Independent validation of a pre-specified four-kallikrein marker model for prediction of adverse pathology and biochemical recurrence.

BACKGROUND: Accurate markers for prostate cancer (PC) risk stratification could aid decision-making for initial management strategies. The 4Kscore has an undefined role in predicting outcomes after radical prostatectomy (RP). METHODS: We included 1476 patients with 4Kscore measured prior to RP at two institutions. The 4Kscore was assessed for prediction of adverse pathology at RP and biochemical recurrence (BCR) relative to a clinical model. We pre-specified that all analyses would be assessed in biopsy Grade Group 1 (GG1) or 2 (GG2) PC patients, separately. RESULTS: The 4Kscore increased discrimination for adverse pathology in all patients (delta area under the receiver operative curve (AUC) 0.009, 95% confidence interval (CI) 0.002, 0.016; clinical model AUC 0.767), driven by GG1 (delta AUC 0.040, 95% CI 0.006, 0.073) rather than GG2 patients (delta AUC 0.005, 95% CI -0.012, 0.021). Adding 4Kscore improved prediction of BCR in all patients (delta C-index 0.014, 95% CI 0.007, 0.021; preop-BCR nomogram C-index 0.738), again with larger changes in GG1 than in GG2. CONCLUSIONS: This study validates prior investigations on the use of 4Kscore in men with biopsy-confirmed PC. Men with GG1 PC and a high 4Kscore may benefit from additional testing to guide treatment selection. Further research is warranted regarding the value of the 4Kscore in men with biopsy GG2 PC.

Intracorporeal urinary diversion during robot-assisted radical cystectomy using indocyanine green.

INTRODUCTION To describe the feasibility of total intracorporeal urinary diversion during robotic assisted radical cystectomy using indocyanine green (ICG) and the Firefly system of the da Vinci Xi robot and to evaluate the digestive and urinary outcomes of this technique. MATERIALS AND METHODS: After approval by the Institutional Review Board, we studied all consecutive patients who underwent robotic assisted radical cystectomy (RARC) and intracorporeal urinary derivation (ICUD) with the da Vinci Xi robot using ICG and the Firefly system, in our institution from January 1st 2018 to September 15th 2018. Pre, intra and postoperative data were analyzed with a follow up of at least 1 month. RESULTS: We included 25 patients. Preoperative data were the following: 92 % were men, median age was 74 years (IQR 69-76), 64% of patients had an ASA score ≥ 3. Median operative time was 390 min (IQR 360-460). Median return to bowel function was 3 days for gas (IQR 2-5) and 5 days for stool (IQR 3-6). Median length of hospital stay was 8 days (IQR 7-10). After a median follow up of 9.6 months (IQR 8.3-12.5), only one patient (4%) presented with postoperative obstructive syndrome. There were 2 (8%) urinary leaks and 1 (4%) uretrero-enteric stricture. There were no digestive fistulas recorded. Eleven patients (44%) were readmitted within 90 days for complications. CONCLUSIONS: Total intracorporeal urinary diversion during robotic assisted radical cystectomy using ICG is a feasible technique that might reduce return of bowel function and with low urinary and digestive complications.

Vasa nervorum angiogenesis in prostate cancer with perineural invasion.

BACKGROUND: Perineural invasion (PNI) is generally accepted as a major route of cancer dissemination in malignancies associated with highly enervated organs. However, the effect of cancer cells on vasa nervorum remains unknown. We studied this effect in locally advanced prostate cancer, a high-risk feature associated with approximately 20% of prostate cancer specific mortality. METHODS: We used immunohistochemistry for CD34, fibroblast growth factor-2 (FGF-2), FSHR, podoplanin, vascular endothelial growth factor (VEGF), and VEGFR-2 as well as histochemical methods to examine the vasa nervorum of nerves invaded by cancer cells in tissue samples from 85 patients. RESULTS: The percentage of the nerve area occupied by CD34-positive vasa nervorum endothelial cells in nerves with PNI was much higher than in nerves without PNI (7.3 ± 1.2 vs 1.9 ± 0.4; P < 0.001 and 5.8 ± 0.6 vs 1.23 ± 0.8; P < 0.001 in pT3a and pT3b prostate cancer specimens, respectively). In 19/85 of the patients the CD34-positive vasa nervorum microvessels have a thick basement membrane, similar to the vessels in diabetic microangiopathy. This subendothelial layer contains collagen fibers. Vasa nervorum endothelia and Schwann cells express FGF-2 (nuclear localization) and FSHR (plasma membrane and cytoplasmic staining). Prostate cancer cells invading nerves express VEGF, a critical cytokine in tumor angiogenesis. The vasa nervorum of prostatic nerves with PNI did not express detectable levels of VEGFR-2. No podoplanin-positive lymphatic vessels were seen in nerves. CONCLUSION: In locally advanced prostate cancer, PNI of cancer cells is associated with formation of new endoneurial capillaries and changes of vasa nervorum morphology.

