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Video: Penile lengthening and widening without grafting according to a modified ‘sliding’ technique

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Penile lengthening and widening without grafting according to a modified ‘sliding’ technique

Paulo H. Egydio and Franklin E. Kuehhas*

 

Centre for Peyronie’s Disease Reconstruction, Sao Paulo, Brazil, and *London Andrology Institute, Suite 7 Exhibition House, Addison Bridge Place, London, UK

 

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OBJECTIVE

To present the feasibility and safety of penile length and girth restoration based on a modified ‘sliding’ technique for patients with severe erectile dysfunction (ED) and significant penile shortening, with or without Peyronie’s disease (PD).

PATIENTS AND METHODS

Between January 2013 and January 2014, 143 patients underwent our modified ‘sliding’ technique for penile length and girth restoration and concomitant penile prosthesis implantation. It is based on three key elements: (i) the sliding manoeuvre for penile length restoration; (ii) potential complementary longitudinal ventral and/or dorsal tunical incisions for girth restoration; and (iii) closure of the newly created rectangular bow-shaped tunical defects with Buck’s fascia only.

RESULTS

In all, 143 patients underwent the procedure. The causes of penile shortening and narrowing were: PD in 53.8%; severe ED with unsuccessful intracavernosal injection therapy in 21%; post-radical prostatectomy 14.7%; androgen-deprivation therapy, with or without brachytherapy or external radiotherapy, for prostate cancer in 7%; post-penile fracture in 2.1%; post-redo-hypospadias repair in 0.7%; and post-priapism in 0.7%. In patients with ED and PD, the mean (range) deviation of the penile axis was 45 (0‒100)°. The mean (range) subjective penile shortening reported by patients was 3.4 (1‒7) cm and shaft constriction was present in 53.8%. Malleable penile prostheses were used in 133 patients and inflatable penile prostheses were inserted in 10 patients. The median (range) follow-up was 9.7 (6‒18) months. The mean (range) penile length gain was 3.1 (2‒7) cm. No penile prosthesis infection caused device explantation. The average International Index of Erectile Function (IIEF) score increased from 24 points at baseline to 60 points at the 6-month follow-up.

CONCLUSION

Penile length and girth restoration based on our modified sliding technique is a safe and effective procedure. The elimination of grafting saves operative time and, consequently, decreases the infection risk and costs associated with surgery.

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Article of the Week: Comparison of systematic transrectal biopsy to transperineal MRI/(US)-fusion biopsy for the diagnosis 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.

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. Angelika Borkowetz, discussing her paper. 

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

Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer

Angelika Borkowetz, Ivan Platzek*, Marieta Toma†, Michael Laniado*, Gustavo Baretton†, Michael Froehner, Rainer Koch‡, Manfred Wirth and Stefan Zastrow

 

Department of Urology, *Department of Radiology and Interventional Radiology, †Department of Pathology, and ‡Institution of Medical Statistics and Epidemiology, Technische Universitat, Dresden, Germany

 

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OBJECTIVES

To compare targeted, transperineal magnetic resonance imaging (MRI)/ultrasound (US)-fusion biopsy to systematic transrectal biopsy in patients with previous negative or first prostate biopsy and to evaluate the gain in diagnostic information with systematic biopsies in addition to targeted MRI/US-fusion biopsies.

PATIENTS AND METHODS

In all, 263 consecutive patients with suspicion of prostate cancer were investigated. All patients were evaluated by 3-T multiparametric MRI (mpMRI) applying the European Society of Urogenital Radiology criteria. All patients underwent MRI/US-fusion biopsy transperineally (mean nine cores) and additionally a systematic transrectal biopsy (mean 12 cores).

RESULTS

In all, 195 patients underwent repeat biopsy and 68 patients underwent first biopsy. The median age was 66 years, median PSA level was 8.3 ng/mL and median prostate volume was 50 mL. Overall, the prostate cancer detection rate was 52% (137/263). MRI/US-fusion biopsy detected significantly more cancer than systematic prostate biopsy (44% [116/263] vs 35% [91/263]; P = 0.002). In repeat biopsy, the detection rate was 44% (85/195) in targeted and 32% (62/195) in systematic biopsy (P = 0.002). In first biopsy, the detection rate was 46% (31/68) in targeted and 43% (29/68) in systematic biopsy (P = 0.527). In all, 80% (110/137) of biopsy confirmed prostate cancers were clinically significant. For the upgrading of Gleason score, 44% (32/72) more clinically significant prostate cancer was detected by using additional targeted biopsy than by systematic biopsy alone. Conversely, 12% (10/94) more clinically significant cancer was found by systematic biopsy additionally to targeted biopsy.

