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Video: Improving Prostate Cancer Risk Assessment Using The PHI

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Improving Multivariable Prostate Cancer Risk Assessment Using The Prostate Health Index

Robert W. Foley*†, Laura Gorman*, Neda Sharifi‡, Keefe Murphy§, Helen Moore‡, Alexandra V. Tuzova**, Antoinette S. Perry**, T. Brendan Murphy§, Dara J. Lundon*††† and R. William G. Watson*†

 

*Conway Institute of Biomolecular and Biomedical Research, University College Dublin, †UCD School of Medicine and Medical Science, University College Dublin, ‡Department of Biochemistry, Beaumont Hospital, §UCD School of Mathematical Sciences, University College Dublin, Insight Centre for Data Analytics, University College Dublin, **Prostate Molecular Oncology, Institute of Molecular Medicine, Trinity College Dublin, and ††Department of Urology, Mater Misericordiae University Hospital, Dublin, Ireland

 

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Objectives

To analyse the clinical utility of a prediction model incorporating both clinical information and a novel biomarker, p2PSA, in order to inform the decision for prostate biopsy in an Irish cohort of men referred for prostate cancer assessment.

Patients and Methods

Serum isolated from 250 men from three tertiary referral centres with pre-biopsy blood draws was analysed for total prostate-specific antigen (PSA), free PSA (fPSA) and p2PSA. From this, the Prostate Health Index (PHI) score was calculated (PHI = (p2PSA/fPSA)*√tPSA). The men’s clinical information was used to derive their risk according to the Prostate Cancer Prevention Trial (PCPT) risk model. Two clinical prediction models were created via multivariable regression consisting of age, family history, abnormality on digital rectal examination, previous negative biopsy and either PSA or PHI score, respectively. Calibration plots, receiver-operating characteristic (ROC) curves and decision curves were generated to assess the performance of the three models.

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Results

The PSA model and PHI model were both well calibrated in this cohort, with the PHI model showing the best correlation between predicted probabilities and actual outcome. The areas under the ROC curve for the PHI model, PSA model and PCPT model were 0.77, 0.71 and 0.69, respectively, for the prediction of prostate cancer (PCa) and 0.79, 0.72 and 0.72, respectively, for the prediction of high grade PCa. Decision-curve analysis showed a superior net benefit of the PHI model over both the PSA model and the PCPT risk model in the diagnosis of PCa and high grade PCa over the entire range of risk probabilities.

Conclusion

A logical and standardized approach to the use of clinical risk factors can allow more accurate risk stratification of men under investigation for PCa. The measurement of p2PSA and the integration of this biomarker into a clinical prediction model can further increase the accuracy of risk stratification, helping to better inform the decision for prostate biopsy in a referral population.

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Video: NSAID use is not associated with erectile dysfunction risk

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Non-steroidal anti-inflammatory drug (NSAID) use is not associated with erectile dysfunction risk: results from the Prostate Cancer Prevention Trial

Darshan P. Patel, Jeannette M. Schenk*, Amy Darke†, Jeremy B. Myers, William O. Brant and James M. Hotaling

 

Division of Urology, University of Utah, Salt Lake City, UT, *Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA, and †SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

 

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Objective

To evaluate the associations of non-steroidal anti-inflammatory drug (NSAID) use with risk of erectile dysfunction (ED), considering the indications for NSAID use.

Patients and Methods

We analysed data from 4 726 men in the placebo arm of the Prostate Cancer Prevention Trial (PCPT) without evidence of ED at baseline. Incident ED was defined as mild/moderate (decrease in normal function) or severe (absence of function). Proportional hazards models were used to estimate the covariate-adjusted associations of NSAID-related medical conditions and time-dependent NSAID use with ED risk.

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Results

Arthritis (hazard ratio [HR] 1.56), chronic musculoskeletal pain (HR 1.35), general musculoskeletal complaints (HR 1.36), headaches (HR 1.44), sciatica (HR 1.50) and atherosclerotic disease (HR 1.60) were all significantly associated with an increased risk of mild/moderate ED, while only general musculoskeletal complaints (HR 1.22), headaches (HR 1.47) and atherosclerotic disease (HR 1.60) were associated with an increased risk of severe ED. Non-aspirin NSAID use was associated with an increased risk of mild/moderate ED (HR 1.16; P = 0.02) and aspirin use was associated with an increased risk of severe ED (HR 1.16; P = 0.03, respectively). The associations of NSAID use with ED risk were attenuated after controlling for indications for NSAID use.

