Robot-assisted vs open retropubic radical prostatectomy: a propensity score-matched comparative analysis based on 15 years and 18,805 patients.

PURPOSE: To compare oncological, functional, and surgical outcomes of a large cohort of patients who underwent open retropubic radical prostatectomy (ORP) or robot-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: Data from 18,805 RPs performed with either the open or the robot-assisted approaches at a single tertiary referral center between 2008 and 2022 were analyzed. The impact of surgical approach on biochemical recurrence-free survival, salvage radiotherapy-free survival, and metastasis-free survival was analyzed by log-rank test and Kaplan-Meier analysis in a propensity score (PS)-based matched cohort. Intraoperative and postoperative surgical outcomes were assessed. One-week, 3-month, and 12-month continence rates and 12-month erectile function (EF) were analyzed. RESULTS: No statistically significant differences in oncological outcomes were found between ORP and RARP. A slight statistically significant difference in favor of RARP was noted in urinary continence at 3 months (RARP vs. ORP: 81% vs. 77%, p = 0.007) and 12 months (91% vs. 89.3%, p = 0.008), respectively. The rate of EF was statistically significantly higher (60%) after RARP than after ORP (45%, p < 0.001). CONCLUSION: Both RARP and ORP yielded similar oncological outcomes. RARP offered a slight advantage in terms of continence recovery, but its clinical significance may be less meaningful. RARP resulted in significantly improved postoperative EF, suggesting a potential influence of both surgical experience and minimally invasive approach.

Histopathological results of radical prostatectomy specimen of men younger than 50 years of age at the time of surgery: possible implications for prostate cancer screening programs?

INTRODUCTION: Prostate cancer (PCa) detection is usually achieved by PSA measurement and, if indicated, further diagnostics. The recent EAU guidelines recommend a first PSA test at the age of 50 years, if no family history of PCa or BRCA2 mutation exists. However, some men might harbor significant PCa at younger age; thus we evaluated the histopathological results of men treated with radical prostatectomy (RP) in their 40 s at our institution. MATERIALS AND METHODS: We relied on the data of all patients who underwent RP in our institution between 1992 and 2020 and were younger than 50 years at the time of surgery. The histopathological results are descriptively presented. Moreover, we tested the effect of a positive family history on the descriptive results. RESULTS: Overall, 1225 patients younger than 50 years underwent RP at our institution. Median age was 47 years. Most patients showed favorable histopathological characteristics. However, 20% of patients had extraprostatic disease (≥ pT3a), 15% had ISUP Gleason grade group ≥ 3, and 7% had positive lymph nodes (pN1). Patients with a known positive family history did not have a higher rate of adverse disease as their counterparts with a negative family history. DISCUSSION: Our data show that the majority of patients who were diagnosed with PCa at a very young age had favorable histopathological RP characteristics. However, a non-negligible proportion of patients already showed locally advanced disease and would have probably benefited from earlier PCa detection. This should be kept in mind when PCa screening recommendations are proposed.

Concordance of biopsy and pathologic ISUP grading in salvage radical prostatectomy patients for recurrent prostate cancer.

PURPOSE: To investigate the concordance of biopsy and pathologic International Society of Urological Pathology (ISUP) grading in salvage radical prostatectomy (SRP) patients for recurrent prostate cancer. METHODS: Within a high-volume center database, we identified patients who underwent SRP for recurrent prostate cancer (PCa) between 2004 and 2020. Upgrading, downgrading, concordance, and any discordance between posttreatment biopsy ISUP and ISUP at SRP were tested. Logistic regression models were used to predict ISUP upgrading and ISUP discordance. Models were adjusted for prostatic specific antigen before SRP, age at surgery, initial prostatic specific antigen (PSA), type of primary treatment, time from primary PCa diagnosis to SRP, number of positive cores at biopsy, and original Gleason score. RESULTS: Overall, 184 patients with available biopsy and pathologic ISUP grading were identified. Of those, 17.4% (n = 32), 40.8% (n = 75), 19.6% (n = 36), and 22.2% (n = 41) harbored biopsy ISUP 1, ISUP 2, ISUP 3, and ISUP 4-5 grading, respectively. Pathologic ISUP 1, ISUP 2, ISUP 3, and ISUP 4-5 grading was recorded in 6.0% (n = 11), 40.8% (n = 75), 32.1% (n = 59), and 21.2% (n = 39), respectively. Median PSA before SRP was 5.5 ng/ml (interquartile range [IQR]: 3.1-8.1 ng/ml), median age at SRP was 65.1 years (IQR:60.7-69.4 years) and median time from original PCa diagnosis to SRP was 47 months (IQR: 27.3-85.2 months). Concordance of biopsy and pathologic ISUP was identified in 45.1% (n = 83). Conversely, any ISUP discordance, upgrading and downgrading of at least one ISUP group was identified in 54.9% (n = 101), 35.3% (n = 65), and 19.6% (n = 36). In logistic models, none of the preoperative characteristics was associated with upgrading or ISUP discordance (all p > 0.1). CONCLUSION: Discordance between biopsy and pathologic ISUP grading is common at SRP. However, in 45% of SRP cases biopsy ISUP is capable to predict pathologic ISUP. Further studies are necessary to identify characteristics for ISUP upgrading at SRP.

