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Editorial: Optimal Thromboprophylaxis Remains a Challenge

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The ‘Guideline of guidelines: thromboprophylaxis for urological surgery’, published in this month’s issue of BJUI by Violette et al. [1], addresses a critical issue in urological practice and offers a comprehensive overview of available guidelines. Many urological surgeries, especially cancer surgeries, present a significant risk of thromboembolism, as well as bleeding. Therefore, urological surgeons should be well educated in the matter in order to be able to offer optimal prophylaxis to patients. Reading through the current recommendations and guidelines, one realises the wide variety of possible ways to risk stratify a patient, but also the large differences in opinions on how and when to offer prophylaxis. Consequently, even members within the same national society treat their patients in completely different ways.

The ideal recommendation will have to be individualised, taking thromboembolic and bleeding risk into account for each individual patient and specific surgery type. This stratification of patients not only presents a challenge in clinical practice but also for the design of meaningful clinical trials. As many medical questions regarding thromboprophylaxis remain unanswered, the currently available recommendations are based on our pathophysiological understanding and remain eminence-based, rather than evidence-based.

For many years, the ‘Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines’ [2] were viewed as the most respected guidelines in surgery. They include recommendations for a wide variety of surgical procedures, including urological surgeries. With an ageing population, our patients will more often be on anticoagulant treatment before surgery. While most guidelines still recommend stopping the anticoagulant treatment and bridging with heparin, new evidence from randomised controlled trials [3, 4] indicate that bridging by heparin significantly increases the risk for major bleeding without reducing the thromboembolic risk in most patients. Despite a recent appeal by internists and cardiologists [5], revised guidelines from the American College of Chest Physicians to replace the partially outdated recommendations have yet to be published. As mentioned by Violette et al. [1] in their current review, bridging should probably only be offered to a limited number of patients with a very high risk of thromboembolic complications.

Whether the recommendations for acetylsalicylic acid prophylaxis will be changed similarly (to stopping perioperatively in all but high-risk patients) is less clear [6]. More clinical evidence is needed here.

The European Association of Urology has recognised the problem and presented the prospect of providing a guideline on thromboprophylaxis for urological procedures later this year. Looking at the landscape of available high-quality publications it will still be highly challenging to provide clear recommendations for urological surgeries. The key to a comprehensive application will be the clinical practicality. With this review, the authors have set the stage to a critical review of the recommendations from a urological point of view.

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Daniel Eberli
University and University Hospital of Zurich, Zurich, Switzerland

 

References

 

1 Violette PD, Cartwright R, Briel M, Tikkinen KAO, Guyatt GH. Guideline of guidelines: thromboprophylaxis for urological surgery. BJU Int 2016; 118: 351–58

 

2 Douketis JD, Spyropoulos AC, Spencer FA et al. Perioperative management of antithrombotic therapy: antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl.): e326S–50S

 

3 Steinberg BA, Peterson ED, Kim S et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation 2015; 131: 488–94

 

4 Douketis JD, Spyropoulos AC, Kaatz S et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med 2015; 373: 823–33

 

5 Rose AJ, Allen AL, Minichello T. A call to reduce the use of bridging anticoagulation. Circ Cardiovasc Qual Outcomes 2016; 9: 64–7

 

6 Devereaux PJ, Mrkobrada M, Sessler DI et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med 2014; 370: 1494–503

 

Video: Guideline of Guidelines – Thromboprophylaxis for Urological Surgery

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Guideline of guidelines: thromboprophylaxis for urological surgery

Philippe D. Violette*, Rufus Cartwright†‡, Matthias Briel§, Kari A.O. Tikkinen¶ and Gordon H. Guyatt**,††

 

