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Article of the Month: Retzius-sparing RARP using the Revo-i: results of the first human trial

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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.

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

Retzius-sparing robot-assisted radical prostatectomy using the Revo-i robotic surgical system: surgical technique and results of the first human trial

 

Ki Don Chang*†, Ali Abdel Raheem*‡, Young Deuk Choi* , Byung Ha Chung* and Koon Ho Rha*

*Department of Urological Science Institute, Yonsei University College of Medicine, Seoul, †Department of Urology, Urological Science Institute, Yonsei Wonju University College of Medicine, Wonju, Korea, and ‡Department of Urology, Tanta University Medical School, Tanta, Egypt

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Abstract

Objective

To evaluate the safety and proficiency of the Revo‐i® robotic platform (Meere Company Inc.) in the treatment of prostate cancer (PCa).

Patients and Methods

A prospective study was carried out on 17 patients with clinically localized PCa treated between 17 August 2016 and 23 February 2017 at our urology department using the Revo‐i. Patients underwent Retzius‐sparing robot‐assisted radical prostatectomy (RS‐RARP). The primary objective was to describe the RS‐RARP step‐by‐step surgical technique using the Revo‐i. In addition, the safety of the Revo‐i was assessed according to intra‐operative and the postoperative complications within 30 days of surgery. Early oncological outcomes were also assessed according to surgical margin status and biochemical recurrence (BCR). Continence was defined as use of no or only one pad. Surgeons’ satisfaction with the Revo‐i was assessed using the Likert scale.

Results

All surgeries were completed successfully, with no conversion to open or laparoscopic surgery. The median patient age was 72 years. The median docking time, console time, urethrovesical anastomosis time and estimated blood loss were 8 min, 92 min, 26 min and 200 mL, respectively. One patient was transfused intra‐operatively as a result of blood loss of 1 500 mL. Postoperatively, two patients received blood transfusion, and there were no other serious/major complications. The median hospital stay was 4 days. At 3 months, four patients had positive surgical margins, one patient had BCR, and 15 patients were continent. Most of surgeons were satisfied with the Revo‐i performance.

Conclusions

The first human study for the treatment of patients with localized PCa using the Revo‐i robotic surgical system was carried out successfully. The peri‐operative, early oncological and continence outcomes are encouraging. Further prospective studies are warranted to support our preliminary results.

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Article of the Week: NICE Advice – Prolaris Gene Expression Assay

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Every Week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The summary 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.

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

NICE Advice – Prolaris gene expression assay for assessing long‐term risk of prostate cancer progression

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Article of the Week: Performance comparison of two AR-V7 detection methods

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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.

Performance comparison of two androgen receptor splice variant 7 (AR‐V7) detection methods

Christof Bernemann* , Julie Steinestel*, Verena Humberg*, Martin Bogemann*, € Andres Jan Schrader* and Jochen K. Lennerz†

*Urology, University of Muenster Medical Center, Muenster, Germany, and † Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA

 

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Abstract

Objectives

To compare the performance of two established androgen receptor splice variant 7 (AR‐V7) mRNA detection systems, as paradoxical responses to next‐generation androgen‐deprivation therapy in AR‐V7 mRNA‐positive circulating tumour cells (CTC) of patients with castration‐resistant prostate cancer (CRPC) could be related to false‐positive classification using detection systems with different sensitivities.

Materials and Methods

We compared the performance of two established mRNA‐based AR‐V7 detection technologies using either SYBR Green or TaqMan chemistries. We assessed in vitro performance using eight genitourinary cancer cell lines and serial dilutions in three AR‐V7‐positive prostate cancer cell lines using even 2D barcoded tubes as well as in 32 blood samples from patients with CRPC.

Results

Both assays performed identically in the cell lines and serial dilutions showed identical diagnostic thresholds. Performance comparison in 32 clinical patient samples showed perfect concordance between the assays. In particular, both assays determined AR‐V7 mRNA‐positive CTCs in three patients with unexpected responses to next‐generation anti‐androgen therapy. Thus, technical differences between the assays can be excluded as the underlying reason for the unexpected responses to next‐generation anti‐androgen therapy in a subset of AR‐V7 patients.

Conclusions

Irrespective of the method used, patients with AR‐V7 mRNA‐positive CRPC should not be systematically precluded from an otherwise safe treatment option.