Preprostatic lymph nodes in prostate cancer hot or not? Impact on oncological outcome after radical prostatectomy.

OBJECTIVE: To assess the impact of preprostatic lymph node invasion on prostate cancer patients' outcome after radical prostatectomy. It is known that invasion of pelvic lymph nodes is associated with worse oncological outcome, but little is known about invasion of preprostatic lymph nodes. We hypothesized that positive preprostatic lymph nodes may not be as harmful as positive pelvic lymph nodes. MATERIALS AND METHODS: A total of 11,107 consecutive patients treated for prostate cancer with radical prostatectomy between 2013 and 2017 were evaluated. 1575 (14.2%) had some type of lymph node invasion, 53 (0.5%) had only one positive preprostatic lymph node and 705 (6.3%) had only one positive pelvic lymph node. RESULTS: Median follow-up was 37.7 months (interquartile range: 24.6-58.7 months). Baseline characteristics of the overall cohort were not statistically significant between the preprostatic vs. pelvic lymph node invasion groups, except for robot-assisted operation (64.2 vs. 32.3%, p < 0.001) and count of removed lymph nodes (16 vs. 19, p < 0.001). There was no statistically significant difference in 3-years biochemical recurrence rate (56.2 vs. 65.8%, p = 0.5), 3-years metastases free survival rate (87.4 vs. 95.5%, p = 0.5) and overall cancer-specific mortality (1.9 vs 1.0%) between the two groups. CONCLUSIONS: Preprostatic lymph node invasion seems to have a similar harmful effect as pelvic lymph node invasion and thus, if detected, may alter treatment and follow-up strategy. Therefore, it is important to perform a histological analysis when removing the preprostatic tissue.

Significant reduction of lymphoceles after radical prostatectomy and pelvic lymph node dissection.

OBJECTIVES: To reduce the risk of symptomatic lymphocele (SLC), we present a technique using peritoneal fenestration that allows lymphatic fluid to drain into the abdomen, as SLC formation after open retropubic radical prostatectomy (ORP) with pelvic lymph node dissection (PLND) is a common adverse event. PATIENTS AND METHODS: We identified 1513 patients who underwent ORP with PLND between July 2018 and November 2019. Of those, 307 patients (20.3%) received peritoneal fenestration and 1206 (79.7%) no fenestration. The rate of LCs and the necessity for intervention were analysed by uni- and multivariable logistic regression (MLR) models. A propensity score matching was performed, as well. RESULTS: The median (interquartile range [IQR]) age was 65 (60-70) years. A median (IQR) of 16 (10-22) lymph nodes were dissected, 22 vs 14 lymph nodes in the fenestration vs non-fenestration group (P < 0.001). Overall, 189 patients (12.5%) were diagnosed with a LC after ORP, while 21 patients (6.8%) in the fenestration and 168 (13.9%) in the non-fenestration group had LCs (P = 0.001). In 70 patients (4.7%), LCs required further intervention, categorised as Clavien-Dindo Grade IIIa/b, with a smaller proportion in the fenestration group (2.9% vs 5.0% in the non-fenestration group, P < 0.001). There were no Clavien-Dindo Grade IV or V complications, in particular no abdominal complications in association with peritoneal fenestration observed. In MLR, peritoneal fenestration was associated with a reduced risk of LCs (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.2-0.5; P < 0.001). The risk reduction was also shown after propensity score matching (OR 0.38, 95% CI 0.21-0.68; P = 0.001). The number needed to treat was 14. CONCLUSIONS: Peritoneal fenestration may decrease the rate of SLC after ORP with (extended) PLND. Therefore, it should be part of the operative strategy.