Development of Nomograms to Predict the Recovery of Erectile Function Following Radical Prostatectomy.

INTRODUCTION: Given the number of confounders in predicting erectile function recovery after radical prostatectomy (RP), a nomogram predicting the chance to be functional after RP would be useful to patients' and clinicians' discussions. AIM: To develop preoperative and postoperative nomograms to aid in the prediction of erectile function recovery after RP. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile function domain score-based erectile function. METHODS: A prospective quality-of-life database was used to develop a series of nomograms using multivariable ordinal logistic regression models. Standard preoperative and postoperative factors were included. MAIN OUTCOME MEASURES: The nomograms predicted the probability of recovering functional erections (erectile function domain scores ≥24) and severe erectile dysfunction (≤10) 2 years after RP. RESULTS: 3 nomograms have been developed, including a preoperative, an early postoperative, and a 12-month postoperative version. The concordance indexes for all 3 exceeded 0.78, and the calibration was good. CLINICAL IMPLICATIONS: These nomograms may aid clinicians in discussing erectile function recovery with patients undergoing RP. STRENGTHS & LIMITATIONS: Strengths of this study included a large population, validated instrument, nerve-sparing grading, and nomograms that are well calibrated with excellent discrimination ability. Limitations include current absence of external validation and an overall low comorbidity index. CONCLUSIONS: It is hoped that these nomograms will allow for a more accurate discussion between patients and clinicians regarding erectile function recovery after RP. Mulhall JP, Kattan MW, Bennett NE, et al. Development of Nomograms to Predict the Recovery of Erectile Function Following Radical Prostatectomy J Sex Med 2019;16:1796-1802.

Outcomes after salvage radical prostatectomy and first-line radiation therapy or HIFU for recurrent localized prostate cancer: results from a multicenter study.

INTRODUCTION: Despite no consensus on the optimal management of recurrent prostate cancer after primary radiation or HIFU therapy, salvage prostatectomy (sRP) is reserved for only 3% of patients because of technical challenges and frequent post-operative complications. We assessed outcomes after sRP in a series of patients with localized PCa and that had received radiation therapy or HIFU as a first-line treatment. MATERIALS AND METHODS: Data from nine French referral centers on patients treated with sRP between 2005 and 2017 were collected. Pre- and post-operative data, including oncological and functional outcomes after first treatment and sRP, were analyzed to determine the predictors for biochemical recurrence (BCR) and cancer-specific survival (CSS) after sRP. RESULTS: First-line treatments were external beam-radiation therapy (EBRT) for 30 (55%), brachytherapy (BT) for 10 (18%), and high-intensity focused ultrasound (HIFU) for 15 (27%). Median (IQR) PSA at diagnosis was 6.4 (4.9-9.5) ng/mL, median PSA at nadir was 1.9 (0.7-3.0) ng/mL, and median (IQR) to first BCR was 13 (6-20) months. Of the 55 patients, 44 (80%) received robot-assisted salvage radical prostatectomy and 11 (20%) received salvage retropubic radical prostatectomy. Restoration of continence was achieved in 90% of preoperatively continent patients; 24% that had received nerve-sparing (NS) procedures were potent after surgery. Prolonged catheterization due to anastomotic leakage was the most common complication. Age, preoperative clinical stage, NS procedure, and a pathological Gleason score were predictors for BCR. CONCLUSIONS: sRP was safe, feasible, and effective using either an open or robot-assisted approach, in experienced hands. Age, preoperative clinical stage, NS procedure, and pathological GS were linked with BCR after sRP.

Impact of hospital volume and surgeon volume on robot-assisted partial nephrectomy outcomes: a multicentre study.