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Editorial: The way towards understanding possible multiple functions of AR V7 in prostate cancer

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The presence of constitutively active androgen receptors in castration therapy‐resistant prostate cancer is frequently associated with therapy resistance. This is not surprising because the transcriptional program of these receptors is not dependent on the presence of circulating androgen. In conditions of reduced expression of circulating androgen, functional activity of the receptor probably contributes to cancer progression. Investigations by Bernemann et al. [1, 2], however, showed that some patients who present with variant ARV7, the most frequently diagnosed variant receptor, still respond to second‐generation anti‐androgen therapy. Until publication of the paper by Bernemann et al. [1], it was not completely clear whether “any findings in this area” reflected a technical error. The authors report further technical advances and similar detection of variant androgen receptors with two PCR assays, the SYBR Green and TaqMan assays. These advances in detection may open up a new area of investigation. The study reported in the current issue of BJUI may therefore shed more light on biology of truncated androgen receptors in prostate cancer [1]. According to the initial seminal publication in the field, AR‐V7‐positive patients had lower endocrine therapy response rates than those who were variant‐negative [3]. Studies aiming to detect variant androgen receptors are particularly important because of increasing interest in circulating tumour cells in prostate cancer [4]. It may be necessary to better describe subgroups of AR‐V7 which may differ in interactions with specific coactivators. Overall, relatively little is known about alterations in interactions between coactivators and the N‐terminal region of the receptor that may occur in subgroups of patients with castration therapy‐resistant prostate cancer [5]. Several important questions regarding signalling between the wild‐type and constitutively active androgen receptor have not been completely clarified, and the issue of which genes are regulated by both receptors is still a matter of discussion. The findings presented in the study by Bernemann et al. [1] may represent the next step towards individualization of therapies. If we accept that variant androgen receptors also display heterogeneity, a more differentiated classification of those receptors may guide clinical decisions in the future. Future studies should also take into consideration the fact that different variants may be expressed at different levels during and after endocrine therapy. These ratios of androgen receptor variant expression may be taken into consideration when determining the probability of success of specific anti‐androgen receptor therapy. One could also learn that application of different methodologies in variant androgen receptor diagnostics may become an established standard in monitoring castration therapy‐resistant disease. Establishment of controlled standard operating procedures in PCR diagnostics may at this stage minimize discrepancies between findings reported by different researchers and help to establish a consensus on this important topic.

Zoran Culig

Experimental Urology, Department of Urology, Medical University of Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria

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References

  1. Bernemann C, Steinestel J, Humberg V, Bögemann M, Schrader AJ, Lennerz JK. Performance comparison of two AR‐V7 detection methods. BJU Int 2018; 122: 219–26

 

Article of the Week: Cost‐effectiveness of MRI and targeted fusion biopsy for early detection of prostate cancer

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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.

Cost‐effectiveness of magnetic resonance imaging and targeted fusion biopsy for early detection of prostate cancer

Christine L. Barnett* , Matthew S. Davenport†, Jeffrey S. Montgomery‡, John T. Wei‡, James E. Montie‡ and Brian T. Denton*‡

 

*Departments of Industrial and Operations Engineering, †Radiology, and ‡Urology, University of Michigan, Ann Arbor, MI, USA

 

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Objective

To determine how best to use magnetic resonance imaging (MRI) and targeted MRI/ultrasonography fusion biopsy for early detection of prostate cancer (PCa) in men with elevated prostate‐specific antigen (PSA) concentrations and whether it can be cost‐effective.

Methods

A Markov model of PCa onset and progression was developed to estimate the health and economic consequences of PCa screening with MRI. Patients underwent PSA screening from ages 55 to 69 years. Patients with elevated PSA concentrations (>4 ng/mL) underwent MRI, followed by targeted fusion or combined (standard + targeted fusion) biopsy on positive MRI, and standard or no biopsy on negative MRI. Prostate Imaging Reporting and Data System (PI‐RADS) score on MRI was used to determine biopsy decisions. Deaths averted, quality‐adjusted life‐years (QALYs), cost and incremental cost‐effectiveness ratio (ICER) were estimated for each strategy.