Conclusions

The modest associations of NSAID use with ED risk in the present cohort were probably attributable to confounding indications for NSAID use. NSAID use was not associated with ED risk.

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Step-By-Step: RAPN with intracorporeal renal hypothermia using ice slush

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Robot-assisted partial nephrectomy with intracorporeal renal hypothermia using ice slush: step-by-step technique and matched comparison with warm ischaemia

 

Daniel Ramirez, Peter A. Caputo, Jayram Krishnan, Homayoun Zargar* and Jihad H. Kaouk
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA, and *Royal Melbourne Hospital, Melbourne, Vic, Australia

 

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Objectives

To outline our step-by-step technique for intracorporeal renal cooling during robot-assisted partial nephrectomy (RAPN).

Patients and Methods

Patient selection was performed during a preoperative clinic visit. Cases where we estimated during preoperative assessment that warm ischaemia time would be >30 min, as determined by whether the patient had a complex renal mass, were selected. The special equipment required for this procedure includes an Ecolab Hush Slush machine (Microtek Medical Inc., Columbus, MS, USA) a Mon-a-therm needle thermocouple device (Covidien, Mansfield, MA, USA) and six modified 20-mL syringes. Patients are arranged in a 60° modified flank position with the operating table flexed slightly at the level of the anterior superior iliac spine. For the introduction of a temperature probe and ice slush, an additional 12-mm trocar is placed along the mid-axillary line beneath the costal margin. Modified 10/20 mL syringes are prefilled with ice slush for instillation via an accessory trocar. Peri-operative and 6-month functional outcomes in the cold ischaemia group were compared with those of a cohort of patients who underwent RAPN with warm ischaemia in a 2:1 matched fashion. Matching was performed based on preoperative estimated glomerular filtration rate (GFR), ischaemia time and RENAL nephrometry score.

Results

Strategies for successful intracorporeal renal cooling include: (i) placement of accessory port directly over the kidney; (ii) uniform ice consistency and modified syringes; (iii) sequential clamping of renal artery and vein; (iv) protection of the neighbouring intestine with a laparoscopic sponge; and (v) complete mobilization of the kidney. Kidney temperature is monitored via a needle thermocoupler device, while core body temperature is concurrently monitored via an oesophageal probe in real time. Renal function was assessed by serum creatinine level, estimated GFR (eGFR) and mercaptoacetyltriglycine (MAG-3) renal scan, peri-operatively and at 6-month follow-up. In the separate matched analysis, cold ischaemia during RAPN was found to be associated with a 12.9% improvement in preservation of postoperative eGFR. No difference was seen in either group at 6-month follow-up.

Conclusions

We conclude that RAPN with intracorporeal renal hypothermia using ice slush is technically feasible and may improve postoperative renal function in the short term. Our technique for intracorporeal hypotheramia is cost-effective, simple and highly reproducible.

 

Video: PSMs in RP patients do not predict long-term oncological outcomes

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Positive Surgical Margins in Radical Prostatectomy Patients Do Not Predict Long-term Oncological Outcomes: Results from SEARCH

Prabhakar Mithal, Lauren E. Howard†‡, William J. Aronson§, Martha K. Terris**††, Matthew R. Cooperberg‡‡, Christopher J. Kane§§, Christopher Amling¶¶ and Stephen J. Freedland‡***

 

Department of Urology, University of Rochester Medical Center, Rochester, NY, †Department of Biostatistics and Bioinformatics, Duke University School of Medicine, ‡Division of Urology, Veterans Affairs Medical Center, Durham, NC, §Urology Section, Department of Surgery, Veterans Affairs Greater Los Angeles Healthcare System, Department of Urology, UCLA School of Medicine, Los Angeles, CA, **Section of Urology, Veterans Affairs Medical Center, ††Section of Urology, Medical College of Georgia, Augusta, GA, ‡‡Department of Urology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, §§Urology Department, University of California San Diego Health System, San Diego, CA , ¶¶Division of Urology, Department of Surgery, Oregon Health and Science University, Portland, OR , and ***Division of Urology, Department of Surgery, Cedars Sinai Medical Center, Los Angeles, CA, USA

 

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Objective

To assess the impact of positive surgical margins (PSMs) on long-term outcomes after radical prostatectomy (RP), including metastasis, castrate-resistant prostate cancer (CRPC), and prostate cancer-specific mortality (PCSM).