OBJECTIVE: To assess the impact of hospital volume (HV) and surgeon volume (SV) on perioperative outcomes of robot-assisted partial nephrectomy (RAPN). PATIENTS AND METHODS: All consecutive patients who underwent a RAPN from 2009 to 2015, at 11 institutions, were included in a retrospective study. To evaluate the impact of HV, we divided RAPN into four quartiles according to the caseload per year: low HV (<20/year), moderate HV (20-44/year), high HV (45-70/year), and very high HV (>70/year). The SV was also divided into four quartiles: low SV (<7/year), moderate SV (7-14/year), high SV (15-30/year), and very high SV (>30/year). The primary endpoint was the Trifecta defined as the following combination: no complications, warm ischaemia time (WIT) <25 min, and negative surgical margins. RESULTS: In total, 1 222 RAPN were included. The mean (sd) caseload per hospital per year was 44.9 (26.7) RAPNs and the mean (sd) caseload per surgeon per year was 19.2 (14.9) RAPNs. The Trifecta achievement rate increased significantly with SV (69.9% vs 72.8% vs 73% vs 86.1%; P < 0.001) and HV (60.3% vs 72.3% vs 86.2% vs 82.4%; P < 0.001). The positive surgical margins (PSM) rate (P = 0.02), length of hospital stay (LOS; P < 0.001), WIT (P < 0.001), and operative time (P < 0.001), all decreased significantly with increasing SV. The PSM rate (P = 0.02), LOS (P < 0.001), WIT (P < 0.001), operative time (P < 0.001), and major complications rate (P = 0.01), all decreased significantly with increasing HV. In multivariate analysis adjusting for HV and SV (model 3), HV remained the main predictive factor of Trifecta achievement (odds ratio [OR] 3.70 for very high vs low HV; P < 0.001), whereas SV was not associated with Trifecta achievement (OR 1.58 for very high vs low SV; P = 0.34). CONCLUSION: In this multicentre study HV and SV both greatly influenced RAPN perioperative outcomes, but HV appeared to have a greater impact than SV.

A multi-institutional evaluation of active surveillance for low risk prostate cancer.

PURPOSE: For select men with low risk prostate cancer active surveillance is more often being considered a management strategy. In a multicenter retrospective study we evaluated the actuarial rates and predictors of remaining on active surveillance, the incidence of cancer progression and the pathological findings of delayed radical prostatectomy. MATERIALS AND METHODS: A cohort of 262 men from 4 institutions met the inclusion criteria of age 75 years or younger, prostate specific antigen 10 ng/ml or less, clinical stage T1-T2a, biopsy Gleason sum 6 or less, 3 or less positive cores at diagnostic biopsy, repeat biopsy before active surveillance and no treatment for 6 months following the repeat biopsy. Active surveillance started on the date of the second biopsy. Actuarial rates of remaining on active surveillance were calculated and univariate Cox regression was used to assess predictors of discontinuing active surveillance. RESULTS: With a median followup of 29 months 43 patients ultimately received active treatment. The 2 and 5-year probabilities of remaining on active surveillance were 91% and 75%, respectively. Patients with cancer on the second biopsy (HR 2.23, 95% CI 1.23-4.06, p = 0.007) and a higher number of cancerous cores from the 2 biopsies combined (p = 0.002) were more likely to undergo treatment. Age, prostate specific antigen, clinical stage, prostate volume and number of total biopsy cores sampled were not predictive of outcome. Skeletal metastases developed in 1 patient 38 months after starting active surveillance. Of the 43 patients undergoing delayed treatment 41 (95%) are without disease progression at a median of 23 months following treatment. CONCLUSIONS: With a median followup of 29 months active surveillance for select patients appears to be safe and associated with a low risk of systemic progression. Cancer at restaging biopsy and a higher total number of cancerous cores are associated with a lower likelihood of remaining on active surveillance. A restaging biopsy should be strongly considered to finalize eligibility for active surveillance.

Prediction of true nodal status in patients with pathological lymph node negative upper tract urothelial carcinoma at radical nephroureterectomy.

