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Article of the Week: Minimum five-year follow-up of 1,138 consecutive laparoscopic radical prostatectomies

Every week the Editor-in-Chief selects the 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 Ricardo Soares, discussing his paper. 

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

Minimum five-year follow-up of 1,138 consecutive laparoscopic radical prostatectomies

Ricardo Soares, Antonina Di Benedetto, Zach Dovey, Simon Bott*, Roy G. McGregor† and Christopher G. Eden

 

Department of Urology, Royal Surrey County Hospital, Guildford, *Department of Urology, Frimley Park Hospital, Frimley, Surrey, UK, and Cornwall Regional Hospital, Montego Bay, Jamaica

 

OBJECTIVES

To investigate the long-term outcomes of laparoscopic radical prostatectomy (LRP).

PATIENTS AND METHODS

In all, 1138 patients underwent LRP during a 163-month period from 2000 to 2008, of which 51.5%, 30.3% and 18.2% were categorised into D’Amico risk groups of low-, intermediate- and high-risk, respectively. All intermediate- and high-risk patients were staged by preoperative magnetic resonance imaging or computed tomography and isotope bone scanning, and had a pelvic lymph node dissection (PLND), which was extended after April 2008. The median (range) patient age was 62 (40–78) years; body mass index was 26 (19–44) kg/m2; prostate-specific antigen level was 7.0 (1–50) ng/mL and Gleason score was 6 (6–10). Neurovascular bundle was preservation carried out in 55.3% (bilateral 45.5%; unilateral 9.8%) of patients.

RESULTS

The median (range) gland weight was 52 (14–214) g. The median (range) operating time was 177 (78–600) min and PLND was performed in 299 patients (26.3%), of which 54 (18.0%) were extended. The median (range) blood loss was 200 (10–1300) mL, postoperative hospital stay was 3 (2–14) nights and catheterisation time was 14 (1–35) days. The complication rate was 5.2%. The median (range) LN count was 12 (4–26), LN positivity was 0.8% and the median (range) LN involvement was 2 (1–2). There was margin positivity in 13.9% of patients and up-grading in 29.3% and down-grading in 5.3%. While 11.4% of patients had up-staging from T1/2 to T3 and 37.1% had down-staging from T3 to T2. One case (0.09%) was converted to open surgery and six patients were transfused (0.5%). At a mean (range) follow-up of 88.6 (60–120) months, 85.4% of patients were free of biochemical recurrence, 93.8% were continent and 76.6% of previously potent non-diabetic men aged <70 years were potent after bilateral nerve preservation.

CONCLUSIONS

The long-term results obtainable from LRP match or exceed those previously published in large contemporary open and robot-assisted surgical series.

Editorial: The need for standardised reporting of complications

In the context of diversifying practice models, implementation of new technologies such as the Da Vinci surgical robot and rising healthcare costs, there is growing interest in evaluating the quality of surgical work. This extends into health policy, as reimbursement penalties are introduced for ‘inappropriate’ outcomes (e.g. excessive readmissions). Consequently, there is a significant need to provide an accurate assessment of complications and mortality when reporting on surgical outcomes.

Despite the constant use of outcomes data to measure effectiveness in surgery, no current urology guidelines demand the standardised reporting of surgical complications [1]. As randomised controlled trials are uncommon within the surgical setting, and are associated with significant biases [2], there is a distinct need for a uniform reporting system after urological surgeries. Indeed, the lack of such makes it challenging to compare surgical outcomes between techniques, surgeons and institutions, thus hampering the interpretation of study results [3]. The ongoing (and never-ending) debate on the comparative effectiveness of open vs robot-assisted radical prostatectomy (RP) highlights the need for standardised methods to assess superiority (or inferiority) of surgical results [4].

In this issue of the BJUI, Soares et al. [5] present a single-surgeon study of 1138 laparoscopic RPs (LRPs) with a standardised approach between the years 2000 and 2008, and their 5-year follow-up. Whereas the functional and/or oncological equivalency of LRP compared with open RP has been reported before [6], perhaps the outstanding contribution of this study is the use of the Martin-Donat criteria to report and analyse surgical results [3, 7]. In 2002, Martin et al. [7] introduced a list of 10 standard criteria for accurate and comprehensive reporting of surgical complications (e.g. methods of data acquisition, duration of follow-up, definition of complications, hospital length of stay).

In Table 6 of their manuscript, Soares et al. [5] display surgical and/or oncological outcomes of a total of 17 studies on LRP (including their own data). This table suggests the obvious: there is no consistency of reporting on outcomes. In the 2007 Donat [3] analysis of surgical complications reporting in the urological literature, only 2% of a total of 109 studies met nine to 10 of the critical Martin criteria. Interestingly, these shortcomings have been addressed in more contemporary years as the number of studies complying with most of the Martin criteria has increased between 1999/2000 and 2009/2010 [1]. Yet, despite the increasing use of classification systems for outcomes of surgery and standardised reporting of complications (e.g. Clavien-Dindo classification), they are not routinely applied [1, 8].