Patients and Methods

Retrospective study of 4 051 men in the Shared Equal Access Regional Cancer Hospital (SEARCH) cohort treated by RP from 1988 to 2013. Proportional hazard models were used to estimate hazard ratios (HRs) of PSMs in predicting biochemical recurrence (BCR), CRPC, metastases, and PCSM. To determine if PSMs were more predictive in certain patients, analyses were stratified by pathological Gleason score, stage, and preoperative prostate-specific antigen (PSA) level.

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Results

The median (interquartile range) follow-up was 6.6 (3.2–10.6) years and 1 127 patients had >10 years of follow-up. During this time, 302 (32%) men had BCR, 112 (3%) developed CRPC, 144 (4%) developed metastases, and 83 (2%) died from prostate cancer. There were 1 600 (40%) men with PSMs. In unadjusted models, PSMs were significantly associated with all adverse outcomes: BCR, CRPC, metastases and PCSM (all P ≤ 0.001). After adjusting for demographic and pathological characteristics, PSMs were associated with increased risk of only BCR (HR 1.98, P < 0.001), and not CRPC, metastases, or PCSM (HR ≤1.29, P > 0.18). Similar results were seen when stratified by pathological Gleason score, stage, or PSA level, and when patients who underwent adjuvant radiotherapy were excluded.

Conclusions

PSMs after RP are not an independent risk factor for CRPC, metastasis, or PCSM overall or within any subset. In the absence of other high-risk features, PSMs alone may not be an indication for adjuvant radiotherapy.

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Video: Effects of clomiphene citrate isomers on mouse reproductive tissues

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Differential effects of isomers of clomiphene citrate on reproductive tissues in male mice

Gregory K. Fontenot, Ronald D. Wiehle and Joseph S. Podolski

 

Repros Therapeutics Inc., The Woodlands, TX, USA

 

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Objectives

To determine, in a chronic dosing study, the oral toxicity potential of the test substances, enclomiphene citrate (ENC) and zuclomiphene citrate (ZUC), when administered to male mice by oral gavage.

Materials and Methods

Mice were divided into five treatment groups. Group I, placebo; Group II, 40 mg/kg body weight/day ENC; Group III, 4 mg/kg/day ENC; Group IV, 40 mg/kg/day ZUC; Group V, 4 mg/kg/day ZUC. Serum samples and tissues were obtained from each mouse for analysis and body weights were measured.

Results

In this chronic dosing study in mice, profound effects on Leydig cells, epididymis, seminal vesicles, and kidneys were seen, as well as effects on serum testosterone, follicle-stimulating hormone and luteinising hormone levels that were associated with ZUC treatment only. Treatment with the isolated enclomiphene isomer had positive effects on testosterone production and no effects on testicular histology.

Conclusions

The present study suggests that an unopposed high dose of zuclomiphene can have pernicious effects on male mammalian reproductive organs. The deleterious effects seen when administering ZUC in male mice, justifies the case for a monoisomeric preparation and the development of ENC for clinical use in human males to increase serum levels of testosterone and maintain sperm counts.

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Video: Tolterodine combined with an alpha-blocker in men with LUTS and OAB

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Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an α-blocker in men with lower urinary tract symptoms (LUTS) and overactive bladder: a randomized controlled trial

Tae Heon Kim*, Wonho Jung†, Yoon Seok Suh*, Soonhyun Yook‡, Hyun Hwan Sung*
and Kyu-Sung Lee*‡
*Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, †Department of Urology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, and ‡Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea Tae Heon Kim and Wonho Jung contributed equally to this work.