PURPOSE: The role of lymph node dissection is still controversial in patients treated with radical nephroureterectomy for upper tract urothelial cancer. We developed a pathological nodal staging model that allows quantification of the likelihood that a patient with pathologically node negative disease has, indeed, no lymph node metastasis. MATERIALS AND METHODS: We analyzed data on 814 patients treated with radical nephroureterectomy and lymph node dissection, and estimated the sensitivity of pathological nodal staging using a ß-binomial model. We developed a pathological nodal staging score that represents the probability that a case is correctly staged as node negative. RESULTS: A median of 5 lymph nodes (range 1 to 46) was removed and 593 patients (73%) had pN0 disease. The probability of missing lymph node metastasis decreased as the number of nodes examined increased. If only a single node was examined, 44% of patients would have been misclassified as having pN0 disease while harboring lymph node metastasis. Even when 5 nodes were examined, 12% of patients would have been misclassified. The proportion of those with a positive node increased with advancing pathological T stage and lymphovascular invasion. Patients with pT0-Ta-Tis-T1/lymphovascular invasion had more than a 95% chance of correct pathological nodal staging with 2 examined nodes. However, if a patient had pT3-T4 and positive lymphovascular invasion, even 20 examined lymph nodes did not attain 95% accuracy. CONCLUSIONS: Lymph node dissection provides more accurate staging and prediction of survival. The number of examined nodes needed for adequate staging depends on pT stage and lymphovascular invasion. We developed a tool to estimate the likelihood of false-negative lymph node metastasis, which could help refine clinical decision making regarding the administration of adjuvant chemotherapy.

Predictors of survival in patients with soft tissue surgical margin involvement at radical cystectomy.

BACKGROUND: The presence of positive soft tissue surgical margins (STSM) at radical cystectomy (RC) is rare. Although some patients with STSM experience disease recurrence rapidly, some have long-term local disease control. We sought to describe the oncologic outcomes, identify predictors, and assess the impact of location and multifocality in patients with positive STSMs at RC. METHODS: We retrospectively collected the data of 4,335 patients treated with RC and pelvic lymphadenectomy at 11 academic centers from 1981 to 2008. STSM was defined as the presence of tumor at inked areas of soft tissue on the RC specimen. Univariate and multivariate Cox regression models addressed recurrence-free survival and cancer-specific survival after surgery. RESULTS: STSM were identified in 231 patients (5%). Actuarial recurrence-free survival estimates at 2 and 5 years after RC were 26 ± 3 and 21 ± 3%, respectively. Actuarial cancer-specific survival estimates at 2 and 5 years after RC were 33 ± 3 and 25 ± 4%, respectively. Higher body mass index (p = 0.050), higher tumor stage (p = 0.017), presence of grade 3 disease (p = 0.046), lymphovascular invasion (p = 0.003), and lymph node involvement (p = 0.003) were all independently associated with disease recurrence. Furthermore, higher tumor stage (p = 0.015), lymphovascular invasion (p = 0.006), and lymph node involvement (p = 0.006) were independently associated with cancer specific mortality. Location and multifocality of STSM were not associated with outcomes. CONCLUSIONS: Although most patients with STSM at RC had poor outcomes, more than one-fifth had durable cancer control. Pathologic features associated with disease recurrence in the general RC population also stratify patients with STSM into differential risk groups.

Robot-Assisted Laparoscopic Prostatectomy Experience and Pathological Quality: Are They Always Linked?

Objective: We investigated whether pathological outcomes improved with experience and surgeon generation after robot-assisted laparoscopic prostatectomy (RALP). Materials and Methods: The study included 1338 patients who underwent RALP between February 2010 and April 2020. We created learning curves for pelvic lymph node dissection (PLND), number of lymph nodes (LNs) removed, and positive surgical margin (PSM) after adjustment for confounders. We compared the outcomes between the first and second generation of surgeons in regression models. Results: The learning curve regarding PLND indications showed a significant increase with experience for the first generation, whereas the second generation had a learning curve that remained flat at a higher level (92.3%) and significantly better than the first generation (p < 0.001). Similarly, the number of LN removed showed a significant increase with experience in both generations, but the overall median number of LN removed was significantly higher in the second generation compared with the first generation (12 vs 10, p < 0.001). However, the learning curve for PSM remained flat at ∼20% after adjustment and did not show improvement with experience in both generations of surgeons (p = 0.794). Conclusions: Surgeons showed improvement with experience and education with RALP with respect to the indications for PLND and number of LNs removed. However, there was no improvement over time and generations for PSM. Experience based solely on the number of patients operated on is not an intrinsic factor in the pathological quality of RALP. Factors other than experience may also play a role in oncologic improvement.

Nodal counts during pelvic lymph node dissection for prostate cancer: an objective indicator of quality under the influence of very subjective factors.

