 7 (3 + 4) (P = 0.004). There was no difference in the 5-year cumulative incidence of BCR between patients with pre-ISUP Gleason score 6 and post-ISUP Gleason score 7 (3 + 4) (P = 0.34). In a multiple Cox-proportional hazard regression model, ISUP 2005 grading was a strong prognostic factor for BCR within 5 years of RP (hazard ratio 0.34; 95% confidence interval 0.22–0.54; P < 0.001).

Conclusion

The revision of the Gleason grading system has reduced the risk of BCR after RP in patients with biopsy Gleason score 6 and 7 (3 + 4). This may have consequences when comparing outcomes across studies and historical periods and may affect future treatment recommendations.

Read more articles of the week

Article of the Week: 68Ga-PSMA has high detection rate of PCa recurrence after RP

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

68Ga-PSMA has high detection rate of prostate cancer recurrence outside the prostatic fossa in patients being considered for salvage radiation treatment

 

Pim J. van Leeuwen*†, Phillip Stricker*†, George Hruby‡§, Andrew Kneebone‡§, Francis Ting*†, Ben Thompson†, Quoc Nguyen†, Bao Ho** and Louise Emmett**,††

 

*St Vincent’s Prostate Cancer Centre, St Vincent’s Clinic, Sydney, NSW, †Australian Prostate Cancer Research Centre – New South Wales, Garvan Institute of Medical Research/Kinghorn Cancer Centre, Sydney, NSW, ‡Radiation Oncology Department, Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards, NSW, §University of Sydney, Sydney, NSW, Northern Clinical School, University of Sydney, St Leonards, NSW, **Department of Diagnostic Imaging, St Vincent’s Public Hospital, Sydney, NSW, and ††University of New South Wales, Sydney, NSW, Australia

 

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Objectives

To examine the detection rates of 68Ga-PSMA-positron emission tomography (PET)/computed tomography (CT) in patients with biochemical recurrence (BCR) after radical prostatectomy (RP), and also the impact on their management.

Materials and Methods

A total of 300 consecutive patients with prostate cancer (PCa) who underwent 68Ga-PSMA-PET/CT between February and July 2015 were prospectively included in the Prostate Cancer Imaging (ProCan-I) database. For the present analysis, we included patients with BCR (prostate-specific antigen [PSA] level ≥0.05 and <1.0 ng/mL) after RP, who were being considered for salvage radiation therapy (RT) according to the Faculty of Radiation Oncology Genito-Urinary Group (FROGG) guidelines. Two readers assessed each 68Ga-PSMA-PET/CT, and all positive lesions were assigned to an anatomical location. For each patient, the clinical and pathological features were recorded, their association with pathological 68Ga-PSMA uptake was investigated, and detection rates were determined according to PSA level.

AOTWMAY

Results

A total of 70 patients were included, and 53 positive 68Ga-PSMA lesions were detected in 38 (54%) patients. Among patients with PSA levels 0.05–0.09 ng/mL, 8% were definitely positive; the corresponding percentages for the other PSA ranges were as follows: PSA 0.1–0.19 ng/mL, 23%; PSA 0.2–0.29 ng/mL, 58%; PSA 0.3–0.49 ng/mL, 36%; and PSA 0.5–0.99 ng/mL, 57%. Eighteen of 70 patients (27%) had pathological 68Ga-PSMA uptake in the prostatic fossa, 11 (14.3%) in the pelvic nodes, and five (4.3%) in both the fossa and pelvic lymph nodes. Finally, there was uptake outside the pelvis with or without a lesion in the fossa or pelvic lymph nodes in four cases (8.6%). As a result of the 68Ga-PSMA findings there was a major management change in 20 (28.6%) patients.

Conclusions

68Ga-PSMA appears to be useful for re-staging of PCa in patients with rising PSA levels who are being considered for salvage RT even at PSA levels <0.5 ng/mL. These results underline the need for further prospective trials to evaluate the changes in RT volume or management attributable to 68Ga-PSMA findings.