 

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Objective
To evaluate the efficacy and safety of low-dose (2 mg) tolterodine extended release (ER) with an a-blocker compared with standard-dose (4 mg) tolterodine ER with an α-blocker for the treatment of men with residual storage symptoms after α-blocker monotherapy.
Patients and Methods
The study was a 12-week, single-blind, randomized, parallel group, non-inferiority trial that included men with residual storage symptoms despite receiving at least 4 weeks of α-blocker
treatment. Inclusion criteria were total International Prostate Symptom Score (IPSS) ≥12, IPSS quality-of-life item score ≥3, and ≥8 micturitions and ≥2 urgency episodes per 24 h. The primary outcome was change in the total IPSS score from baseline. Bladder diary variables, patient-reported
outcomes and safety were also assessed.
Results
Patients were randomly assigned to addition of either 2 mg tolterodine ER (n = 47) or 4 mg tolterodine ER (n = 48) to α-blocker therapy for 12 weeks. Patients in both treatment groups had a significant improvement in total IPSS score (5.5 and 6.3, respectively), micturition per 24 h (1.3 and
1.7, respectively) and nocturia per night (0.4 and 0.4, respectively). Changes in IPSS, bladder diary variables, and patient-reported outcomes were not significantly different between the treatment groups. All interventions were well tolerated by patients.
Conclusions
These results suggest that 12 weeks of low-dose tolterodine ER add-on therapy is similar to standard-dose tolterodine ER add-on therapy in terms of efficacy and safety for patients experiencing residual storage symptoms after receiving α-blocker monotherapy.

Video: DaPeCa-1 – Diagnostic Accuracy of SNB in Penile Cancer

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DaPeCa-1:  Diagnostic Accuracy of Sentinel Node Biopsy in 222 Penile Cancer Patients at four Tertiary Referral Centres — a National Study from Denmark

Jakob K. Jakobsen*, Kim P. Krarup†, Peter Sommer†, Henrik Nerstrøm†, Vivi Bakholdt‡, Jens A. Sørensen‡, Kasper Ø. Olsen*, Bjarne Kromann-Andersen§, Birgitte G. Toft¶, Søren Høyer**, Kirsten Bouchelouche†† and Jørgen B. Jensen*

 

*Departments of Urology, **Pathology, ††Nuclear Medicine and PET-Centre, Aarhus University Hospital, Aarhus, †Departments of Urology, Pathology, Copenhagen University Hospital, Copenhagen, ‡Department of Plastic Surgery, Odense University Hospital, Odense, and §Department of Urology, Herlev University Hospital, Herlev, Denmark

 

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OBJECTIVES

To estimate the diagnostic accuracy of sentinel lymph node biopsy (SNB) in patients with penile cancer and assess SNB complications in a national multicentre setting.

PATIENTS AND METHODS

Retrospectively data were collected from records in four university centres by one medical doctor covering all SNBs performed in Denmark between 1 January 2000 and 31 December 2010. Patients had either impalpable lymph nodes (LNs) in one or both groins, or had a palpable inguinal mass from which aspiration cytology failed to reveal malignancy. Patients were injected with nanocolloid technetium and had a scintigram recorded before the SNB. The primary endpoint was LN recurrence on follow-up. The secondary endpoint was complications after SNB. Diagnostic accuracy was computed.

RESULTS

In all, 409 groins in 222 patients were examined by SNB. The median (interquartile range) follow-up of patients who survived was 6.6 (5–10) years. Of 343 negative groins, eight were false negatives. The sensitivity was 89.2% (95% confidence interval 79.8–95.2%) per groin. Interestingly, four of 67 T1G1 patients had a positive SNB. In all, 28 of 222 (13%) patients had complications of Clavien-Dindo grade I–IIIa.

CONCLUSION

Penile cancer SNB with a close follow-up stages LN involvement reliably and has few complications in a national multicentre setting. Inguinal LN dissection was avoided in 76% of patients.