*Division of Urology, Department of Surgery, Woodstock Hospital, Woodstock, ON, Canada, † Department of Epidemiology and Biostatistics, Imperial College London, London, UK, ‡Department of Urogynaecology, St. Mary’s Hospital, London, UK, §Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland, Departments of Urology and Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland, **Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada, and ††Department of Medicine, McMaster University, Hamilton, ON, Canada
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Decisions regarding thromboprophylaxis in urologic surgery involve a trade-off between decreased risk of venous thromboembolism (VTE) and increased risk of bleeding. Both patient- and procedure-specific factors are critical in making an informed decision on the use of thromboprophylaxis. Our systematic review of the literature revealed that existing guidelines in urology are limited. Recommendations from national and international guidelines often conflict and are largely based on indirect as opposed to procedure-specific evidence. These issues have likely contributed to large variation in the use of VTE prophylaxis within and between countries. The majority of existing guidelines typically suggest prolonged thromboprophylaxis for high-risk abdominal or pelvic surgery, without clear clarification of what these procedures are, for up to 4 weeks post-discharge. Existing guidance may result in the under-treatment of procedures with low risk of bleeding and the over-treatment of oncological procedures with low risk of VTE. Guidance for patients who are already anticoagulated are not specific to urological procedures but generally involve evaluating patient and surgical risks when deciding on bridging therapy. The European Association of Urology Guidelines Office has commissioned an ad hoc guideline panel that will present a formal thromboprophylaxis guideline for specific urological procedures and patient risk factors.
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Article of the Week: Complications after serial prostate biopsies in men on AS

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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.

 

Complications after prostate biopsies in men on active surveillance and its effects on receiving further biopsies in the Prostate cancer Research International: Active Surveillance (PRIAS) study

Leonard P. Bokhorst*, Inari Lepisto†, Yoshiyuki Kakehi‡, Chris H. Bangma*, Tom Pickles§, Riccardo Valdagni¶, Arnout R. Alberts*, Axel Semjonow**, Petra Str
olin††, Manuel F. Montesino‡‡, Viktor Berge§§, Monique J. Roobol* and Antti Rannikko†

*Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands,
†Department of Urology, Helsinki University Central Hospital, Helsinki, Finland,
‡ Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan,
§Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada,
¶Prostate Cancer Program and Radiation Oncology 1, Fondazione IRCSS Istituto Nazionale dei Tumori, Milan, Italy,
**Department of Urology, Prostate Center, University Hospital Muenster, Muenster,
††Department of Urology, Martini Klinik, Hamburg, Germany,
‡‡Department of Urology, Hospital Virgen del Camino, Pamplona, Spain, and
§§Department of Urology, Oslo University Hospital, Oslo, Norway

 

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Objective

To study the risk of serial prostate biopsies on complications in men on active surveillance (AS) and determine the effect of complications on receiving further biopsies.

Patients and methods

In the global Prostate cancer Research International: Active Surveillance (PRIAS) study, men are prospectively followed on AS and repeat prostate biopsies are scheduled at 1, 4, and 7 years after the diagnostic biopsy, or once yearly if prostate-specific antigen-doubling time is <10 years. Data on complications after biopsy, including infection, haematuria, haematospermia, and pain, were retrospectively collected for all biopsies taken during follow-up in men from several large participating centres. Generalised estimating equations were used to test predictors of infection after biopsy. Competing risk analysis was used to compare the rates of men receiving further biopsies between men with and without previous complications.

Results

In all, 2 184 biopsies were taken in 1 164 men. Infection was reported after 55 biopsies (2.5%), and one in five men reported any form of complication. At multivariable analysis, the number of previous biopsies was not a significant predictor of infection (odds ratio 1.04, 95% confidence interval 0.76–1.43). The only significant predictor for infection was the type of prophylaxis used. Of all men with a complication at the diagnostic or first repeat biopsy, 21% did not have a repeat biopsy at the time a repeat biopsy was scheduled according to protocol, vs 12% for men without a previous biopsy complication.

aotwsept-1

Conclusion

In our present cohort of men on AS, we found no evidence that repeat prostate biopsy in itself posed a risk of infection. However, complications after biopsy were not uncommon and after a complication men were less likely to have further biopsies. We should aim to safely reduce the amount of repeat biopsies in men on AS.

 

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Editorial: Active surveillance for prostate cancer: is it too active?