Comparison of intra- and postoperative analgesia and pain perception in robot-assisted vs. open radical prostatectomy.

PURPOSE: One of the advantages of minimally invasive surgery may be reduced postoperative pain and faster recovery. However, reliable comparisons of robot-assisted (RARP) vs. open radical prostatectomy (ORP) addressing perioperative pain regimen are scarce. METHODS: We identified 420 consecutive treated patients who underwent RARP (n = 254) vs. ORP (n = 166) for clinically localized prostate cancer in 2017. After 1:1 propensity score matching for age, body mass index, D'Amico risk classification and lymph node yield, intra- and postoperative pain medication doses, as well as pain perception expressed by the numeric rating scale were assessed in uni- and multivariable analyses. RESULTS: Median age was 64.9 years. Operation time was significantly shorter in ORP patients (155 vs. 175 min in RARP, p < 0.001). Overall, a median of 12.5 vs. 12 g of metamizol was administered in RARP vs. ORP patients (p = 0.2). Additionally, a median of 146.7 vs. 133.9 mg of morphine equivalent was administered in RARP vs. ORP patients (p < 0.001). The mean maximum pain perceived on day 0 was 3.2 vs. 3.6 in RARP vs. ORP patients (p = 0.1). It decreased within the following days, and again, no differences between the two groups were observed. All results were confirmed in multivariable analyses. CONCLUSIONS: When comparing RARP vs. ORP, a small increase in perioperative morphine administration at RARP may be expected. However, when assessing pain perception, no differences were observed between the two groups. Moreover, mean maximum pain perceived was very low, which may reassure patients, who are counselled for radical prostatectomy.

A comparative study of robot-assisted and open radical prostatectomy in 10 790 men treated by highly trained surgeons for both procedures.

OBJECTIVE: To compare oncological, functional and surgical outcomes of open retropubic radical prostatectomy (ORP) vs robot-assisted laparoscopic radical prostatectomy (RARP). PATIENTS AND METHODS: We identified 10 790 consecutive treated patients within our prospective database (2008-2016) who underwent either ORP (7007 patients) or RARP (3783). All procedures were performed by seven highly trained surgeons performing both surgical approaches regularly. Oncological (48-month biochemical recurrence [BCR] rate), functional (urinary continence, erectile function), and surgical outcomes (rate of nerve-sparing [NS] procedures, lymph node yield, surgical margin [SM] status, length of hospital stay [LOS], operation time, blood loss, transfusion rate, time to catheter removal) were assessed. Kaplan-Meier, multivariable Cox and logistic regression models were used to test for BCR and functional outcome differences. RESULTS: No statistically significant difference regarding oncological outcome distinguished between ORP vs RARP. For functional outcomes, the 1-week continence rates were higher in the ORP group (25.8% vs 21.8%, P < 0.001). At 3 months, no statistically significant differences were observed. At 12 months, continence rates were modestly higher in the RARP group (90.3% vs 88.8%, P = 0.01). This effect was no longer observed after stratification for age-groups. The 12-month potency rates were similar in ORP vs RARP (80.3% vs 83.6%, P = 0.33). For surgical outcomes, there was no significant difference in the rates of NS procedures, lymph node yield, SM status, and LOS. Conversely, operation time was shorter in ORP, and blood loss, transfusion rates and time to catheter removal were significantly lower in RARP. CONCLUSIONS: Both surgical approaches, performed in a high-volume centre by the same surgeons, achieve excellent, comparable oncological and functional outcomes. However, a modest advantage for RARP for surgical outcomes was observed, most likely attributable to its minimally invasive nature, and better teaching capabilities. Consequently, more than the surgical approach itself, the well-trained surgeon remains the most important factor to achieve satisfactory outcomes.

Perioperative management of direct oral anticoagulants in patients undergoing radical prostatectomy: results of a prospective assessment.