In an era where the adoption of a certain surgical approach or technique needs to be carefully weighted against a demand for greater value and decreased costs, a simple case series on positive outcomes is simply not sufficient [9]; at the very least, guideline-compliant assessment of outcomes should be the standard of care.

 

Marianne Schmid*, Christian P. Meyer*† and Quoc-Dien Trinh*

 

*Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Womens Hospital, Harvard Medical School, Boston, MA, USA and† Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

 

References

1 Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss MReporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol 2012; 61: 3419

 

 

 

4 Schmid M, Gandaglia G, Trinh QD. The controversy that will not go away. Eur Urol 2014; [Epub ahead of print]. doi: 10.1016/ j.eururo.2014.02.052

 

5 Soares R, Di Benedetto A, Dovey Z, Bott S, McGregor R, Eden CMinimum 5-year follow-up of 1138 consecutive laparoscopic radical prostatectomies. BJU Int 2014; [Epub ahead of print]. doi: 10.1111/ bju.12887

 

6 Hruza M, Bermejo JL, Flinspach B et al. Long-term oncological outcomes after laparoscopic radical prostatectomy. BJU Int 2013; 111:  27180

 

7 Martin RC 2nd, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg 2002; 235: 80313

 

 

9 Novara G, Ficarra V, DElia C, Secco S, Cavalleri S, Artibani W. Trifecta outcomes after robot-assisted laparoscopic radical prostatectomy. BJU Int 2011; 107: 1004

 

Video: 1,138 consecutive laparoscopic radical prostatectomies – Minimum five-year follow-up

Minimum five-year follow-up of 1,138 consecutive laparoscopic radical prostatectomies

Ricardo Soares, Antonina Di Benedetto, Zach Dovey, Simon Bott*, Roy G. McGregor† and Christopher G. Eden

 

Department of Urology, Royal Surrey County Hospital, Guildford, *Department of Urology, Frimley Park Hospital, Frimley, Surrey, UK, and Cornwall Regional Hospital, Montego Bay, Jamaica

 

OBJECTIVES

To investigate the long-term outcomes of laparoscopic radical prostatectomy (LRP).

PATIENTS AND METHODS

In all, 1138 patients underwent LRP during a 163-month period from 2000 to 2008, of which 51.5%, 30.3% and 18.2% were categorised into D’Amico risk groups of low-, intermediate- and high-risk, respectively. All intermediate- and high-risk patients were staged by preoperative magnetic resonance imaging or computed tomography and isotope bone scanning, and had a pelvic lymph node dissection (PLND), which was extended after April 2008. The median (range) patient age was 62 (40–78) years; body mass index was 26 (19–44) kg/m2; prostate-specific antigen level was 7.0 (1–50) ng/mL and Gleason score was 6 (6–10). Neurovascular bundle was preservation carried out in 55.3% (bilateral 45.5%; unilateral 9.8%) of patients.

RESULTS

The median (range) gland weight was 52 (14–214) g. The median (range) operating time was 177 (78–600) min and PLND was performed in 299 patients (26.3%), of which 54 (18.0%) were extended. The median (range) blood loss was 200 (10–1300) mL, postoperative hospital stay was 3 (2–14) nights and catheterisation time was 14 (1–35) days. The complication rate was 5.2%. The median (range) LN count was 12 (4–26), LN positivity was 0.8% and the median (range) LN involvement was 2 (1–2). There was margin positivity in 13.9% of patients and up-grading in 29.3% and down-grading in 5.3%. While 11.4% of patients had up-staging from T1/2 to T3 and 37.1% had down-staging from T3 to T2. One case (0.09%) was converted to open surgery and six patients were transfused (0.5%). At a mean (range) follow-up of 88.6 (60–120) months, 85.4% of patients were free of biochemical recurrence, 93.8% were continent and 76.6% of previously potent non-diabetic men aged <70 years were potent after bilateral nerve preservation.

CONCLUSIONS

The long-term results obtainable from LRP match or exceed those previously published in large contemporary open and robot-assisted surgical series.

What’s the diagnosis?

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Test yourself against our experts with our weekly quiz. You can type your answers here if you want to compare with our answers.

Following on from last week’s image, this is also taken from the same paper by Poulsen et al, BJUI 2014. This is the same patient just undergoing a different scan.

No such quiz/survey/poll

Article of the Month: Indications for Intervention During Active Surveillance of Prostate Cancer

Every week the Editor-in-Chief selects the 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. Max Kates discussing his paper. 

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

Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

 

Editorial: How active should active surveillance be?