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The wide dissemination of prostate cancer screening has increased the number of men diagnosed with low-risk, indolent cancers that are better managed with active surveillance (AS) rather than immediate treatment. During the past decade, the number of men managed with AS has increased from <10% to 40% in community based practice registries [1]. Prostate needle biopsy has a central role in diagnosis and reclassification of cancer for men on AS, and the number of these procedures has increased on an individual patient level and overall in the population. The rise of prostate biopsies repeated in the same patients has mirrored the increased rate of biopsy related infectious complications. An association between the number of repeat prostate biopsies and risk of infectious complications was reported in a single-centre observational study [2].

In this issue of BJUI, Bokhort et al. [3] report the risk of complications of serial prostate biopsies in men on AS in the multi-institutional Prostate cancer Research International Active Surveillance (PRIAS) study. Although they did not identify the number of previous biopsies as an independent predictor of infection, the type of prophylactic antibiotic was associated with risk of infection. Overall, one in five men reported any complication during AS and the rate of infectious complications was 2.5%. These figures are more relevant if we consider that men in whom an infection occurred were twice as likely to discontinue AS. Although the rate of attrition may have confounded the association of repeat biopsies on infectious complications or guided a more augmented antibiotic prophylaxis regimen, the most important finding of this study remains the significant morbidity associated with AS.

In the PRIAS study, institutions are guided to perform surveillance biopsies at 1, 4, and 7 years after the diagnostic biopsy. However, the schedule of biopsies varies significantly globally across institutions. In some academic centres, prostate biopsies are taken annually for men on AS, while other experts in AS have discussed taking biopsies every 5 years [4, 5]. As more studies emerge demonstrating the oncological safety of AS, we must address how ‘active’ AS should be and develop individualised recommendations based on tumour characteristics. A barrier to AS remains the burden of morbidity associated with prostate biopsies and efforts to reduce these procedures will contribute to further reducing the overtreatment of men with low-risk prostate cancer. In addition, the patient costs associated with serial office visits and the burden on physicians and healthcare systems stemming from the increased clinical volume following these patients remain an unmet need for the future.

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Behfar Ehdaie
Department of Surgery, Urology Service, and Department of Epidemiology and Biostatistics, Center of Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY, USA

 

References

1. Cooperberg MR, Carroll PR. Trends in management for patients with localized prostate cancer, 1990–2013. JAMA 2015; 314: 80–2

2. Ehdaie B, Vertosick E, Spaliviero M et al. The impact of repeat biopsies on infectious complications in men with prostate cancer on active surveillance. J Urol 2014; 191: 660–4

3. Bokhorst LP, Lepistö I, Kakehi Y et al. Complications after prostate biopsies in men on active surveillance and its effects on receiving further biopsies in the Prostate cancer Research International: Active Surveillance (PRIAS) study. BJU Int 2016; 118: 366–71

4. Tosoian JJ, Mamawala M, Epstein JI et al. Intermediate and longer-term outcomes from a prospective active-surveillance program for favorable-risk prostate cancer. J Clin Oncol 2015; 33: 3379–85

5. Klotz L. Active surveillance: current and future directions. Curr Opin Urol 2013; 23: 237–8

 

 

Article of the Week: Multicentre outcomes of robot-assisted partial nephrectomy after major open abdominal surgery

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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 Craig Rogers, discussing his paper.

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

Multicentre outcomes of robot-assisted partial nephrectomy after major open abdominal surgery

 

Newaj Abdullah*, Haider Rahbar*, Ravi Barod*, Deepansh Dalela*, Jeff Larson†, Michael Johnson‡, Alon Mass§, Homayoun Zargar, Mohamad Allaf‡, Sam Bhayani†, Michael Stifelman§, Jihad Kaouk¶ and Craig Rogers*

 

*Vattikutti Urology Institute, Henry Ford Health System, Detroit, MI, †Division of Urology, Washington University in St. Louis, St. Louis, MO, ‡James Buchanan Brady Urological Institute, John Hopkins University, Baltimore, MD, §Department of Urology, New York University, New York, NY, and Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA

 

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Objective

To evaluate the outcomes of robot-assisted partial nephrectomy RAPN after major prior abdominal surgery (PAS) using a large multicentre database.