INTRODUCTION AND OBJECTIVES: In the perioperative setting, temporary interruption of direct oral anticoagulants (DOACs) is recommended. However, the safety of these recommendations is based on non-urological surgical experiences. Our objective was to verify the safety of these recommendations in patients undergoing radical prostatectomy (RP). MATERIALS AND METHODS: Patients regularly receiving a DOAC and scheduled for RP at our institution were prospectively assessed. DOAC intake was usually stopped 48 h before surgery without any preoperative bridging therapy. Postoperatively, patients received risk-adapted low-molecular weight heparin (LMWH). On the third day after unremarkable RP, DOAC intake was restarted and the administration of LMWH was stopped. We assessed perioperative outcomes and 30-day morbidity. RESULTS: Thirty-two consecutive patients receiving DOAC underwent RP at our institution between 12/2017 and 07/2018. Time of surgery (median, 177 min) and intraoperative blood loss (median, 500 mL) were unremarkable. DOACs were restarted on the third postoperative day in 30 patients (94%). No patient had a significant hemoglobin level reduction after DOAC restart. Overall, 28% of patients experienced complications within 30 days after surgery. Most of which were minor (Clavien ≤ 2), three patients (9%), however, had Clavien ≥ 3 complications. CONCLUSION: Our report is the first to prospectively assess current guideline recommendations regarding DOAC restarting after major urological surgery. RP can safely be performed, if DOACs are correctly paused before surgery. Moreover, in case of an uneventful postoperative clinical course, DOACs can be safely restarted on the third postoperative day. A 9% Clavien ≥ 3 30-day morbidity warrants attention and should be further explored in future studies.

Postoperative complications of contemporary open and robot-assisted laparoscopic radical prostatectomy using standardised reporting systems.

OBJECTIVES: To analyse time trends and contemporary rates of postoperative complications after radical prostatectomy (RP) and to compare the complication profile of open RP (ORP) and robot-assisted laparoscopic RP (RALP) using standardised reporting systems. PATIENTS AND METHODS: Retrospective analysis of 13 924 RP patients in a single institution (2005-2015). Complications were collected during hospital stay and via standardised questionnaire 3 months after, and grouped into eight schemes. Since 2013, the revised Clavien-Dindo classification was used (n = 4 379). Annual incidence rates of different complications were graphically displayed. Multivariable logistic regression analyses compared complications between ORP and RALP after inverse probability of treatment weighting (IPTW). RESULTS: After the introduction of standardised classification systems, complication rates have increased with a contemporary rate of 20.6% (2013-2015). While minor Clavien-Dindo grades represented the majority (I: 10.6%; II: 7.9%), severe complications (Grades IV-V) were rare (<1%). In logistic regression analyses after IPTW, RALP was associated with less blood loss, shorter catheterisation time, and lower risk of Clavien-Dindo Grade II and III complications. CONCLUSION: Our results emphasise the importance of standardised reporting systems for quality control and comparison across approaches or institutions. Contemporary complication rates in a high-volume centre remain low and are most frequently minor Clavien-Dindo grades. RALP had a slightly better complication profile compared to ORP.

Salvage radical prostatectomy for recurrent prostate cancer: verification of European Association of Urology guideline criteria.

OBJECTIVE: To analyse oncological and functional outcomes of salvage radical prostatectomy (SRP) in patients with recurrent prostate cancer and to compare outcomes of patients within and outside the European Association of Urology (EAU) guideline criteria (organ-confined prostate cancer ≤T2b, Gleason score ≤7 and preoperative PSA level <10 ng/mL) for SRP. PATIENTS AND METHODS: In all, 55 patients who underwent SRP from January 2007 to December 2012 were retrospectively analysed. Kaplan-Meier curves assessed time to biochemical recurrence (BCR), metastasis-free survival (MFS) and cancer-specific survival. Cox regressions addressed factors influencing BCR and MFS. BCR was defined as a PSA level of >0.2 ng/mL and rising, continence as the use of 0-1 safety pad/day, and potency as a five-item version of the International Index of Erectile Function score of ≥18. RESULTS: The median follow-up was 36 months. After SRP, 42.0% of the patients experienced BCR, 15.9% developed metastasis, and 5.5% died from prostate cancer. Patients fulfilling the EAU guideline criteria were less likely to have positive lymph nodes (LNs) and had significantly better BCR-free survival (5-year BCR-free survival 73.9% vs 11.6%; P = 0.001). In multivariate analysis, low-dose-rate brachytherapy as primary treatment (P = 0.03) and presence of positive LNs at SRP (P = 0.02) were significantly associated with worse BCR-free survival. The presence of positive LNs or Gleason score >7 at SRP were independently associated with metastasis. The urinary continence rate at 1 year after SRP was 74%. Seven patients (12.7%) had complications ≥III (Clavien grade). CONCLUSION: SRP is a safe procedure providing good cancer control and reasonable urinary continence. Oncological outcomes are significantly better in patients who met the EAU guideline recommendations.