Results

With a negative MRI, standard biopsy was more expensive and had lower QALYs than performing no biopsy. The optimum screening strategy (ICER $23 483/QALY) recommended combined biopsy for patients with PI‐RADS score ≥3 and no biopsy for patients with PI‐RADS score <3, and reduced the number of screening biopsies by 15%. Threshold analysis suggests MRI continues to be cost‐effective when the sensitivity and specificity of MRI and combined biopsy are simultaneously reduced by 19 percentage points.

Conclusions

Our analysis suggests MRI followed by targeted MRI/ultrasonography fusion biopsy can be a cost‐effective approach to the early detection of PCa.

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Editorial: MRI with targeted fusion biopsy: is the time now?

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The current standard of performing TRUS‐guided systematic biopsy in men with a PSA of 4–10 ng/mL results in a considerable number of unnecessary prostate biopsies and overtreatment of clinically indolent disease, both of which are costly from the patient and healthcare system perspectives [1]. Two recent studies document that incorporating multiparametric (mp)MRI into prostate cancer screening has the potential to reduce overdiagnosis and overtreatment. Ahmed et al. [2] performed mpMRI followed by TRUS biopsy and template prostate mapping biopsy in 576 men with a PSA level of 4–14 ng/mL or an abnormal DRE. They found that using mpMRI to triage men would result in 27% fewer men undergoing biopsy while diagnosing 5% fewer clinically insignificant cancers. Furthermore, if subsequent TRUS biopsies were directed by mpMRI findings, 18% more cases of clinically significant cancer might be detected compared with traditional screening biopsies. Using a similar randomized study design, Kasivisvanathan et al. [3] found the use of mpMRI for screening reduced the biopsy rate by 28%, while lowering the rate of clinically insignificant cancer by 13% and improving the detection rate of clinically significant cancer by 12% [3]. While the addition of mpMRI to the screening armamentarium clearly provides clinical value, it also adds considerable increased costs, begging the question: is it worth it?

In the current issue of BJUI, Barnett et al. [1] evaluated the cost‐effectiveness of prostate MRI in a screening setting in order to determine whether MRI may be able to mitigate prostate biopsies in biopsy‐naïve men with a negative imaging study. They found that, when using the generally accepted threshold of $100 000/quality‐adjusted life year (QALY), the most cost‐efficient strategy consisted of obtaining prostate MRI in men with PSA >4 mg/mL. This was followed by either systematic and targeted fusion biopsy if the MRI showed a Prostate Imaging Reporting and Data System (PI‐RADS) score ≥3 lesion or continued observation if the MRI did not show a PI‐RADS score ≥3 lesion. Altogether, this strategy resulted in 5.9 prostate cancer deaths averted, 60.7 QALYs gained, and 72.6 life‐years gained for every 1000 patients screened. The number‐needed‐to‐treat to prevent one prostate cancer death with this approach was 169.

While the results are informative, the reader should interpret the study’s findings carefully as there is not agreement among policy makers on what is the optimal incremental willingness‐to‐pay threshold to determine what is truly cost‐effective. Furthermore, this study does not address the potential negative impact that detection of clinically insignificant prostate cancer may have on health‐state utilities and quality of life. Barnett et al. also predominantly obtained costs from Medicare data, but as previously reported, these costs are often rough estimates that are derived more from revenue or reimbursement than from the true cost of treating the disease process. The cost‐effectiveness estimates presented in this report, therefore, will probably vary from country to country. To examine the true cost, Laviana et al. [4] previously explored the cost of prostate MRI using time‐driven activity‐based costing and found the cost of MRI and mpMRI/TRUS to be $670 and $1,072 US dollars, respectively. These are significantly cheaper than the Medicare reported costs of $964.21 and $3,019.35 for MRI and mpMRI/TRUS, respectively. This implies that MRI and targeted biopsy may actually be even more cost‐effective than reported in the present study.

We must remember that, while the present study shows that MRI in prostate cancer screening may be cost‐effective, the base case population only included men with a PSA >4 mg/mL. This study does not address the cost‐effectiveness of a screening MRI in the larger population of all men at risk of prostate cancer, although previous data by Nam et al. [5] suggest MRI may be a potentially better primary screening tool than PSA. Of course, population‐wide prostate MRI screening would result in greatly increased upfront costs and, as such, the strategy would first need to be proven cost‐effective before MRI could replace PSA as the front‐line test in prostate cancer screening.