Patients and methods

We identified 1 686 RAPN from five academic centres between 2006 and 2014. In all, 216 patients had previously undergone major PAS, defined as having an open upper midline/ipsilateral incision. Perioperative outcomes were compared with those 1 470 patients who had had no major PAS. The chi-squared test and Mann–Whitney U-test were used for categorical and continuous variables, respectively.

AugAOTW4FI

Results

There was no statistically significant difference in Charlson comorbidity index, tumour size, R.E.N.A.L. nephrometry score or preoperative estimated glomerular filtration rate (eGFR) between the groups. Age and body mass index were higher in patients with PAS. The PAS group had a higher estimated blood loss (EBL) but this did not lead to a higher transfusion rate. A retroperitoneal approach was used more often in patients with major PAS (11.2 vs 5.4%), although this group did not have a higher percentage of posterior tumours (38.8 vs 43.3%, P = 0.286). Operative time, warm ischaemia time, length of stay, positive surgical margin, percentage change in eGFR, and perioperative complications were not significantly different between the groups.

Conclusions

RAPN in patients with major PAS is safe and feasible, with increased EBL but no increased rate of transfusion. Patients with major PAS had almost twice the likelihood of having a retroperitoneal approach.

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Video: Multicentre outcomes of robot-assisted partial nephrectomy after major open abdominal surgery

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Multicentre outcomes of robot-assisted partial nephrectomy after major open abdominal surgery

Newaj Abdullah*, Haider Rahbar*, Ravi Barod*, Deepansh Dalela*, Jeff Larson†, Michael Johnson‡, Alon Mass§, Homayoun Zargar, Mohamad Allaf‡, Sam Bhayani†, Michael Stifelman§, Jihad Kaouk¶ and Craig Rogers*

 

*Vattikutti Urology Institute, Henry Ford Health System, Detroit, MI, †Division of Urology, Washington University in St. Louis, St. Louis, MO, ‡James Buchanan Brady Urological Institute, John Hopkins University, Baltimore, MD, §Department of Urology, New York University, New York, NY, and Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA

 

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Objective

To evaluate the outcomes of robot-assisted partial nephrectomy RAPN after major prior abdominal surgery (PAS) using a large multicentre database.

Patients and methods

We identified 1 686 RAPN from five academic centres between 2006 and 2014. In all, 216 patients had previously undergone major PAS, defined as having an open upper midline/ipsilateral incision. Perioperative outcomes were compared with those 1 470 patients who had had no major PAS. The chi-squared test and Mann–Whitney U-test were used for categorical and continuous variables, respectively.

AugAOTW4FI

Results

There was no statistically significant difference in Charlson comorbidity index, tumour size, R.E.N.A.L. nephrometry score or preoperative estimated glomerular filtration rate (eGFR) between the groups. Age and body mass index were higher in patients with PAS. The PAS group had a higher estimated blood loss (EBL) but this did not lead to a higher transfusion rate. A retroperitoneal approach was used more often in patients with major PAS (11.2 vs 5.4%), although this group did not have a higher percentage of posterior tumours (38.8 vs 43.3%, P = 0.286). Operative time, warm ischaemia time, length of stay, positive surgical margin, percentage change in eGFR, and perioperative complications were not significantly different between the groups.

Conclusions

RAPN in patients with major PAS is safe and feasible, with increased EBL but no increased rate of transfusion. Patients with major PAS had almost twice the likelihood of having a retroperitoneal approach.

Read more articles of the week

Article of the Week: LAPPRO trial – Oncological and Functional Outcomes 1 Year after RP for Very-Low-Risk 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 Dr. Stefan Carlsson, Dr. Anna Wallerstedt and Dr Rodolfo Sanchez, discussing their paper.