 Many investigators, including those from Johns Hopkins University (JHU) and the Prostate cancer Research International: Active Surveillance project (PRIAS), have provided meaningful data to strongly support the increasing use of active surveillance (AS) across the world. There are a multitude of strategies to minimise excessive rates of prostate cancer over detection and overtreatment. After the diagnosis of prostate cancer, the single best is AS for appropriately selected men.

 For decades, the concept of not treating a prostate cancer in otherwise healthy men, even if low-grade and low-volume was typically considered nihilistic and heretical, particularly in the USA. Thankfully, data have largely made this line of thinking anachronistic. The era of sensibly applied AS is upon us, and single-institution series with intermediate-term follow-up are excellent, with exceedingly low rates of metastasis or cancer-related death. However, we await longer-term (>10 years) outcomes from the contemporary PSA screening era.

 The ‘success’ of AS is largely dependent on the entry criteria, follow-up strategies, and indications for curative intervention. Highly restrictive inclusion criteria, rigorous biopsy based follow-up and strict definitions of reclassification triggering treatment have produced superb outcomes. Critics appropriately argue these criteria exclude a significant proportion of men with a low rate of requiring treatment or having metastases, if allowed on AS. Conversely, other programmes with looser entry criteria, more lax follow-up, and relaxed indications for intervention will be more inclusive and have lower rates of immediate or delayed intervention but must be counterbalanced against the expected higher rate of metastases or death.

 The current study [1] evaluates two different AS follow-up strategies from JHU and PRIAS. In general, JHU uses annual biopsies with progression defined as a new PSA density >0.15 ng/mL/mL or increasing tumour volume or grade beyond a certain threshold, while PRIAS recommends less frequent biopsies (years 1, 4, and 7) while relying on serological (PSA doubling time, PSADT) alongside histological indicators for defining progression and recommending treatment.

 Not surprisingly, different strategies lead to varying expected outcomes. Among the JHU patients, 38% were reclassified at a median of 2.1 years. Nearly two-thirds of the reclassified would have been identified at the PRIAS year 1 or triennial biopsies with 16% identified between PRIAS biopsies at a median delay of 1.9 years. The unanswerable but incredibly important question is whether this delay is essentially a non-issue, perhaps a favourable attribute (more AS time without compromising cure rates), or clinically disastrous (patients no longer curable).

 PRIAS relies heavily on PSA kinetics, which can be a double-edged sword. Among men in the JHU programme with >5 years follow-up, 11% would have delayed reclassification compared with PRIAS at a median time of 4.7 years. Additionally, 12% would have undergone intervention due to PRIAS-defined PSADT but not progressed based on the JHU protocol. It is convenient and perhaps intuitive that PSA kinetics should predict progression and meaningful clinical events for men on AS; however, the data from multiple studies have simply not supported this concept [2, 3].

 The JHU programme has restrictive entry rules compared with most other programmes, a rigorous biopsy based follow-up protocol, and strict criteria to treat, which is exactly why no metastasis or death have been reported among 769 men, some with up to 15 years follow-up[4]. Guidelines are needed but should not be overly prescriptive or rigid. For example, a surveillance biopsy showing a single core of Gleason 6 encompassing 60% of the total core or three cores of Gleason 6 with total cancer length of 3 mm would lead to a recommendation of treatment according to published JHU criteria. Many of us would not be phased with these biopsy reports and comfortably recommend ongoing AS.

 Data from AS series are very encouraging but it is highly likely we can do even better. For example, 10-year cancer-specific survival is 97% in the Sunnybrook AS experience and all five cancer-related deaths occurred in patients that would not meet most contemporary AS entry criteria [5, 6]. I am hopeful and confident that emerging data incorporating MRI imaging, serum biomarkers (e.g. prostate health index), or tissue-based biomarkers (e.g. Prolaris, Oncotype Dx) will provide us with a more comprehensive understanding of these men’s cancer such that tailored, evidence-based recommendations can be even more accurate.

 There is much yet to be learned about AS and this study [1] adds to our knowledge. Surveillance for prostate cancer is definitely active, but it is also dynamic and evolving.

Read the full article
Scott Eggener
Associate Professor of Surgery, University of Chicago, Chicago, IL, USA

 

References

 

 

Video: Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

A #RadOnc Movember

The #RadOnc Journal Club continued its success in Movember with over 700 tweets from 60 participants in a three-day discussion on smoking and prostate cancer radiation treatment outcomes. Thanks to the generosity of the BJUI (@BJUIJournal) and Prof. Prokar Dasgupta (@prokarurol), the study of a large retrospective cohort of localized prostate cancer patients who received external beam radiation treatment from Memorial Sloan Kettering (@sloan _kettering) was open-access and engaged a wide audience.