CONCLUSIONS

MRI/US-fusion biopsy was associated with a higher detection rate of clinically significant prostate cancer while taking fewer cores, especially in patients with prior negative biopsy. Due to a high portion of additional tumours with Gleason score ≥7 detected in addition to targeted biopsy, systematic biopsy should still be performed additionally to targeted biopsy.

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Editorial: Are men who are biopsied without prior prostate magnetic resonance imaging getting substandard care?

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The article by Borkowetz et al. [1], published in this issue, by a multi-disciplinary group from Dresden who have been offering MRI to their patients since 2012, would suggest so. In their hands, an image-guided biopsy resulted in 29 patients with Gleason scores of 7 or 8 being identified, who had been overlooked by an optimised 12-core systematic biopsy taken at the same sitting. Dedicating a minimum of two cores to a ‘target’ conferred an increase in detection of clinically significant prostate cancer, as defined by Gleason pattern ≥4, of 43% compared with systematic biopsy alone.

There is reason to think that, if anything, this might be an underestimate of the utility of sampling a target of high propensity for clinically significant prostate cancer vs a strategy that tries to spread the needle around the posterior limits of the gland. The reason for this is that the operator was aware of the location of the target during the systematic biopsy, as these were done after the targeted biopsy. The resulting incorporation bias should not trouble us too much, as its effect will be to make systematic biopsy ‘better’ and therefore diminish any difference between the two strategies. The fact that the patients had their systematic biopsy under anaesthesia and were in lithotomy (non-standard conditions) might add further to both bias and direction.

This study [1], like many before, incorporates a mixed population that comprises men who were biopsy-naïve (around one-quarter of the population) and those men who had undergone at least one previous biopsy. Again, this probably does not matter for our purposes, as the two groups were identical for overall cancer detection (52%) and very similar in terms of the proportion of patients with Gleason pattern ≥4 (80% for biopsy-naïve men vs 72% for those who had undergone a previous biopsy). The two groups had a similar number of lesions, around two lesions/subject were declared. The two groups did differ in PSA level; men undergoing repeat biopsy had a median PSA level twice that of men having a biopsy for the first time (12.2 vs 6.1 μg/L).

These results appear to be consistent with those summarised in a recent systematic review of studies that compared a targeted sampling strategy with another [2], but they do differ substantially from a recent study of >1000 biopsy-naïve men who were randomised to MRI vs a standard systematic TRUS biopsy approach [3]. In this large randomised controlled trial from Rome, the overall detection rate in MRI-positive individuals who underwent targeted sampling was 93% (410/440) vs the 52% (137/263) achieved in this study [1].

Both studies show higher detection rates compared with a standard systematic approach, and both show that targeting increases the proportion of men with clinically significant disease. However, exploring the differences between the studies might provide us with insight on how best to refine this new intervention. At present, the detection rate of clinically significant cancer (the generally agreed desired outcome of a biopsy when clinically significant disease is indeed present) is contingent on several variables [4]. They comprise the following: the population sampled; the target condition employed (definition of clinical significance); quality of the imaging; quality of the reporting; the threshold used for declaring a ‘lesion’ a target; the accuracy of the needle placement; the number of cores deployed to the target; and the efficiency of tissue capture. All these differed between the two studies, either explicitly or implicitly.

However, it is likely that the one with the greatest influence on the outcome is the level of certainty attributed to the lesion by the radiologist. There are several scales currently in use and this study used the Prostate Imaging Reporting and Data System (PI-RADS), which comprises an ordinal scale, range 1–5, derived from conditions being either met or unmet [5]. Ideally, a risk stratification system should influence clinical practice. A PI-RADS score of 1–2 should result in avoidance of a biopsy, because of the low probability of finding clinically significant disease. A PI-RADS score of 4–5 should result in a targeted biopsy, because of the high probability of underlying clinically significant disease. A PI-RADS 3 score should prompt a repeat assessment after a given interval, reflecting the indeterminate nature of the prediction.

In the study by Borkowetz et al. [1], PI-RADS scores of 2 and 3 were both associated with a 10% rate of Gleason pattern ≥4, suggesting poor discriminant ability between the two. On the other hand, PI-RADS scores of 4 and 5 were associated with a 24% and 60% detection rate, respectively, of Gleason pattern ≥4. From this we can say that lesions with PI-RADS scores of 4–5 should be targeted, are positively associated with risk, and will confer a high targeting yield. I think we can also say that more work is needed in relation to the inputs that generate PI-RADS 2–3 scores. This, fortunately, is in hand, as a new version of PI-RADS is soon to replace the one used in this article. Hopefully, it will improve the discriminant quality at the lower limits of PI-RADS and, as a result, should allow us to avoid incorporating a PI-RADS score of 2 into our targeting schedule.