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

Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial

Stefan Carlsson*, Fredrik Jaderling†, Anna Wallerstedt*, Tommy Nyberg‡, Johan Stranne§
, Thordis Thorsteinsdottir, Sigrid V. Carlsson**, Anders Bjartell††, Jonas Hugosson§, Eva Haglind‡‡ and Gunnar Steineck‡,§§

 

*Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, †Department of Molecular Medicine and Surgery, Section of Radiology, Karolinska Institutet, ‡Department of Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, §Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Faculty of Nursing, School of Health Sciences, University of Iceland, Iceland, **Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA, ††Department of Urology, Skane University Hospital, Lund University, Lund, ‡‡ Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, and §§Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

 

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Carlsson-et-al-infographic-cropped

 

Click on image for full size infographic

 

Objectives

To analyse oncological and functional outcomes 12 months after treatment of very-low-risk prostate cancer with radical prostatectomy in men who could have been candidates for active surveillance.

Patients and Methods

We conducted a prospective study of all men with very-low-risk prostate cancer who underwent radical prostatectomy at one of 14 participating centres. Validated patient questionnaires were collected at baseline and after 12 months by independent healthcare researchers. Biochemical recurrence (BCR) was defined as prostate-specific antigen (PSA) ≥0.25 ng/mL or treatment with salvage radiotherapy or with hormones. Urinary continence was defined as <1 pad changed per 24 h. Erectile function was defined as ability to achieve erection hard enough for penetration more than half of the time after sexual stimulation. Changes in tumour grade and stage were obtained from pathology reports. We report descriptive frequencies and proportions of men who had each outcome in various subgroups. Fisher’s exact test was used to assess differences between the age groups.

AugAOTW3Results

Results

Of the 4003 men in the LAPPRO cohort, 338 men fulfilled the preoperative national criteria for very-low-risk prostate cancer. Adverse pathology outcomes included upgrading, defined as pT3 or postoperative Gleason sum ≥7, which was present in 35% of the men (115/333) and positive surgical margins, which were present in 16% of the men (54/329). Only 2.1% of the men (7/329) had a PSA concentration >0.1 ng/mL 6–12 weeks postoperatively. Erectile function and urinary continence were observed in 44% (98/222) and 84% of the men (264/315), respectively, 12 months postoperatively. The proportion of men achieving the trifecta, defined as preoperative potent and continent men who remained potent and continent with no BCR, was 38% (84/221 men) at 12 months.

Conclusions

Our prospective study of men with very-low-risk prostate cancer undergoing open or robot-assisted radical prostatectomy showed that there were favourable oncological outcomes in approximately two-thirds. Approximately 40% did not have surgically induced urinary incontinence or erectile dysfunction 12 months postoperatively. These results provide additional support for the use of active surveillance in men with very-low-risk prostate cancer; however, the number of men with risk of upgrading and upstaging is not negligible. Improved stratification is still urgently needed.

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Editorial: Management Dilemmas in Low-Risk Prostate Cancer

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Prostate cancer is the most commonly diagnosed solid organ tumour and the second leading cause of cancer death in men in the USA. The exact path of these tumours from inception to metastasis is unclear; the same can also be said for those tumours that remain indolent. The varying genetic signatures of these tumours is the underlying determinant of the outcomes of these cancers and therein lies the key to selecting patients that do and do not need treatment for their prostate cancers. Most low-risk tumours are relatively indolent; however, some low-risk tumours have the potential to metastasise and cause mortality. The problem is that currently we do not have the ability to accurately and confidently determine the tumour’s individual risk profiles.

In the recent LAPPRO trial (LAParoscopic Prostatectomy Robot Open – a randomised, open trial of radical prostatectomy (RP) with or without lymph node dissection as part of a prospective, non-randomised, open trial comparing robot-assisted laparoscopic and open RP), the authors reported the RP results of patients with very-low-risk prostate cancer in a population-based study from Sweden compiling the results of open and laparoscopic RP over 14 centres of varying experience [1]. They reported pathological upgrading in 35% of patients and PSA recurrence in 2.1%. Functional outcomes at 1 year featured urinary continence levels of 84% and sexual potency of 44%. The overall trifecta rate at 1 year was 38%. What is important to note is that only 56% had optimal erectile function preoperatively (Sexual Health Inventory for Men score >21) and that it is unknown which patients received a full nerve preservation. Also the amount of postoperative continence and potency rehabilitation is unknown.