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Editorial: PSMA-targeted imaging of PCa – the best is yet to come

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In recent years there has been increasing interest in imaging recurrent or metastatic prostate cancer with positron-emission tomography (PET) radiotracers targeting prostate-specific membrane antigen (PSMA [1]). The majority of this work has been performed using urea-based small molecules labelled with gallium-68 (68Ga). Within this class of radiotracers, 68Ga-PSMA-11 (also known as 68Ga-PSMA-HBED-CC) has been the most widely studied. In this month’s edition of BJUI, van Leeuwen et al. [2] report on the clinical utility of 68Ga-PSMA-11 PET/CT in men with rising PSA levels after radical prostatectomy being considered for salvage radiation therapy. In their study, 70 patients with negative conventional imaging findings and a median PSA of 0.2 ng/mL (all <1 ng/mL) were imaged with 68Ga-PSMA-11 PET/CT prior to initiating treatment. On PSMA-targeted PET/CT, 53 lesions were detected in 38 (54%) patients. Perhaps most significant among their findings was that 28.6% of men had radiotracer uptake outside of the prostatic fossa leading to a major change in clinical management. In total, these data demonstrate the great potential of PSMA-targeted imaging, particularly in men with biochemically recurrent prostate cancer.

While a great deal of encouraging data with 68Ga-PSMA-11 has appeared in the medical literature, it is worth noting that several other small molecules that offer potential advantages over this agent have seen early clinical development. For example, PSMA-617 makes use of the DOTA chelation moiety in place of HBED-CC, allowing for a scaffold that can accommodate both diagnostic 68Ga and therapeutic lutetium-177 (177Lu) [3]. Additionally, our group has focused on fluorine-18 (18F)-labelled urea-based small molecules targeting PSMA, most recently 18F-DCFPyL [4]. 18F-labelled small molecules offer several potential advantages over those labelled with 68Ga. These include more favourable dosimetry allowing for higher injected radiotracer doses and lower-energy emitted positrons that have shorter path lengths to annihilation and therefore higher intrinsic spatial resolution [5]. Notably, a recent direct comparison of 68Ga-PSMA-11 and 18F-DCFPyL performed by Dietlein et al. [6] seems to confirm these advantages, having observed a higher rate of lesion detection as well as superior mean tumour-to-background ratios with the radiofluorinated compound. An additional advantage of 18F-labelled compounds is related to their longer half-life for radionuclide decay (109 vs 68 min for 68Ga). Given this difference, agents incorporating 68Ga typically require an on-site generator for radiotracer production, whereas 18F-based radiotracers can be produced en masse at a central site with a cyclotron and then delivered to remote locations via pre-existing distribution infrastructure (e.g. PETNET in the USA). Table 1 summarizes several relevant differences in the physical properties of 68Ga and 18F.

Table 1. Comparison of gallium-68 and fluorine-18
Radionuclide 68Ga 18F
Half-life, min 68 109
Method of production Generator Cyclotron
Average positron energy, keV 836.0 249.3
Average path length in soft tissue, mm 8.1 2.4
Positron yield per 100 disintegrations 89.14 96.86

 

In summary, these are exceptionally exciting times for the study of PSMA-targeted imaging of prostate cancer. With continued radiotracer development and accompanying well-designed clinical trials, there is no doubt we can drastically improve the care of men with prostate cancer.

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Michael A. Gorin*, Martin G. Pomper† and Steven P. Rowe†

 

*The James Buchanan Brady Urological Institute and Department of Urology, and †Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA

 

References

 

1 Lutje S, Heskamp S, Cornelissen AS et al. PSMA ligands for radionuclide imaging and therapy of prostate cancer: clinical status. Theranostics 2015; 5: 1388–401

 

2 van Leeuwen PJ, Stricker P, Hruby G et al. 68Ga-PSMA has a high detection rate of prostate cancer recurrence outside the prostatic fossa in patients being considered for salvage radiation treatment. BJU Int 2016; 117: 732–9

 

3 Afshar-Oromieh A, Hetzheim H, Kratochwil C et al. The theranostic PSMA ligand PSMA-617 in the diagnosis of prostate cancer by PET/CT: biodistribution in humans, radiation dosimetry, and first evaluation of tumor lesions. J Nucl Med 2015; 56: 1697–705

 

4 Szabo Z, Mena E, Rowe SP et al. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Mol Imaging Biol 2015; 17: 565–74
5 Sanchez-Crespo A. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission tomography. Appl Radiat Isot 2013; 76: 55–62

 

6 Dietlein M, Kobe C, Kuhnert G et al. Comparison of [18F]DCFPyL and [68Ga]Ga-PSMA-HBED-CC for PSMA-PET imaging in patients with relapsed prostate cancer. Mol Imaging Biol 2015; 17: 575–84

 

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