Background discussion started Friday and covered a variety of topics including limiting treatment toxicity:

Sharing best practices on the role of radiation treatment from around the world:

The state of tobacco use:

And smoking cessation from an interdisciplinary audience:

On Sunday, the community came together for a live discussion with study author Emily Steinberger (@easteinberger). Participants explored roles for radiation treatment and the reduction of side effects including hypofractionated treatment and current guidelines for IMRT:


Practice patterns in patient assessment stressed the importance of a tobacco history. These encounters created an opportunity for cessation counselling as opposed to guiding treatment decisions while recognizing the threat of information overload.


The conversation then moved to the study. Results showed current-smokers had a higher PSA relapse rate (HR 1.37 compared to former or non-smokers), more distant metastases (DM-free survival 72% vs. 87% in never-smokers), and higher cancer specific mortality (HR 2.25). There were a few surprises including finding no significant differences based on pack-years smoked and that only current as opposed to former smoking status mattered.

Study strengths included a large cohort of 2358 similarly-treated patients; 91% having documented smoking histories. Limitations included the retrospective design, especially considering the long natural history of prostate cancer and risk of development of confounding comorbidities. Also an important reminder:

Conversations concluded with considerations for future practice:


Research:


With a little #RadOnc humor in-between.

We recognize the quality contributions from all members of our community. For their leadership during this chat, congratulations to Dr. Jay Detsky (@JayDetsky) and Dr. Mohammad Alfayez (@alfayezmo) who received the Jerry Maguire Award for their evidence-based tweets. (“Show me the data!!!”) The Francis Peabody award went to Dr. Jonathan Livergant (@jpil) and Dr. Jarad Martin (@DocJarad) for the best clinical tweets. We will be looking forward to more lively conversations in the New Year!

The #RadOnc Journal Club was first proposed at the Yale Department of Therapeutic Radiology in April 2014 to leverage published evidence and stimulate discussion on key topics in radiation oncology. It became part of Radiation Nation – a community founded by Dr. Matthew Katz (@subatomicdoc) dedicated to improve cancer care through online collaborative conversations on education, medical practice, and quality and safety improvement for patients, caregivers, and medical professionals. Interest grew globally and in September, where we bridged cultural divides by encouraging conversations in multiple languages. Today, we routinely have participation from over 5 countries during the #RadOnc Journal Club and on Radiation Nation blog.

Ian Pereira is an R2 resident in Radiation Oncology at Queen’s University, Kingston, Canada. He believes that education is a basis for progress in health and care, and is interested in leveraging new technologies including social media in medical education.

 

Article of the Week: Spine Metastases in Prostate Cancer: Comparison of [99mTc]MDP Wholebody Bone Scintigraphy, [18F]Choline PET/CT, and [18F]NaF PET/CT

Every week the Editor-in-Chief selects the 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.

Spine metastases in prostate cancer: comparison of technetium-99m-MDP whole-body bone scintigraphy, [18F]choline positron emission tomography(PET)/computed tomography (CT) and [18F]NaF PET/CT

Mads H. Poulsen, Henrik Petersen*, Poul F. Høilund-Carlsen*, Jørn S. Jakobsen, Oke Gerke*, Jens Karstoft†, Signe I. Steffansen* and Steen Walter

Research Unit of Urology, Department of Urology, and Departments of *Nuclear Medicine and †Radiology, Odense University Hospital, Odense, Denmark

Read the full article
OBJECTIVE

To compare the diagnostic accuracy of the following imaging techniques in the detection of spine metastases, using magnetic resonance imaging (MRI) as a reference: whole-body bone scintigraphy (WBS) with technetium-99m-MDP, [18F]-sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and [18F]-fluoromethylcholine (FCH) PET/CT.

PATIENTS AND METHODS

The study entry criteria were biopsy-proven prostate cancer, a positive WBS consistent with bone metastases, and no history of androgen deprivation. Within 30 days of informed consent, trial scans were performed in random order. Scans were interpreted blindly for the purpose of a lesion-based analysis. The primary target variable was bone lesion (malignant/benign) and the ‘gold standard’ was MRI.

RESULTS

A total of 50 men were recruited between May 2009 and March 2012. Their mean age was 73 years, their median PSA level was 84 ng/mL, and the mean Gleason score of the tumours was 7.7. A total of 46 patients underwent all four scans, while four missed one PET/CT scan. A total of 526 bone lesions were found in the 50 men: 363 malignant and 163 non-malignant according to MRI. Sensitivity, specificity, positive and negative predictive values and accuracy were: WBS: 51, 82, 86, 43 and 61%; NaF-PET/CT: 93, 54, 82, 78 and 81%; and FCH-PET/CT: 85, 91, 95, 75 and 87%, respectively.

CONCLUSIONS

We found that FCH-PET/CT and NaF-PET/CT were superior to WBS with regard to detection of prostate cancer bone metastases within the spine. The present results call into question the use of WBS as the method of choice in patients with hormone-naïve prostate cancer.

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