The results of the LAPPRO trial are not too dissimilar to data from the Medicare database publications on RP, which also take into account large populations of patients operated on at multiple institutions with variable surgical experience and volume [2]. The challenge with interpreting these data is that they often are quite variable based upon the preoperative status of the patient, type of surgery performed, surgeon experience, and institutional volumes [3]. If you compare the Medicare data or LAPPRO trial outcomes to large-volume single-surgeon series you often will see wide variances in outcomes favouring the single-surgeon experience. Single-surgeon and large-volume series have reported better outcomes often due to improved surgical experience, techniques, and outcomes overall [4].

Active surveillance is usually the primary choice for management of low- and very-low-risk prostate cancer lesions. However, some patients do still chose to undergo surgery due to personal choice, often related to the uncertainty associated with the diagnosis and the unknown risk of progression [5]. One would assume that low-risk tumours have a low risk of progression and metastasis; however, this is not always the case due to the varying genetic signature of the individual tumours. Also, recent studies have shown that in patients diagnosed with low-risk prostate cancer 30–50% have non-low-risk disease harbouring intermediate- or high-risk prostate cancer instead [1, 6]. This uncertainty on the part of the patient and physician can cause anxiety in patients and sometime influence their decision for treatment [7].

One would assume that patients with low- and very-low-risk patients are ideal candidates for the trifecta due to low tumour aggressiveness and volume. However, many factors influence patient outcome beyond the characteristics of the tumour. Preoperative features such as co-morbidities and pre-existing sexual dysfunction or incontinence are influential. Operative and postoperative factors include: surgeon experience, institutional volume, patients body habitus, number of prior biopsies, the ability to fully spare the nerves, and various other challenges during surgery. These are all variables that must be considered when projecting the success of surgical intervention.

While the results of surgery in the LAPPRO trial were not encouraging for surgery, we do have to take the results in context and not apply them broadly or globally without some thought. The results are blurred by combining open and laparoscopic RP, many patients were not optimal candidates’ preoperatively for the trifecta, many did not have a full nerve preservation and also many different institutions with varying levels of surgeon experience are analysed. This population was also ‘captive’, as they had to choose surgeons in their own locality, these ‘local’ surgeons may not have had the necessary experience or technique to achieve optimal outcomes. The conclusion that can be drawn is that if you sample a broad population of surgeons then the results are often quite poor due to the varying levels of skill of the surgeon and the varying level of surgical volume and experience. What the patients should glean from this is the fact that they should consider active surveillance for these types of tumours to avoid the associated morbidity. In addition, if they were to seek therapy they should select centres with higher surgical experience and proven outcomes.

For those patients that have low-risk tumours and seek treatment; judicious counselling of expectations must be performed by their healthcare advocate. Both the patient and physician must take the responsibility in making the correct assumptions and decisions. The physician must re-emphasise the available data and the low likelihood of progression in these tumours adding some caution from the fact that some of these may be upgraded. Patients must be given accurate data in the correct context. Most patients who have treatment for prostate cancer whether it be radiation, ablation or removal have a high chance of some deficit in the quality of life, functional recovery of urinary continence, and sexual potency. Educating the patient and managing realistic expectations is often the most important factor in patient satisfaction. Patients must take into account their own preoperative medical and functional status to properly stratify expectations.