UNLABELLED: Study Type--Therapy (case series). Level of Evidence 4. What's known on the subject? And what does the study add? In lymph node dissections for cancer, the more extended the dissection, the higher the number of lymph nodes removed. In addition, the higher the number of nodes retrieved, the better the staging. This leads many investigators to set a threshold of a minimal number of nodes below which the dissection is considered inadequate. Although the minimal threshold concept is generally good, it is not based on very objective data. a number of factors might influence the final number of nodes removed: (i) the surgeon and the surgical technique; (ii) the pathologists and tissue processing technique; (iii) the patient; and (iv) the audit effect and feedback to the surgeons about the number of nodes removed. OBJECTIVE: • To examine the number of lymph nodes removed over time for men undergoing a standard pelvic lymph node dissection (PLND) during radical prostatectomy. PATIENTS AND METHODS: • In total, 2119 consecutive patients with clinically localized prostate cancer were scheduled for non-salvage radical prostatectomy between February 2005 and September 2009. • All patients underwent PLND, including the external iliac, hypogastric and obturator fossa nodal groups. • We tested whether the number of lymph nodes increased over time by including the date of each patient's surgery into a linear regression model using nonlinear terms. RESULTS: • From 2008 onward, there appears to be a large increase in the number of nodes removed. • Date of surgery was a significant predictor of the number of nodes removed (P < 0.001). • The anatomical template of dissection, the specimen submission and pathological assessment were reportedly unchanged. • The nodal yield increase in the later part of the study coincides with an increase in the academic interest in PLND and nodal metastasis in prostate cancer at the institutional level and worldwide. CONCLUSIONS: • Without any intentional change in surgical technique or pathological processing, the number of lymph nodes removed in our radical prostatectomy experience increased. • This change coincided with an increased academic interest in the subject and highlights the positive feedback effect. • The change also raises concerns about unaccounted for confounding factors that could affect multi-institutional datasets and surgical clinical trials.

Role of prostate specific antigen and immediate confirmatory biopsy in predicting progression during active surveillance for low risk prostate cancer.

PURPOSE: We evaluated predictors of progression after starting active surveillance, especially the role of prostate specific antigen and immediate confirmatory prostate biopsy. MATERIALS AND METHODS: A total of 238 men with prostate cancer met active surveillance eligibility criteria and were analyzed for progression with time. Cox proportional hazards regression was used to evaluate predictors of progression. Progression was evaluated using 2 definitions, including no longer meeting 1) full and 2) modified criteria, excluding prostate specific antigen greater than 10 ng/ml as a criterion. RESULTS: Using full criteria 61 patients progressed during followup. The 2 and 5-year progression-free probability was 80% and 60%, respectively. With prostate specific antigen included in progression criteria prostate specific antigen at confirmatory biopsy (HR 1.29, 95% CI 1.14-1.46, p <0.0005) and positive confirmatory biopsy (HR 1.75, 95% CI 1.01-3.04, p = 0.047) were independent predictors of progression. Of the 61 cases 34 failed due to increased prostate specific antigen, including only 5 with subsequent progression by biopsy criteria. When prostate specific antigen was excluded from progression criteria, only 32 cases progressed, and 2 and 5-year progression-free probability was 91% and 76%, respectively. Using modified criteria as an end point positive confirmatory biopsy was the only independent predictor of progression (HR 3.16, 95% CI 1.41-7.09, p = 0.005). CONCLUSIONS: Active surveillance is feasible in patients with low risk prostate cancer and most patients show little evidence of progression within 5 years. There is no clear justification for treating patients in whom prostate specific antigen increases above 10 ng/ml in the absence of other indications of tumor progression. Patients considering active surveillance should undergo confirmatory biopsy to better assess the risk of progression.

Extending the indications and anatomical limits of pelvic lymph node dissection for prostate cancer: improved staging or increased morbidity?