Despite issues with the finessing of PI-RADS and other scoring systems, a task that will never be fully complete, this study adds to the burden of proof. What we can say, quite emphatically (based on this study, the systematic review and other studies published since), is that if patients want to maximise the chances of finding clinically significant prostate cancer, if it is indeed present, they should insist on an MRI before biopsy, so that targeting can be incorporated into the sampling strategy. To do otherwise would, according to this study, just about halve the chances of detecting clinically significant prostate cancer, if it were present.

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Mark Emberton
UCL Division of Surgery and Interventional Science, UCL, London, UK

 

References

 

1 Borkowetz A, Platzek I, Toma M et al. Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer. BJU Int 2015; 116: 873–9

 

2 Moore CM, Robertson NL, Arsanious N et al. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol 2013; 63: 125–40.

 

3 Panebianco V, Barchetti F, Sciarra A et al. Multiparametric magnetic resonance imaging vs standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol 2015; 33: 17.e1–7.

 

4 Moore CM, Kasivisvanathan V, Eggener S et al. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an international working group. Eur Urol 2013; 64: 544–52.

 

5 VacheT, Bratan F, Mege-Lechevallier F, Roche S, Rabilloud M, Rouviere O. Characterization of prostate lesions as benign or malignant at multiparametric MR imaging: comparison of three scoring systems in patients treated with radical prostatectomy. Radiology 2014; 272: 446–55.

 

 

Video: Comparison of systematic transrectal biopsy to transperineal MRI/(US)-fusion biopsy for the diagnosis of prostate cancer

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Comparison of systematic transrectal biopsy to transperineal MRI/ultrasound-fusion biopsy for the diagnosis of prostate cancer

Angelika Borkowetz, Ivan Platzek*, Marieta Toma†, Michael Laniado*, Gustavo Baretton†, Michael Froehner, Rainer Koch‡, Manfred Wirth and Stefan Zastrow

 

Department of Urology, *Department of Radiology and Interventional Radiology, †Department of Pathology, and ‡Institution of Medical Statistics and Epidemiology, Technische Universitat, Dresden, Germany

 

Read the full article
OBJECTIVES

To compare targeted, transperineal magnetic resonance imaging (MRI)/ultrasound (US)-fusion biopsy to systematic transrectal biopsy in patients with previous negative or first prostate biopsy and to evaluate the gain in diagnostic information with systematic biopsies in addition to targeted MRI/US-fusion biopsies.

PATIENTS AND METHODS

In all, 263 consecutive patients with suspicion of prostate cancer were investigated. All patients were evaluated by 3-T multiparametric MRI (mpMRI) applying the European Society of Urogenital Radiology criteria. All patients underwent MRI/US-fusion biopsy transperineally (mean nine cores) and additionally a systematic transrectal biopsy (mean 12 cores).

RESULTS

In all, 195 patients underwent repeat biopsy and 68 patients underwent first biopsy. The median age was 66 years, median PSA level was 8.3 ng/mL and median prostate volume was 50 mL. Overall, the prostate cancer detection rate was 52% (137/263). MRI/US-fusion biopsy detected significantly more cancer than systematic prostate biopsy (44% [116/263] vs 35% [91/263]; P = 0.002). In repeat biopsy, the detection rate was 44% (85/195) in targeted and 32% (62/195) in systematic biopsy (P = 0.002). In first biopsy, the detection rate was 46% (31/68) in targeted and 43% (29/68) in systematic biopsy (P = 0.527). In all, 80% (110/137) of biopsy confirmed prostate cancers were clinically significant. For the upgrading of Gleason score, 44% (32/72) more clinically significant prostate cancer was detected by using additional targeted biopsy than by systematic biopsy alone. Conversely, 12% (10/94) more clinically significant cancer was found by systematic biopsy additionally to targeted biopsy.

CONCLUSIONS

MRI/US-fusion biopsy was associated with a higher detection rate of clinically significant prostate cancer while taking fewer cores, especially in patients with prior negative biopsy. Due to a high portion of additional tumours with Gleason score ≥7 detected in addition to targeted biopsy, systematic biopsy should still be performed additionally to targeted biopsy.

Read more articles of the week

Article of the Month: Cabazitaxel Improves QoL in mCRPC

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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.