If these patients after appropriate counselling are still intent to undergo surgery they should consider seeking centres with high-volume and individualised surgeons with proven quality outcomes. Large-volume single-surgeon series do show improvements in the trifecta outcomes [4]. However, none have shown perfect trifecta rates. No matter what method of treatment patients chose there would be some varying level of loss of functional outcome. The balance between cancer progression and quality of life must be weighted. For low-risk patients, we need to have a better road map of the genetic signatures of their tumour and only then will we be able to confidently tell our patients who will and who will not have the potential to harbour high-risk disease and potentially have mortality from the tumour. Until we are able to confidently deliver this information to the patient, many with low-risk disease will still seek treatment and endanger their quality of life. The recent increase in the availability of biomarkers to examine prostate biopsy specimens for risk stratification is encouraging, yet still in its infancy. Further study of these biomarkers will enhance our ability to read the genetic signature of prostate cancers at an early state and more appropriately risks stratify our patients.

The LAPPRO trial supports active surveillance as the primary choice for low- and very-low-risk tumours. However, their results are exclusive to their patient population and level of surgical experience. A similar trial with a high-volume experienced surgeon would undoubtedly show more optimistic results. Managing reasonable expectations, risk stratification, and picking expertise and experience, often makes the difference between a good and poor outcome.

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Vipul R. Patel*† and Hariharan Palayapalayam Ganapathi*†
*Global Robotics Institute, Florida Hospital Celebration Health, and †University of Central Florida School of Medicine, Orlando, FL, USA

 

References

 

1 Carlsson S, Jaderling F, Wallerstedt A et al. Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial. BJU Int 2016; 118: 205–12

 

2 Barry MJ, Gallagher PM, Skinner JS, Fowler FJ Jr. Adverse effects of robotic-assisted laparoscopic versus open retropubic radical prostatectomy among a nationwide random sample of Medicare-age men. J Clin Oncol 2012; 30: 513–8

 

3 Patel VR, Abdul-Muhsin HM, Schatloff O et al. Critical review of ‘pentafecta’ outcomes after robot-assisted laparoscopic prostatectomy in high-volume centres. BJU Int 2011; 108: 1007–17

 

4 Patel VR, Coelho RF, Chauhan S et al. Continence, potency and oncological outcomes after robotic-assisted radical prostatectomy: early trifecta results of a high-volume surgeon. BJU Int 2010; 106: 696–702

 

5 Simpkin AJ, Tilling K, Martin RM et al. Systematic review and meta-analysis of factors determining change to radical treatment in active surveillance for localized prostate cancer. Eur Urol 2015; 67: 993–1005

 

6 El Hajj A, Ploussard G, de la Taille A et al. Analysis of outcomes after radical prostatectomy in patients eligible for active surveillance (PRIAS). BJU Int 2013; 111: 53–9

 

7 Van den Bergh RC, Essink-Bot ML, Roobol MJ et al. Anxiety and distress during active surveillance for early prostate cancer. Cancer 2009; 115: 3868–78

 

Video: LAPPRO trial – Oncological and Functional Outcomes 1 Year after RP for Very-Low-Risk PCa

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Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial

Stefan Carlsson*, Fredrik Jaderling†, Anna Wallerstedt*, Tommy Nyberg‡, Johan Stranne§
, Thordis Thorsteinsdottir, Sigrid V. Carlsson**, Anders Bjartell††, Jonas Hugosson§, Eva Haglind‡‡ and Gunnar Steineck‡,§§

 

*Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, †Department of Molecular Medicine and Surgery, Section of Radiology, Karolinska Institutet, ‡Department of Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Stockholm, §Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Faculty of Nursing, School of Health Sciences, University of Iceland, Iceland, **Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA, ††Department of Urology, Skane University Hospital, Lund University, Lund, ‡‡ Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, and §§Division of Clinical Cancer Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

 

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Objectives

To analyse oncological and functional outcomes 12 months after treatment of very-low-risk prostate cancer with radical prostatectomy in men who could have been candidates for active surveillance.