OBJECTIVE: • To assess, in a risk/benefit analysis, the additional risk for complications and benefits of extending the indications and anatomical limits of pelvic lymph node dissection (PLND). PATIENTS AND METHODS: • In total, 971 consecutive patients with clinically localized prostate cancer underwent laparoscopic radical prostatectomy from 2003-2007. • Before 1 February 2005, patients with a nomogram probability of lymph node invasion (LNI) <2% did not undergo PLND (No PLND group), whereas those with a LNI ≥ 2% had a PLND limited to the external iliac nodal group (limited PLND group). • After 1 February 2005, all patients underwent a standard PLND including the external iliac, hypogastric and obturator fossa nodal groups (standard PLND group). • The risk parameters were PLND-related complications and operating time. Complications were graded using a modified Clavien classification. The benefit was the detection of nodal metastases. RESULTS: • In the subgroup of patients with a LNI ≥ 2%, standard PLND was a superior operation than the limited PLND in detecting nodal metastases (14.3% vs 4.5%, respectively; P = 0.003). • The risk/benefit of standard vs limited PLND would be one additional grade 3 complication per 20 additional patients with nodal metastases. In the subgroup of patients with LNI <2%, three patients (1.0%) had positive nodes after a standard PLND. • The risk/benefit of standard PLND vs no PLND would be one additional grade 3 complication per three or four additional patients with nodal metastasis. The no PLND group was associated with the lowest risk of grade 1, 2 and 3 complications compared to either the limited or standard PLND groups (P < 0.001). CONCLUSIONS: • In patients with LNI ≥ 2%, standard PLND detects more nodal metastasis. PLND is associated with higher but non-prohibitive complications rate. • The present study found no evidence that the incidence of complications would be reduced by a limited PLND.

Pilot study of salvage laparoscopic prostatectomy for the treatment of recurrent prostate cancer.

OBJECTIVE: • To evaluate feasibility, safety and oncological efficacy of salvage laparoscopic radical prostatectomy for pathology-proven biochemical recurrence after primary radiation therapy or cryotherapy for prostate cancer. MATERIALS AND METHODS: • This retrospective pilot study examined 15 patients from 2004 to 2010 with biochemical recurrence after external beam radiation therapy (N= 8), brachytherapy (N= 6) or cryotherapy (N= 1). • Patients were treated with salvage laparoscopic radical prostatectomy (11 conventional, four robotic-assisted) with bilateral pelvic dissection. RESULTS: • Median duration of surgery was 235 min. None of the following occurred: conversion to open surgery, transfusion, urethrovesical stenosis or perioperative or postoperative mortality. One patient presented with a rectal injury, repaired using uninterrupted sutures and a colostomy. One patient had anastomotic leak treated with prolonged Foley catheterization. • Pathological stage was pT2a in three, pT2b in three, pT3a in four, pT3b in three and pT4 in two patients; two patients had nodal metastasis. Within an 8-month median follow-up, 11 patients were disease-free and three had persistent postoperative prostate-specific antigen (PSA) elevation; the remaining patient experienced PSA recurrence after 21 months. • Seven patients achieved continence (no pads) by 8.4 months (median), one patient manifested severe incontinence corrected by implanting an artificial sphincter, and seven patients with a 12.6-month mean follow-up continued to need one or two pads per day. • Erectile dysfunction was present in five patients before surgery and in 14 patients after surgery. CONCLUSION: • Salvage laparoscopic radical prostatectomy seems to offer a safe therapeutic alternative for patients failing primary radiation or cryotherapy. However, larger studies with longer-term data are required.

Subjective characterization of nerve sparing predicts recovery of erectile function after radical prostatectomy: defining the utility of a nerve sparing grading system.

INTRODUCTION: Radical prostatectomy (RP) is a common technique for managing prostate cancer. Concern regarding functional outcomes in patients prompted the development of nerve sparing to improve recovery of erectile function. AIM: To assess if a cumulative nerve damage grading system is a more precise predictor of recovery of erectile function as compared to the current "all-or-none" grading system. METHODS: Baseline demographic, medical history, and International Index of Erectile Function (IIEF)-erectile function domain (EFD) scores were collected. At the time of RP, patients were assigned a nerve sparing score (NSS) by their surgeon for each neurovascular bundle (left and right) to assess the quality of intraoperative nerve sparing (1-complete preservation, 4-complete resection). Patients completed IIEF questionnaires at 24 months after RP. MAIN OUTCOME MEASURES: Group comparisons and multiple regression analyses were used to test the association between the NSS and IIEF-EFD scores for patients with preoperative EFD scores ≥ 24. RESULTS: A total of 173 patients were included in this analysis. Mean age for patients was 59, and 62% of patients had at least one comorbidity. Baseline EFD scores were comparable between all NSS assignments. At 24 months, EFD scores were reduced by 7.2, 11.6, 13.9, and 15.4 points for patients with NSS grades of 2, 3, 4, and 5-8, respectively (P < 0.01). Multivariate analysis demonstrated lower NSS predicted recovery of erectile function at 24 months (P = 0.001), as did age (P = 0.001) and baseline EFD score (P = 0.02). CONCLUSION: Our data support the adoption of a subjectively assigned NSS to more precisely predict erectile function outcomes and suggest that even minor nerve trauma significantly impairs the recovery of erectile function after procedures classically regarded as having achieved bilateral nerve sparing. Further studies are needed to identify the optimal NSS system.