Final Quality of Life and Safety Data for patients with mCRPC treated with Cabazitaxel in the UK Early Access Programme (NCT01254279)

Amit Bahl*, Susan Masson*, Zafar Malik†, Alison J. Birtle‡, Santhanam Sundar§, Rob J. Jones¶, Nicholas D. James**, Malcolm D. Mason††, Satish Kumar††, David Bottomley‡‡, Anna Lydon§§, Simon Chowdhury¶¶, James Wylie*** and Johann S. de Bono†††

 

*Bristol Haematology and Oncology Centre, Bristol, †Clatterbridge Centre for Oncology, Wirral, ‡Rosemere Cancer Centre, Royal Preston Hospital, Preston, §Nottingham University Hospitals NHS Trust, Nottingham, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, **School of Cancer Sciences, University of Birmingham, Birmingham, ††Velindre Hospital, Cardiff, ‡‡St James’s University Hospital, Leeds, §§South Devon Healthcare NHS Foundation Trust, Torquay, ¶¶Guy’s and St. Thomas’ NHS Foundation Trust, London, ***The Christie NHS Foundationm Trust, Manchester, and †††The Institute for Cancer Research and Royal Marsden Hospital, Sutton, UK

 

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OBJECTIVE

To compile the safety profile and quality of life (QoL) data for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel in the UK Early Access Programme (UK EAP).

PATIENTS AND METHODS

A total of 112 patients participated at 12 UK cancer centres. All had mCRPC with disease progression during or after docetaxel. Patients received cabazitaxel 25 mg/m2 every 3 weeks with prednisolone 10 mg daily for up to 10 cycles. Safety assessments were performed before each cycle and QoL was recorded at alternate cycles using the EQ-5D-3L questionnaire and visual analogue scale (VAS). Thesafety profile was compiled after completion of the UK EAP and QoL measures were analysed to record trends. No formal statistical analysis was carried out.

RESULTS

The incidences of neutropenic sepsis (6.3%), grade 3 and 4 diarrhoea (4.5%) and grade 3 and 4 cardiac toxicity (0%) were low. Neutropenic sepsis episodes, though low, occurred only in patients who did not receive prophylactic granulocyte-colony stimulating factor. There were trends towards improved VAS and EQ-5D-3L pain scores during treatment.

CONCLUSIONS

The UK EAP experience indicates that cabazitaxel might improve QoL in mCRPC and represents an advance and a useful addition to the armamentarium of treatment for patients whose disease has progressed during or after docetaxel. In view of the potential toxicity, careful patient selection is important.

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Editorial: Cabazitaxel for the therapy of mCRPC in the aftermath of CHAARTED

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In this issue of BJUI, Bahl et al. [1] describe clinical outcomes amongst 112 patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel 25 mg/m2 in the UK Early Access Programme (EAP). Patients also received daily oral corticosteroids in a fashion consistent with the phase III TROPIC study and had experienced disease progression during or after docetaxel [2]. The study suggests that improved quality of life and only modest toxicity are achieved with cabazitaxel. Moving forward, the key challenge will be translating these data to clinical practice in the context of a rapidly changing therapeutic landscape.

A veritable game of leapfrog has been ongoing in metastatic prostate cancer. In 2010, two agents were approved by the US Food and Drug Administration, sipuleucel-T and cabazitaxel. Sipuleucel-T, a dendritic cell vaccine, remains largely applied in the pre-docetaxel setting in patients who are either asymptomatic or minimally symptomatic. By contrast, the phase III TROPIC trial leading to the approval of cabazitaxel exclusively included patients who had previously received docetaxel. These approvals made for a relatively straightforward approach to mCRPC, with docetaxel therapy flanked by sipuleucel-T and cabazitaxel. Within 2 years, two novel endocrine therapies emerged, abiraterone and enzalutamide, initially approved in the post-docetaxel space and subsequently in the pre-docetaxel space. A fifth agent, radium-223, was approved for mCPRC in 2013 based on a trial conducted in symptomatic patients with bone metastases who were either post-docetaxel or unfit for or refused docetaxel.

Although editorials and position papers abound, there is actually little consensus regarding the sequencing of these agents. Furthermore, the classification of these therapies as pre- or post-docetaxel may be rendered obsolete in the aftermath of the recently reported CHAARTED trial [3]. In that study, a total of 790 patients with mostly extensive (defined as presence of visceral disease or ≥4 bone lesions with ≥1 lesion beyond the spine or pelvis) newly diagnosed metastatic castration-sensitive prostate cancer were randomized to receive either androgen deprivation therapy (ADT) alone or ADT with six cycles of docetaxel (without daily corticosteroids). The study was closed after a planned interim analysis showed a significant survival advantage in the experimental arm; median overall survival was 57.6 months with docetaxel with ADT vs 44.0 months with ADT alone (hazard ratio 0.49, 95% CI 0.37–0.65; P < 0.001). Furthermore, recent data from the phase III STAMPEDE trial corroborate the robust increment provided by combining docetaxel with ADT in patients with metastatic or high-risk non-metastatic castration-sensitive disease [4]. Thus, for many patients, docetaxel may leap to the fore.