In conclusion, Burnett et al. elegantly demonstrate that an upfront MRI, in men with a PSA of >4 ng/mL, may ultimately be a cost‐effective approach depending on your willingness‐to‐pay threshold. Policymakers and payers worldwide should recognize that prostate MRI is here to stay and should be made more widely available to those with a PSA >4 ng/mL who are at risk of prostate cancer.

Aaron A. Laviana* and David F. Penson*†
*Department of Urological Surgery, Vanderbilt University, and †VA Tennessee Valley Geriatric Research, Education and Clinical Centre, Nashville, TN, USA

 

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References
  1. Barnett C, Davenport M, Montgomery J et al. Cost‐effectiveness of magnetic resonance imaging and targeted fusion biopsy for early detection of prostate cancer. BJU Int 2018; 122: 50–8
  2. Ahmed HU, El‐Shater BA, Brown LC et al. Diagnostic accuracy of multi‐parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017; 389: 815–22
  3. Kasivisvanathan V, Rannikko AS, Borghi M et al. MRI‐targeted or standard biopsy for prostate‐cancer diagnosis. N Engl J Med 2018; 378: 1767-77
  4. Laviana AA, Ilg AM, Veruttipong D et al. Utilizing time‐driven activity‐based costing to understand the short‐ and long‐term costs of treating localized, low‐risk prostate cancer. Cancer 2016; 122: 447–55
  5. Nam RK, Wallis CJD, Stojcic‐Bendavid J et al. A pilot study to evaluate the role of magnetic resonance imaging for prostate cancer screening in the general population. J Urol 2016; 192: 361–6

 

Article of the Month: MRI supported transperineal prostate biopsy

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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.

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

Multicentre evaluation of magnetic resonance imaging supported transperineal prostate biopsy in biopsy‐naïve men with suspicion of prostate cancer

 

Nienke L. Hansen*1, Tristan Barrett*†, Claudia Kesch‡, Lana Pepdjonovic§, David Bonekamp, Richard O’Sullivan**, Florian Distler‡, Anne Warren*††, Christina Samel‡‡, Boris Hadaschik‡2, Jeremy Grummet§ and Christof Kastner*§§
*CamPARI Clinic, †Department of Radiology, Addenbrooke’s Hospital and University of Cambridge, Cambridge, UK, ‡Department of Urology, University Hospital Heidelberg, Heidelberg, Germany, §Australian Urology Associates and Department of Surgery, Central Clinical School, Monash University, Melbourne, Vic., Australia, Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg, Germany, **Healthcare Imaging and Monash University, Melbourne, Vic., Australia, ††Department of Pathology, Addenbrooke’s Hospital and University of Cambridge, Cambridge, UK, ‡‡Institute of Medical Statistics, Informatics and Epidemiology, University Hospital Cologne, Cologne, Germany, and §§Department of Urology, Addenbrooke’s Hospital and University of Cambridge, Cambridge, UK 

 

Current addresses: 1Department of Diagnostic and Interventional Radiology University Hospital Cologne Cologne Germany, 2Department of Urology University Hospital Essen Essen Germany. 

 

B.H., J.G., and C.K. contributed equally to this work.

 

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Abstract

Objectives

To analyse the detection rates of primary magnetic resonance imaging (MRI)‐fusion transperineal prostate biopsy using combined targeted and systematic core distribution in three tertiary referral centres.

Patients and Methods

In this multicentre, prospective outcome study, 807 consecutive biopsy‐naïve patients underwent MRI‐guided transperineal prostate biopsy, as the first diagnostic intervention, between 10/2012 and 05/2016. MRI was reported following the Prostate Imaging‐Reporting and Data System (PI‐RADS) criteria. In all, 236 patients had 18–24 systematic transperineal biopsies only, and 571 patients underwent additional targeted biopsies either by MRI‐fusion or cognitive targeting if PI‐RADS ≥3 lesions were present. Detection rates for any and Gleason score 7–10 cancer in targeted and overall biopsy were calculated and predictive values were calculated for different PI‐RADS and PSA density (PSAD) groups.