Predictors of symptomatic lymphocele after radical prostatectomy and bilateral pelvic lymph node dissection.

OBJECTIVES: Lymphocele is the most common complication of pelvic lymphadenectomy (PLND). We sought to determine predictors of symptomatic lymphocele after radical prostatectomy (RP) and PLND, and in particular, to determine if the number of drains placed represents an independent predictor. METHODS: Between January 1999 and June 2007, 4173 consecutive patients underwent bilateral PLND at the time of either open or laparoscopic RP. Lymphoceles were identified in patients undergoing imaging as a result of symptoms suspicious for lymphocele, such as fever, abdominal pain or lower extremity swelling. Routine postoperative imaging was not carried out. Cox proportional hazards analysis was carried out using forced variable entry to obtain maximum likelihood estimates of the hazard ratios and 95% confidence intervals using the number of drains placed, number of nodes removed, RP approach and use of prophylactic low-molecular-weight heparin (LMWH) as predictors of symptomatic lymphocele. RESULTS: There were 164 patients (4%) with a symptomatic lymphocele on follow up, with a median time to presentation of 19 days. The primary presenting complaints were fever in 47%, abdominal pain in 40%, lower extremity swelling in 37%, genital swelling in 25%, groin pain in 22%, abdominal swelling in 9%, and back and flank pain in 6% and 5%, respectively. Median lymphocele diameter was 5 cm. Significant predictors of symptomatic lymphocele on multivariate analysis included number of nodes removed and use of LMWH, but not number of drains placed. CONCLUSIONS: Use of prophylactic LMWH and a higher node count are predictive of a higher incidence of symptomatic lymphocele after RP and PLND.

Comparative effectiveness of prostate cancer surgical treatments: a population based analysis of postoperative outcomes.

PURPOSE: Enthusiasm for laparoscopic surgical approaches to prostate cancer treatment has grown despite limited evidence of improved outcomes compared with open radical prostatectomy. We compared laparoscopic prostatectomy with or without robotic assistance vs open radical prostatectomy in terms of postoperative outcomes and subsequent cancer directed therapy. MATERIALS AND METHODS: Using a population based cancer registry linked with Medicare claims we identified men 66 years old or older with localized prostate cancer who underwent radical prostatectomy from 2003 to 2005. Outcome measures were general medical/surgical complications and mortality within 90 days after surgery, genitourinary/bowel complications within 365 days, radiation therapy and/or androgen deprivation therapy within 365 days and length of hospital stay. RESULTS: Of the 5,923 men 18% underwent laparoscopic radical prostatectomy. Adjusting for patient and tumor characteristics, there were no differences in the rate of general medical/surgical complications (OR 0.93 95% CI 0.77-1.14) or genitourinary/bowel complications (OR 0.96 95% CI 0.76-1.22), or in postoperative radiation and/or androgen deprivation (OR 0.80 95% CI 0.60-1.08). Laparoscopic prostatectomy was associated with a 35% shorter hospital stay (p <0.0001) and a lower bladder neck/urethral obstruction rate (OR 0.74, 95% CI 0.58-0.94). In laparoscopic cases surgeon volume was inversely associated with hospital stay and the odds of any genitourinary/bowel complication. CONCLUSIONS: Laparoscopic prostatectomy and open radical prostatectomy have similar rates of postoperative morbidity and additional treatment. Men considering prostate cancer surgery should understand the expected benefits and risks of each technique to facilitate decision making and set realistic expectations.

The learning curve for laparoscopic radical prostatectomy: an international multicenter study.