If this is the case, where will cabazitaxel be applied? In patients with mCRPC who have received docetaxel in the castration-sensitive setting, either reinstitution of docetaxel or one of the new agents approved since 2010 may be appropriate. The report by Bahl et al. provides useful data to suggest that cabazitaxel would be reasonably tolerated in this setting, and reports quality-of-life benefits in conjunction with a low incidence of neuropathy and no toxic deaths. Conversely, despite the fact that 79.5% of patients received prophylactic G-CSF from cycle 1 and an additional 5.3% received G-CSF with subsequent cycles, 6.3% experienced neutropenic sepsis, which attests to the substantial myelosuppression caused by this agent. The optimum sequencing of all of the available agents for mCRPC is unclear and there is an absence of validated predictive biomarkers to deploy personalized therapy. Hence, eligibility criteria employed in the landmark trials, and clinical factors such as Gleason score and duration of prior ADT and comorbidities have been used to select agents, although these strategies remain unvalidated. There are published retrospective clinical experiences that address sequencing, which are not definitive. Since the advent of abiraterone and enzalutamide, the use of cabazitaxel has declined. Intriguingly, some but not all retrospective studies suggest that cabazitaxel followed by androgen axis inhibitors might lead to improved outcomes compared with androgen axis inhibitors followed by cabazitaxel [5, 6]. Another piece in the puzzle is provided by retrospective studies suggesting that cabazitaxel may retain substantial activity even after docetaxel and novel androgen inhibitors, while docetaxel appears to show poorer activity after androgen inhibitors [7].

In summary, the EAP data from Bahl et al. [1] characterizes the activity and safety of cabazitaxel in a real-world population. Furthermore, the use of prophylactic G-CSF in accordance with guidelines appeared to eliminate the deaths from neutropenic sepsis observed in the TROPIC trial, which did not use routine prophylactic G-CSF. The ongoing three-arm phase III FIRSTANA trial compares cabazitaxel with docetaxel as first-line chemotherapy for mCRPC and also attempts to refine dosing by investigating both the 25 and 20 mg/m2 doses. Similarly, the PROSELICA phase III trial attempts to show the non-inferiority of the 20 mg/m2 dose of cabazitaxel compared with the 25 mg/m2 dose in the post-docetaxel setting. Randomized phase II trials are investigating the impact of early switching of the taxane (docetaxel or cabazitaxel) in the absence of PSA decline ≥30% within 3 months and the impact of switching to cabazitaxel vs a different androgen inhibitor in those progressing on a first-line androgen inhibitor within 6 months.

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Sumanta K. Pal, Associate Professor and Guru Sonpavde, *Associate Professor

 

Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, and *Department of Medicine, Hematology- Oncology division, University of Alabama School of Medicine, Birmingham, AB, USA

 

References

 

1 Bahl A, Masson S, Malik Z et al. Final quality of life and safety data for patients with mCRPC treated with cabazitaxel in the UK early access programme (NCT01254279). BJU Int 2015; 116: 880–7

 

2 de Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010; 376: 1147–54

 

3 Sweeney CJ, Chen YH , Carducci M et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. New Engl Med 2015; 20: 737–46

 

4 James ND, Snyder M, Mason MD et al. Docetaxel and/or zoledronic acid for hormone-naïve prostate cancer: first overall survival results from STAMPEDE (NCT 00268476). J Clin Oncol 2015; 33:5s; (suppl Abstr 5001)

 

5 Caffo O, De GiorgiU, Fratino L et al. Clinical outcomes of castration- resistant prostate cancer treatments administered as third or fourth line following failure of docetaxel and other second-line treatment: results of an Italian Multicentre Study. Eur Urol 2014; [Epub ahead of print]

 

6 Sonpavde G, Bhor M, Hennessy D et al. Sequencing of Cabazitaxel and Abiraterone Acetate After Docetaxel in Metastatic Castration-Resistant Prostate Cancer: Treatment Patterns and Clinical Outcomes in Multicenter Community-Based US Oncology Practices. Clinical genitourinary cancer 2015; 13: 309–18

 

7 Pezaro CJ, Omlin AG, Altavilla A et al. Activity of cabazitaxel in castration-resistant prostate cancer progressing after docetaxel and next-generation endocrine agents. Eur Urol 2014; 66: 459–65

 

Article of the Week: Predicting pathological outcomes in patients undergoing RARP for high-risk 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.