Results

Cancer was detected in 68% of the patients (546/807) and Gleason score 7–10 cancer in 49% (392/807). The negative predictive value of 236 PI‐RADS 1–2 MRI in combination with PSAD of <0.1 ng/mL/mL for Gleason score 7–10 was 0.91 (95% confidence interval ± 0.07, 8% of study population). In 418 patients with PI‐RADS 4–5 lesions using targeted plus systematic biopsies, the cancer detection rate of Gleason score 7–10 was significantly higher at 71% vs 59% and 61% with either approach alone (P < 0.001). For 153 PI‐RADS 3 lesions, the detection rate was 31% with no significant difference to systematic biopsies with 27% (P > 0.05). Limitations include variability of multiparametric MRI (mpMRI) reading and Gleason grading.

Conclusion

MRI‐based transperineal biopsy performed at high‐volume tertiary care centres with a significant experience of prostate mpMRI and image‐guided targeted biopsies yielded high detection rates of Gleason score 7–10 cancer. Prostate biopsies may not be needed for men with low PSAD and an unsuspicious MRI. In patients with high probability lesions, combined targeted and systematic biopsies are recommended.

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Editorial: Systematic transperineal and MRI‐targeted biopsies: the resolution of uncertainty

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The paper published in this issue of the BJUI titled ‘Multicentre evaluation of magnetic resonance imaging supported transperineal biopsy in biopsy‐naïve men with suspicion of prostate cancer’ is timely and helps to resolve some of the uncertainty inherent within the diagnostic pathway 1.

The publication of the PROstate MRI Imaging Study (PROMIS) study, although demonstrating that 25% of patients might avoid prostate biopsy with a normal MRI (Prostate Imaging Reporting and Data System [PI‐RADS] 1–2) and that MRI could identify 90% of patients with high‐risk disease (PI‐RADS 5), did not resolve the issue of what to do with equivocal PI‐RADS 3 scans, uncertainty remained 2. The recent publication of the PRECISION trial (Prostate Evaluation for Clinically Important Disease: Sampling Using Image Guidance or Not?) has only contributed to the uncertainty of systematic TRUS biopsy and has shown that targeted biopsies resolve the issue for <50% of the patients overall and only 12% of those with PI‐RADS 3 lesions had a diagnosis of cancer on targeted biopsy only 3. The study has shown that in the face of an identifiable lesion a MRI‐targeted biopsy is non‐inferior to a blind systematic TRUS biopsy, which was positive in only 28% and implies that a systematic biopsy may be unnecessary, so where does that leave us? The uncertainty within MRI remains at the PI‐RADS 3 level, and particularly with a TRUS biopsy that is not a systematic biopsy of the peripheral zone. The authors of the paper highlighted in this issue of the BJUI 1 help to resolve the issue because they describe a more systematic biopsy.

The transperineal (TP) biopsy approach for systematic and targeted biopsy they use is that which was adopted by the Ginsburg Study Group on Enhanced Prostate Diagnostics 4. It is a systematic biopsy that preferentially targets the peripheral zone in a sectoral fashion. It avoids the oversampling inherent in template‐mapping biopsy and the under‐sampling of the non‐systematic transrectal biopsy. Their paper evaluates the combination of an MRI‐targeted biopsy with a systematic TP biopsy. It confirms, as suggested by the PROMIS study, that patients with PI‐RADS 1 or 2 prostates on MRI with a low PSA density <0.1 ng/mL/mL could safely avoid biopsy, based upon a negative predictive value of 0.91 on systematic biopsy. However, in 418 patients with PI‐RADS 4–5 lesions, it was the combination of a targeted and systematic TP biopsy that achieved an overall cancer detection rate of 71%, but that MRI‐targeted biopsies alone had a detection rate of 59% vs 61% for systematic TP biopsies. In the PI‐RAD 3 equivocal group the combined biopsy identified 30% with Gleason score 7–10, whereas targeted biopsy only was positive in 21% vs 27% with systematic biopsies.

The message is clear.