PURPOSE: It is not yet possible to estimate the number of cases required for a beginner to become expert in laparoscopic radical prostatectomy. We estimated the learning curve of laparoscopic radical prostatectomy for positive surgical margins compared to a published learning curve for open radical prostatectomy. MATERIALS AND METHODS: We reviewed records from 8,544 consecutive patients with prostate cancer treated laparoscopically by 51 surgeons at 14 academic institutions in Europe and the United States. The probability of a positive surgical margin was calculated as a function of surgeon experience with adjustment for pathological stage, Gleason score and prostate specific antigen. A second model incorporated prior experience with open radical prostatectomy and surgeon generation. RESULTS: Positive surgical margins occurred in 1,862 patients (22%). There was an apparent improvement in surgical margin rates up to a plateau at 200 to 250 surgeries. Changes in margin rates once this plateau was reached were relatively minimal relative to the CIs. The absolute risk difference for 10 vs 250 prior surgeries was 4.8% (95% CI 1.5, 8.5). Neither surgeon generation nor prior open radical prostatectomy experience was statistically significant when added to the model. The rate of decrease in positive surgical margins was more rapid in the open vs laparoscopic learning curve. CONCLUSIONS: The learning curve for surgical margins after laparoscopic radical prostatectomy plateaus at approximately 200 to 250 cases. Prior open experience and surgeon generation do not improve the margin rate, suggesting that the rate is primarily a function of specifically laparoscopic training and experience.

Location and number of positive surgical margins as prognostic factors of biochemical recurrence after salvage radiation therapy after radical prostatectomy.

OBJECTIVE: To determine if the location and number of positive surgical margins (PSMs) after radical prostatectomy (RP) are associated with recurrence after salvage external beam radiation therapy (sEBRT). PATIENTS AND METHODS: We retrospectively reviewed the medical records of 60 patients with PSMs who underwent three-dimensional conformal sEBRT for biochemical recurrence (BCR) or clinically detected local recurrence after RP between 1996 and 2007. PSMs were categorized as present or absent at three locations, and patients were classified as having either one or more than one PSM. BCR after RP was defined as a prostate-specific antigen (PSA) level of ≥ 0.1 ng/mL. BCR after sEBRT was defined as a serum PSA level of ≥ 0.1 ng/mL above the PSA nadir after sEBRT. RESULTS: In all, 24 (40%) patients had more than one PSM. Overall, the most common location of a PSM was the posterior prostate with 40 (66%) patients having a positive posterior margin. The location of PSMs was not significantly associated with secondary BCR (global P= 0.8). There was a borderline result between the number of PSMs and BCR: men with more than one PSM were less likely to recur compared with those with only one PSM (hazard ratio 0.42; P= 0.067). CONCLUSIONS: This is the first study to specifically analyse location and number of PSMs as prognostic factors for men who undergo sEBRT. There was no evidence to suggest that the location of a PSM predicted secondary BCR. Further research is needed to determine whether the number of PSMs is an important predictor of BCR after sEBRT.

The depth of the prostatic apex is an independent predictor of positive apical margins at radical prostatectomy.

OBJECTIVE: To determine the effect of a deep and narrow pelvis on apical positive surgical margins (PSM) at radical prostatectomy (RP), controlling for other clinical and pathological variables and surgical approach, i.e. open retropubic (RRP) vs laparoscopic (LRP), as apical dissection is expected to be more challenging at RP with a prostate situated deep in a narrow pelvis. PATIENTS AND METHODS: From July 2003 to January 2005, 512 consecutive patients with preoperative prostate magnetic resonance imaging (MRI) underwent RRP or LRP with no previous radio- or hormonal therapy. An additional 74 patients with preoperative MRI undergoing RP from December 2001 to June 2007 who had an apical PSM were also included, with 586 patients comprising the study population. Bony and soft-tissue pelvic dimensions, including interspinous distance (ISD), bony (BFW) and soft tissue (SW) pelvic width, apical prostate depth (AD) and symphysis pubis angle, were measured on preoperative MRI. The pelvic dimension index (PDI), bony width index (BWI) and soft-tissue width index (SWI) were defined as ISD/AD, BFW/AD and SW/AD, respectively. Multivariate logistic regression was used to assess the effect of pelvic dimensions on apical PSM, controlling for surgical approach and clinical and pathological variables. RESULTS: There was no significant difference in ISD, BFW, SW or symphysis angle between patients with and without apical PSM. The AD was significantly greater in men with an apical PSM and consequently PDI, BWI and SWI were significantly lower in men with an apical PSM. Each of PDI, AD, BWI and SWI was a significant independent predictor of apical PSM, independent of surgical approach, and other clinicopathological variables. The main limitations of the study were that it was retrospective, and the relatively few patients with apical PSM. CONCLUSIONS: Apical prostate depth is an independent risk factor for apical PSM at RP. MRI pelvimetry might allow for preoperative planning of the approach to RP.