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. Firas Abdollah, discussing his paper. 

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

Predicting Pathologic Outcomes in Patients Undergoing Robot-Assisted Radical Prostatectomy for High Risk Prostate Cancer:  A Preoperative Nomogram

Firas Abdollah, Dane E. Klett, Akshay Sood, Jesse D. Sammon, Daniel Pucheril, Deepansh Dalela, Mireya Diaz, James O. Peabody, Quoc-Dien Trinh* and Mani Menon

 

Vattikuti Urology Institute, Center for Outcomes Research Analytics and Evaluation, Henry Ford Health System, Detroit, MI, and *Division of Urologic Surgery/Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

 

Read the full article
OBJECTIVE

To identify which high-risk patients with prostate cancer may harbour favourable pathological outcomes at radical prostatectomy (RP).

PATIENTS AND METHODS

We evaluated 810 patients with high-risk prostate cancer, defined as having one or more of the following: PSA level of >20 ng/mL, Gleason score ≥8, clinical stage ≥T2c. Patients underwent robot-assisted RP (RARP) with pelvic lymph node dissection, between 2003 and 2012, in one centre. Only 1.6% (13/810) of patients received any adjuvant treatment. Favourable pathological outcome was defined as specimen-confined disease (SCD; pT2–T3a, node negative, and negative surgical margins) at RARP-specimen. Logistic regression models were used to test the relationship among all available predicators and harbouring SCD. A logistic regression coefficient-based nomogram was constructed and internally validated using 200 bootstrap resamples. Kaplan–Meier method estimated biochemical recurrence (BCR)-free and cancer-specific mortality (CSM)-free survival rates, after stratification according to pathological disease status.

RESULTS

Overall, 55.2% patients harboured SCD at RARP. At multivariable analysis, PSA level, clinical stage, primary/secondary Gleason scores, and maximum percentage tumour quartiles were all independent predictors of SCD (all P < 0.04). A nomogram based on these variables showed 76% discrimination accuracy in predicting SCD, and very favourable calibration characteristics. Patients with SCD had significantly higher 8-year BCR- (72.7% vs 31.7%, P < 0.001) and CSM-free survival rates (100% vs 86.9%, P < 0.001) than patients with non-SCD.

CONCLUSIONS

We developed a novel nomogram predicting SCD at RARP. Patients with SCD achieved favourable long-term BCR- and CSM-free survival rates after RARP. The nomogram may be used to support clinical decision-making, and aid in selection of patients with high-risk prostate cancer most likely to benefit from RARP.

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Editorial: More Nomograms or Better Lymph node dissection – What do we need in Prostate Cancer?

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The publication of nomograms to predict radical prostatectomy (RP) outcome using preoperative parameters were important steps in urological oncology. Abdollah et al. [1], in this issue of BJU International, present a new nomogram to predict specimen-confined disease (SCD; pT2–3a, pN0 R0) in men with high-risk prostate cancer undergoing pelvic lymph node dissection (PLND) and robot-assisted RP (RARP). They used statistical logistic regression to measure the impact of various preoperatively available clinicopathological parameters on the likelihood of pathological outcome and tumour recurrence. The final nomogram accurately identified SCD (pT2–3a, pN0 R0) in 76% of the patients. It is intuitive that these patients have good long-term oncological outcomes after surgery. Consequently, Abdollah et al. found excellent 8-year cancer-specific survival rates in these patients. Because nomograms provide individualised risk prediction for patients in an easily applicable manner, they have become very popular among clinicians. Nomograms are now being applied for almost every aspect of prostate cancer. These are freely available and both patients and physicians are encouraged to use them.

Although nomograms undoubtedly have improved our perspective of disease behaviour and individual patient prediction, several key questions remain. First, how good are the input data to a nomogram? Abdollah et al. [1] evaluated 810 patients with high-risk prostate cancer treated in a single large centre between 2003 and 2012. Impressively, more than half of the patients (55%) harboured SCD at RARP. Such a high chance of having SCD will probably encourage many physicians and patients to choose surgery, even without using a nomogram, because this approach may avoid the need for hormonal treatment, which is obligatory for radiation therapy in high-risk prostate cancer. Second, is the predictive accuracy safe within clinical practice? Most nomograms using clinicopathological data generate predictive accuracies within the range of 75–90% (including the nomogram presented by Abdollah et al. [1]). It is of special importance to consider that 64/447 (14%) of the patients with SCD in the series reported by Abdollah et al. [1] received salvage treatment, which was initiated after a median (interquartile range, IQR) of 4.8 (1.4–9.3) months, and the indication to initiate this salvage therapy was PSA recurrence. Obviously, these patients did not have specimen confined disease and were misclassified. In this case, one might postulate a persistence of nodal disease, given an inadequate extent of PLND. Abdollah et al. [1] reported on a median (IQR) of 5 (3.0–11.0) lymph nodes removed.