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Video: The diagnostic performance of %p2PSA and PHI

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The percentage of prostate-specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

Martin Boegemann*, Carsten Stephan†‡, Henning Cammann§, Sebastien Vincendeau¶, Alain Houlgatte**, Klaus Jung†‡, Jean-Sebastien Blanchet†† and Axel Semjonow*

 

*Department of Urology, Prostate Center, University Medical Centre, Munster, Germany, †Department of Urology, Charite – Universitatsmedizin Berlin, Berlin, Germany, ‡Berlin Institute for Urologic Research, Berlin, Germany, §Institute of Medical Informatics, Charite – Universitatsmedizin Berlin, Berlin, Germany,
Department of Urology, Hospital Pontchallou, Rennes, France, **Department of Urology, HIA du Val de Grace, Paris, France, and ††Department of Scientific Affairs, Beckman Coulter Eurocenter, Nyon, Switzerland

 

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OBJECTIVES

To prospectively test the diagnostic accuracy of the percentage of prostate specific antigen (PSA) isoform [–2]proPSA (%p2PSA) and the Prostate Health Index (PHI), and to determine their role for discrimination between significant and insignificant prostate cancer at initial and repeat prostate biopsy in men aged ≤65 years.

PATIENTS AND METHODS

The diagnostic performance of %p2PSA and PHI were evaluated in a multicentre study. In all, 769 men aged ≤65 years scheduled for initial or repeat prostate biopsy were recruited in four sites based on a total PSA (t-PSA) level of 1.6–8.0 ng/mL World Health Organization (WHO) calibrated (2–10 ng/mL Hybritech-calibrated). Serum samples were measured for the concentration of t-PSA, free PSA (f-PSA) and p2PSA with Beckman Coulter immunoassays on Access-2 or DxI800 instruments. PHI was calculated as (p2PSA/f-PSA × √t-PSA). Uni- and multivariable logistic regression models and an artificial neural network (ANN) were complemented by decision curve analysis (DCA).

RESULTS

In univariate analysis %p2PSA and PHI were the best predictors of prostate cancer detection in all patients (area under the curve [AUC] 0.72 and 0.73, respectively), at initial (AUC 0.67 and 0.69) and repeat biopsy (AUC 0.74 and 0.74). t-PSA and %f-PSA performed less accurately for all patients (AUC 0.54 and 0.62). For detection of significant prostate cancer (based on Prostate Cancer Research International Active Surveillance [PRIAS] criteria) the %p2PSA and PHI equally demonstrated best performance (AUC 0.70 and 0.73) compared with t-PSA and %f-PSA (AUC 0.54 and 0.59). In multivariate analysis PHI we added to a base model of age, prostate volume, digital rectal examination, t-PSA and %f-PSA. PHI was strongest in predicting prostate cancer in all patients, at initial and repeat biopsy and for significant prostate cancer (AUC 0.73, 0.68, 0.78 and 0.72, respectively). In DCA for all patients the ANN showed the broadest threshold probability and best net benefit. PHI as single parameter and the base model + PHI were equivalent with threshold probability and net benefit nearing those of the ANN. For significant cancers the ANN was the strongest parameter in DCA.

CONCLUSION

The present multicentre study showed that %p2PSA and PHI have a superior diagnostic performance for detecting prostate cancer in the PSA range of 1.6–8.0 ng/mL compared with t-PSA and %f-PSA at initial and repeat biopsy and for predicting significant prostate cancer in men aged ≤65 years. They are equally superior for counselling patients before biopsy.

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Video: T1 renal tumours: Partial versus Radical Nephrectomy

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Partial versus Radical Nephrectomy for T1 renal tumours: An analysis from the British Association of Urological Surgeons Nephrectomy Audit

Marios Hadjipavlou, Fahd Khan, Sarah Fowler*, Adrian Joyce†, Francis X. Keeley‡, Seshadri Sriprasad and on behalf of BAUS Sections of Endourology and Oncology

 

Department of Urology, Darent Valley Hospital, Dartford Kent, *British Association of Urological Surgeons, London, †Department of Urology, St James’s University Hospital, Leeds, and ‡Bristol Urological Institute, Southmead Hospital, Bristol, UK

 

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OBJECTIVES

To analyse and compare data from the British Association of Urological Surgeons Nephrectomy Audit for perioperative outcomes of partial (PN) and radical nephrectomy (RN) for T1 renal tumours.