Patients and Methods

We conducted a prospective study of all men with very-low-risk prostate cancer who underwent radical prostatectomy at one of 14 participating centres. Validated patient questionnaires were collected at baseline and after 12 months by independent healthcare researchers. Biochemical recurrence (BCR) was defined as prostate-specific antigen (PSA) ≥0.25 ng/mL or treatment with salvage radiotherapy or with hormones. Urinary continence was defined as <1 pad changed per 24 h. Erectile function was defined as ability to achieve erection hard enough for penetration more than half of the time after sexual stimulation. Changes in tumour grade and stage were obtained from pathology reports. We report descriptive frequencies and proportions of men who had each outcome in various subgroups. Fisher’s exact test was used to assess differences between the age groups.

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Results

Of the 4003 men in the LAPPRO cohort, 338 men fulfilled the preoperative national criteria for very-low-risk prostate cancer. Adverse pathology outcomes included upgrading, defined as pT3 or postoperative Gleason sum ≥7, which was present in 35% of the men (115/333) and positive surgical margins, which were present in 16% of the men (54/329). Only 2.1% of the men (7/329) had a PSA concentration >0.1 ng/mL 6–12 weeks postoperatively. Erectile function and urinary continence were observed in 44% (98/222) and 84% of the men (264/315), respectively, 12 months postoperatively. The proportion of men achieving the trifecta, defined as preoperative potent and continent men who remained potent and continent with no BCR, was 38% (84/221 men) at 12 months.

Conclusions

Our prospective study of men with very-low-risk prostate cancer undergoing open or robot-assisted radical prostatectomy showed that there were favourable oncological outcomes in approximately two-thirds. Approximately 40% did not have surgically induced urinary incontinence or erectile dysfunction 12 months postoperatively. These results provide additional support for the use of active surveillance in men with very-low-risk prostate cancer; however, the number of men with risk of upgrading and upstaging is not negligible. Improved stratification is still urgently needed.

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Article of the Week: eNOS G894T gene polymorphism and responsiveness to a selective α1-blocker in BPH/LUTS

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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.

The association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective α1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms

Yung-Chin Lee*,†, Yung-Shun Juan*,†,‡, Chia-Chu Liu*,†,§, Bo-Ying Bao,**,††, Chii-Jye
Wang*,†, Wen-Jeng Wu*,†, Chun-Nung Huang*,† and Shu-Pin Huang*,†,‡‡
*Department of Urology, †Department of Urology, Faculty of Medicine, Kaohsiung Medical University, ‡Department of Urology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, §Department of Health, Executive Yuan, Pingtung Hospital, Pingtung,

 

Department of Pharmacy, **Sex Hormone Research Center, China Medical University Hospital, ††Department of Nursing, Asia University, Taichung, and ‡‡Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
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Objective

To prospectively investigate the association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective α1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms (BPH/LUTS), as nitric oxide has recently gained increasing recognition as an important neurotransmitter of functions in the lower urinary tract.

Patients and Methods

In all, 136 men with BPH/LUTS were recruited from urology outpatient clinics in a university hospital. Oral therapy with doxazosin gastrointestinal therapeutic system (GITS) 4 mg once-daily was given for 12 weeks. The drug efficacy was assessed by the changes from baseline in the total International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR) at 12 weeks of treatment. The ‘responders’ to doxazosin GITS were defined as those who had a total IPSS decrease of >4 points from baseline. eNOS G894T polymorphism was determined using the polymerase chain reaction-restriction fragment length polymorphism method.

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Results

Patients had statistically significant improvements in total IPSS, quality of life score, and Qmax (P < 0.01) after a 12-week period of treatment. Using multiple logistic regression analysis adjusted for age and IPSS, our results showed that being a eNOS 894T allele carrier was an independent risk factor for being a drug non-responder (P = 0.03, odds ratio 4.19). Moreover, a decreased responder rate (P = 0.01), as well as the lower improvements in IPSS (P = 0.02) and Qmax (P = 0.03) were significantly associated with increment in the T allele number.

Conclusions

The presence of the eNOS 894T allele had a significantly negative impact on responsiveness to a selective α1-blocker in BPH/LUTS treatment, suggesting that eNOS G894T gene polymorphism may be a genetic susceptibility factor for α1-blocker efficacy in men with BPH/LUTS.

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