In their landmark paper on extended PLND (ePLND) in cadavers, Weingartner et al. [2] demonstrated that a mean lymph node yield of 20 serves as a guideline for sufficient ePLND. More than 10 years ago, Heidenreich et al. [3] reported on a 15% higher rate of lymph node metastasis detection when comparing ePLND with the standard LND (obturator). Bader et al. [4] provided further evidence that an ePLND is needed to provide adequate clinical staging and potential therapeutic benefit. Of 365 patients with clinically localised prostate cancer, 88 (24%) had positive lymph nodes. In this series, a pelvic LND that spared the internal iliac bed would have left 58% of patients with positive nodes with residual disease and 19% would have been incorrectly staged as lymph node-negative for cancer. These data were recently confirmed by several authors when analysing retrospective series. Furthermore, Seiler et al. [5] updated their series of 88 patients and recently reported on the long-term outcome after a median follow-up of 15.6 years. They showed that 18% of those patients with one positive node remained biochemical recurrence free, 28% showed biochemical recurrence only, and 54% had clinical progression. Of these 39 patients, 57% never required deferred androgen-deprivation therapy. In contrast, patients with multiple positive nodes are likely to experience rapid progression and, thus, may benefit from early adjuvant therapies. International clinical practice guidelines recommend the performance of an anatomically ePLND at RP in men with high-risk prostate cancer, for both staging and therapeutic purposes.

Nowadays, most urologists claim to perform an ePLND. However, a recent analysis among 50 671 men who were surgically treated with RP from 2010 to 2011 in the USA showed that, overall, only 69.3% of the high-risk patients underwent concomitant PLND [6]. Surgical approach and hospital characteristics were associated with treatment with PLND and detection of lymph node metastasis. More specifically, patients with prostate cancer undergoing open RP or surgically treated at high-volume centres were more likely to undergo PLND than those undergoing RARP or surgically treated at low-volume centres.

Despite the strong evidence that ePLND positively affects survival in men with limited lymph node involvement, this procedure is not commonly performed. The reasons for this are multiple and include expertise, stage migration and functional and oncological outcomes, as well as economics and the introduction of laparoscopic and laparoscopic RARP. However, this is no reason not to offer the patient, if possible, an operation which has the highest chance of cure

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Martin Spahn
Department of Urology, University Hospital Bern , Inselspital, Bern, Switzerland

 

References

 

1 Abdollah F, Klett DE, Sood A et al. Predicting pathological outcomes in patients undergoing robot-assisted radical prostatectomy for high- risk prostate cancer: a preoperative nomogram. BJU Int 2014; 116: 703–12

 

2 Weingartner K, Ramaswamy A, Bittinger A, Gerharz EW, Voge D, Riedmiller H. Anatomical basis for pelvic lymphadenectomy in prostate cancer: results of an autopsy study and implications for the clinic. J Urol 1996; 156: 1969–71

 

3 Heidenreich A, Varga Z, Von Knobloch R. Extended pelvic lymphadenectomy in patients undergoing radical prostatectomy: high incidence of lymph node metastasis. J Urol 2002; 167: 1681–6

 

4 Bader P, Burkhard FC, Markwalder R, Studer UE. Is a limited lymph node dissection an adequate staging procedure for prostate cancer? J Urol 2002; 168: 514–8

 

5 Seiler R, Studer UE , Tschan K, Bader P, Burkhard FC. Removal of limited nodal disease in patients undergoing radical prostatectomy: long-term results confirm a chance for cure. J Urol 2014; 191: 1280–5

 

6 Wang EH, Yu JB, Gross CP et al. Variation in pelvic lymph node dissection among patients undergoing radical prostatectomy by hospital characteristics and surgical approach: results from the National Cancer Database. J Urol 2015; 193: 820–5.

 

Video: Predicting pathological outcomes in patients undergoing RARP for high-risk prostate cancer: A Preoperative Nomogram

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Predicting Pathologic Outcomes in Patients Undergoing Robot-Assisted Radical Prostatectomy for High Risk Prostate Cancer:  A Preoperative Nomogram

Firas Abdollah, Dane E. Klett, Akshay Sood, Jesse D. Sammon, Daniel Pucheril, Deepansh Dalela, Mireya Diaz, James O. Peabody, Quoc-Dien Trinh* and Mani Menon

 

Vattikuti Urology Institute, Center for Outcomes Research Analytics and Evaluation, Henry Ford Health System, Detroit, MI, and *Division of Urologic Surgery/Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

 

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OBJECTIVE

To identify which high-risk patients with prostate cancer may harbour favourable pathological outcomes at radical prostatectomy (RP).