An appropriate systematic biopsy targeted to the peripheral zone remains an essential component of prostate diagnosis even in the MRI era, as indeed it did before MRI was available. In the pre‐MRI days, about one‐third of patients that had negative TRUS biopsies had cancer on TP biopsies and a third of those thought suitable for AS on TRUS biopsy had more significant disease. I suspect in the modern era that figure remains unchanged for those with PI‐RADS 1, 2 or 3, particularly with a PSA density >0.15 ng/mL/mL. As urologists we have always been criticised for over diagnosing and over treating prostate cancer but I suspect that the more heinous crime is that of under treatment of significant disease, it is the very reason why I started doing TP biopsies, to resolve uncertainty. I consider that MRI, for all its benefits in the diagnostic algorithm, cannot yet resolve that uncertainty.

Probably the only patients that merit a target‐only biopsy are those with the high‐PSA, large‐volume disease, easily visible on MRI and usually palpable. Prostate biopsy can be avoided or at least deferred in the PI‐RADS 1–2 group with low PSA density; the rest should be offered a systematic biopsy along with a targeted biopsy. This may be less important in those proceeding to whole gland treatment or surgical extirpation but remains essential in those considering active surveillance, brachytherapy, or any one of the myriad of unproven focal treatments becoming available. The authors should be congratulated for bringing some certainty to uncertainty.

Rick Popert
Urology Centre, Guy’s Hospital, London, UK

 

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References
  • 1 Hansen NL, Barrett T, Kesch C et al. Multicentre evaluation of magnetic resonance imaging supported transperineal prostate biopsy in biopsy‐naïve men with suspicion of prostate cancer. BJU Int 2018; 122: 40–9

 

  • 2 Ahmed HU, El‐Shater Bosaily A, Brown LC et al. Diagnostic accuracy of multi‐parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017; 389: 815–22

 

 

  • 4 Kuru TH, Wadhwa K, Chang RT et al. Definitions of terms, processes and a minimum dataset for transperineal prostate biopsies: a standardization approach of the Ginsburg Study Group for Enhanced Prostate Diagnostics. BJU Int 2013; 112: 568–77

 

Article of the Week: Comparing LRP and RARP to ORP to treat 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.

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

Laparoscopic and robot‐assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review

 

Dragan Ilic*, Sue M. Evans†, Christie Ann Allan*, Jae Hung Jung‡§¶, Declan Murphy** and Mark Frydenberg††

 

*Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, †Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia, ‡Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea, §Department of Urology, University of Minnesota, Urology Section, Minneapolis VA Health Care System, Minneapolis, MN, USA, **Cancer Surgery, Peter MacCallum Cancer Centre, and ††Department of Surgery, Monash University, Melbourne, Vic., Australia

 

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Abstract

Objective

To determine the effects of laparoscopic radical prostatectomy (LRP), or robot‐assisted radical prostatectomy (RARP) compared with open radical prostatectomy (ORP) in men with localized prostate cancer.

Materials and Methods

We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings, with no restrictions on the language of publication or publication status, up until 9 June 2017. We included all randomized or pseudo‐randomized controlled trials that directly compared LRP and RARP with ORP. Two review authors independently examined full‐text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data and assessed risk of bias. We performed statistical analyses using a random‐effects model and assessed the quality of the evidence according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes were prostate cancer‐specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence‐free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions.

Results

We included two unique studies in a total of 446 randomized participants with clinically localized prostate cancer. All available outcome data were short‐term (up to 3 months). We found no study that addressed the outcome of prostate cancer‐specific survival. Based on one trial, RARP probably results in little to no difference in urinary quality of life (mean difference [MD] −1.30, 95% confidence interval [CI] −4.65 to 2.05; moderate quality of evidence) and sexual quality of life (MD 3.90, 95% CI: −1.84 to 9.64; moderate quality of evidence). No study addressed the outcomes of biochemical recurrence‐free survival or overall survival. Based on one trial, RARP may result in little to no difference in overall surgical complications (risk ratio [RR] 0.41, 95% CI: 0.16−1.04; low quality of evidence) or serious postoperative complications (RR 0.16, 95% CI: 0.02–1.32; low quality of evidence). Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at 1 day (MD −1.05, 95% CI: −1.42 to −0.68; low quality of evidence) and up to 1 week (MD −0.78, 95% CI: −1.40 to −0.17; low quality of evidence). Based on one study, RARP probably results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI: −0.32 to 0.34; moderate quality of evidence). Based on one study, RARP probably reduces the length of hospital stay (MD −1.72, 95% CI: −2.19 to −1.25; moderate quality of evidence). Based on two studies, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI: 0.12–0.46; low quality of evidence). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1,000 men (95% CI: 78–48 fewer).