PATIENTS AND METHODS

UK consultants were invited to submit data on all patients undergoing nephrectomy between 1 January and 31 December 2012 to a nationally established database using a standard pro forma. Analysis was made on patient demographics, operative technique, and perioperative data/outcome between PN and RN for T1 tumours.

RESULTS

Overall, data from 6 042 nephrectomies were reported of which 1 768 were performed for T1 renal tumours. Of these, 1 082 (61.2%) were RNs and 686 (38.8%) were PNs. The mean age of patients undergoing PN was lower (PN 59 years vs RN 64 years; P < 0.001) and so was the WHO performance score (PN 0.4 vs RN 0.7; P < 0.001). PN for the treatment of T1a tumours (≤4 cm) accounted for 55.6% of procedures, of which 43.9% were performed using a minimally invasive technique. For T1b tumours (4–7 cm), 18.9% of patients underwent PN, in 33.3% of which a minimally invasive technique was adopted. The vast majority of RNs for T1 tumours were performed using a minimally invasive technique (90.3%). Of the laparoscopic PNs, 30.5% were robot-assisted. There was no significant difference in overall intraoperative complications between the RN and PN groups (4% vs 4.3%; P = 0.79). However, PN accounted for a higher overall postoperative complications rate (RN 11.3% vs PN 17.6%; P < 0.001). RN was associated with a markedly reduced risk of severe surgical complications (Clavien Dindo classification grade ≥3) compared with PN even after adjusting for technique (odds ratio 0.30; P = 0.002). Operation time between RN and PN was comparable (141 vs 145 min; P = 0.25). Blood loss was less in the RN group (mean for RN 165 vs PN 323 mL; P < 0.001); however, transfusion rates were similar (3.2% vs 2.6%; P = 0.47). RN was associated with a shorter length of stay (median 4 vs 5 days; P < 0.001). A direct comparison between robot-assisted and laparoscopic PN showed no significant differences in operation time, blood loss, warm ischaemia time, and intraoperative and postoperative complications.

CONCLUSIONS

PN was the method of choice for treatment of T1a tumours whereas RN was preferred for T1b tumours. Minimally invasive techniques have been widely adopted for RN but not for PN. Despite the advances in surgical technique, a substantial risk of postoperative complications remains with PN.

Video: Step-By-Step: Extended PLND – Creating the Spaces

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Sequencing robot-assisted extended pelvic lymph node dissection prior to radical prostatectomy: a step-by-step guide to exposure and efficiency

Stephen B. Williams, Yasar Bozkurt , Mary Achim, Grace Achim and John W. Davis

 

Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

 

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OBJECTIVE

To describe a novel, step-by-step approach to robot-assisted extended pelvic lymph node dissection (ePLND) at the time of robot-assisted radical prostatectomy (RARP) for intermediate–high risk prostate cancer.

PATIENTS AND METHODS

The sequence of ePLND is at the beginning of the operation to take advantage of greater visibility of the deeper hypogastric planes. The urachus is left intact for an exposure/retraction point. The anatomy is described in terms of lymph nodes (LNs) that are easily retrieved vs those that require additional manipulation of the anatomy, and a determined surgeon. A representative cohort of 167 RARPs was queried for representative metrics that distinguish the ePLND: 146 primary cases and 21 with neoadjuvant systemic therapy.

RESULTS

The median (interquartile range, IQR) LN yield was 22 (16–28) for primary surgeries and 21 (16–23) for neoadjuvant cases. The percentage of cases with positive LNs (pN1) was 16.4% for primary and 29% for neoadjuvant. The hypogastric LNs were involved in 75% of pN1 primary cases and uniquely positive in 33%. Each side of ePLND took the attending surgeon a median (IQR) of 16 (13–20) min and trainees 25 (24–38) min.

CONCLUSIONS

Robot-assisted ePLND before RARP provides an anatomical approach to surgical extirpation mimicking the open approach. We think this sequence offers efficiency and efficacy advantages in high-risk and select intermediate-risk patients with prostate cancer undergoing RARP.

 

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