PATIENTS AND METHODS

We evaluated 810 patients with high-risk prostate cancer, defined as having one or more of the following: PSA level of >20 ng/mL, Gleason score ≥8, clinical stage ≥T2c. Patients underwent robot-assisted RP (RARP) with pelvic lymph node dissection, between 2003 and 2012, in one centre. Only 1.6% (13/810) of patients received any adjuvant treatment. Favourable pathological outcome was defined as specimen-confined disease (SCD; pT2–T3a, node negative, and negative surgical margins) at RARP-specimen. Logistic regression models were used to test the relationship among all available predicators and harbouring SCD. A logistic regression coefficient-based nomogram was constructed and internally validated using 200 bootstrap resamples. Kaplan–Meier method estimated biochemical recurrence (BCR)-free and cancer-specific mortality (CSM)-free survival rates, after stratification according to pathological disease status.

RESULTS

Overall, 55.2% patients harboured SCD at RARP. At multivariable analysis, PSA level, clinical stage, primary/secondary Gleason scores, and maximum percentage tumour quartiles were all independent predictors of SCD (all P < 0.04). A nomogram based on these variables showed 76% discrimination accuracy in predicting SCD, and very favourable calibration characteristics. Patients with SCD had significantly higher 8-year BCR- (72.7% vs 31.7%, P < 0.001) and CSM-free survival rates (100% vs 86.9%, P < 0.001) than patients with non-SCD.

CONCLUSIONS

We developed a novel nomogram predicting SCD at RARP. Patients with SCD achieved favourable long-term BCR- and CSM-free survival rates after RARP. The nomogram may be used to support clinical decision-making, and aid in selection of patients with high-risk prostate cancer most likely to benefit from RARP.

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Article of the Week: Does timing matter in postoperative RT for patients at high-risk of recurrence after RP?

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

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

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. Peter Carroll, discussing his paper. 

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

Postoperative radiation therapy for patients at high-risk of recurrence after radical prostatectomy: does timing matter?

Charles C. Hsu*†, Alan T. Paciorek‡, Matthew R. Cooperberg‡, Mack Roach III*, I-Chow J. Hsu* and Peter R. Carroll‡

 

*Department of Radiation Oncology, Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, †Department of Radiation Oncology, College of Medicine, University of Arizona, Tucson, AZ, and ‡Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA

 

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OBJECTIVE

To evaluate among radical prostatectomy (RP) patients at high-risk of recurrence whether the timing of postoperative radiation therapy (RT) (adjuvant, early salvage with detectable post-RP prostate-specific antigen [PSA], or ‘late’ salvage with a PSA level of >1.0 ng/mL) is significantly associated with overall survival (OS), prostate-cancer specific survival or metastasis-free survival, in a longitudinal cohort.

PATIENTS AND METHODS

Of 6 176 RP patients in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), 305 patients with high-risk pathological features (margin positivity, Gleason score 8–10, or pT3–4) who underwent postoperative RT were examined, either in the adjuvant (≤6 months after RP with undetectable PSA levels, 76 patients) or salvage setting (>6 months after RP or pre-RT PSA level of >0.1 ng/mL, 229 patients). Early (PSA level of ≤1.0 ng/mL, 180 patients) or late salvage RT (PSA level >1.0 ng/mL, 49 patients) was based on post-RP, pre-RT PSA level. Multivariable Cox regression examined associations with all-cause mortality and prostate cancer-specific mortality and/or metastases (PCSMM).

RESULTS

After a median of 74 months after RP, 65 men had died (with 37 events of PCSMM). Adjuvant and salvage RT patients had comparable high-risk features. Compared with adjuvant, salvage RT (early or late) had an increased association with all-cause mortality (hazard ratio [HR] 2.7, P = 0.018) and with PCSMM (HR 4.0, P = 0.015). PCSMM-free survival differed by further stratification of timing, with 10-year estimates of 88%, 84%, and 71% for adjuvant, early salvage, and late salvage RT, respectively (P = 0.026). For PCSMM-free survival and OS, compared with adjuvant RT, late salvage RT had statistically significantly increased risk; however, early salvage RT did not.

CONCLUSION

This analysis suggests that patients who underwent early salvage RT with PSA levels of <1.0 ng/mL may have comparable metastasis-free survival and OS compared with adjuvant RT; however, late salvage RT with a PSA level of >1.0 ng/mL is associated with worse clinical outcomes.

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