Conclusions

There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes. Urinary and sexual quality of life appear similar. Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions.

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Editorial: RARP and a Parachute

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Radical prostatectomy is probably the most scrutinized, debated and re‐invented procedure in the field of urology. This is with good reason. Dr Hugh Hampton Young gave the first formal account of a radical treatment for prostate cancer in 1905. It was a procedure performed perineally with the prime intention of total cancer extirpation. The oncological results were tremendous given the nascency of the procedure. Functional outcomes, however, were less so, with only ~25% of the patients achieving urinary continence and almost none achieving potency 1. Seminal studies undertaken by Drs Patrick C. Walsh and Pieter J. Donker in the 1980s led to the next major advance in technique: nerve‐sparing. It lead to dramatic improvements in sexual and urinary function preservation, with urinary continence achieved in upwards of 90% and potency in upwards of 60% of patients 2, 3. Nerve‐sparing retropubic radical prostatectomy was rapidly adopted by urologists across the world. No randomized trial was conducted as the operation ‘made sense’, and it would have been unethical to offer patients an alternative, inferior operation. Retropubic radical prostatectomy, however, remained a morbid operation that was difficult to master; 1 200 mL blood loss and 20% incontinence, 15% stricture and 60–90% erectile dysfunction rates were the norm. Robot‐assisted surgery changed much of this. This surgery was perfected and popularized by Dr Mani Menon and his team at the Henry Ford Hospital. Blood loss dropped to ~100 mL, and incontinence and stricture rates today are ~1–5% with potency rates between 70% and 80% 4.

In the systematic review by Ilic et al. 5 trials that compared open with minimally invasive radical prostatectomy were evaluated. The authors are commended for combing through vast quantities of data to arrive at the final sample of two clinical trials (one laparoscopic, one robot‐assisted). The authors found no data on oncological endpoints. With respect to functional outcomes, the data reported in their systematic review are essentially from the recent Yaxley trial. It is true that randomized controlled trials form the backbone of medical progress, but they must be interpreted with care. The Yaxley trial has been criticized for comparing surgeons of vastly varying surgical expertise (1 500‐case experience for open prostatectomies, 200‐case experience for robot‐assisted prostatectomies), having a small sample size (~150 patients in each arm) and having a limited follow‐up (3 months). In line with this, Dr Gordon Smith has eloquently argued about the judicious use of randomized trials in evidence‐based medicine in his classic paper on parachutes and gravitational challenge 6. It is our sincere belief that robot‐assisted radical prostatectomy is a procedure in the service of the patients, and we believe that anyone who has performed both an open radical prostatectomy and a robot‐assisted radical prostatectomy would agree. Operating deep in the pelvis and being able to visualize the anatomy up‐close with robotic assistance ‘makes sense’, much like the anatomical radical prostatectomy did in the 1980s 2, 3.

‘If it ain’t broke, don’t fix it’, the old saying goes. In case of radical prostatectomy, the converse has been true, for the most part. The procedure is still not perfect, and nuances need to be worked out. Nonetheless, over the last century, radicalprogress has been made in the surgery for prostate; the two issues that now remain to be solved are: improving potency and improving cost‐effectiveness. With the potential arrival of competing robotic systems and improvements in technology, the costs associated with robotic surgery may become less of an issue in the future. With regard to potency, focal therapies, whether surgical or otherwise, hold promise.

Akshay Sood, Firas Abdollah, and Mani Menon
Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA

 

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References
  • 1 Young HH. The cure of cancer of the prostate by radical perineal prostatectomy (prostato‐seminal Vesiculectomy): History, Literature and Statistics of Young’s Operation1. J Urol 1945; 53: 188–252

 

 

 

  • 4 Menon M, Dalela D, Jamil M et al. Functional recovery, oncologic outcomes and postoperative complications after robot‐assisted radical prostatectomy: an evidence‐based analysis comparing the Retzius sparing and standard approaches. J Urol 2018; 199: 1210–7

 

  • 5 Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robot‐assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review. BJU Int 2018; 121: 845–53

 

  • 6 Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003; 20: 1459–61

 

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