Additional elastography-targeted biopsy improves the agreement between biopsy Gleason grade and Gleason grade at radical prostatectomy.

PURPOSE: To assess whether real-time elastography-targeted biopsy (RTE-bx) may help to correctly assign Gleason grade at radical prostatectomy (RP) and to compare discriminant properties of systematic biopsy alone (sbx) versus combination with RTE-bx (comb-bx) to distinguish between postoperatively favorable (Gleason 3 + 3, pT2, Nx/0) and postoperatively unfavorable (Gleason ≥4 + 4) prostate cancer (PCa) at RP. PATIENTS AND METHODS: Overall, 259 patients diagnosed with PCa at systematic biopsy in combination with RTE-bx underwent RP between 2008 and 2011. Gleason Score derived from sbx versus comb-bx was compared to the gold-standard RP, and discriminant properties were assessed. Specificity gains were examined for sbx versus comb-bx when the endpoint consisted of postoperatively favorable PCa at RP. Sensitivity gains were examined, when analyses focused on postoperatively unfavorable PCa. RESULTS: Comb-bx resulted in higher correct overall Gleason assignment (68.3 vs. 56.7 %, p = 0.008) than sbx. Similarly, lower rates of undergrading (21.2 vs. 36.3 %, p < 0.001) were recorded. Specificity gains with comb-bx were 10 % (92 vs. 82 %, p = 0.004) for postoperatively favorable PCa. Comb-bx resulted in 31 % sensitivity gains relative to sbx (94 vs. 63 %, p = 0.03), when postoperatively unfavorable PCa was the endpoint. CONCLUSION: The agreement between biopsy and pathology Gleason Score was significantly higher for comb-bx than sbx. Additionally, comb-bx reduced the rate of false positives in the diagnosis of favorable PCa. Rates of correctly classified unfavorable PCa at RP were also higher for comb-bx. Those data indicate that comb-bx is useful in clinical practice.

Oncological, functional and perioperative outcomes in transplant patients after radical prostatectomy.

PURPOSE: Oncological surgery in immunosuppressed patients with solid organ transplantation (Tx) is challenging. These patients are thought to have higher postoperative morbidity and an increased rate of tumour progression. The aim of the present study was to analyse oncological, functional and perioperative outcomes in Tx patients following radical prostatectomy (RP). MATERIALS AND METHODS: Between 1996 and 2014, 30 patients diagnosed with prostate cancer underwent RP at our institution following Tx (kidney: n = 20, heart: n = 5, liver: n = 5). Functional, oncological and perioperative follow-ups were analysed. Postoperative complications were assessed using the Clavien-Dindo classification. RESULTS: Median follow-up was 45 months. Median PSA was 5.3 ng/ml. Intraoperative blood loss was 600 ml at a median operating time of 180 min. Surgery in kidney Tx patients was technically feasible. Major complications occurred in 3 patients (ureteral injury, lymphocele and haematoma). Histological evaluation revealed n = 18 ≤pT2 tumours (60.0 %), n = 7 pT3a tumours (23.3 %) and n = 5 ≥pT3b tumours (16.7 %). Continence rate 12 months after surgery, defined as no or one safety pad use, was 73.3 %, while 93.3 % of the patients used ≤2 pads/24 h. After the median follow-up of 45 months, BCR-free survival was 69.0 %. In recurrent men, there was suspicion of metastasis in one patient. No cancer-specific death was observed. Five-year overall survival was 94.4 %. CONCLUSION: The complication rate in patients with solid organ transplantation after RP was low. While histopathological evaluation revealed disease characteristics comparable to non-transplant patients from current RP series, postoperative continence was worse. Immunosuppressive therapy does not seem to lead to an increased rate of tumour progression.

Differences in Patient Characteristics Among Men Choosing Open or Robot-Assisted Radical Prostatectomy in Contemporary Practice at a European High-Volume Center.

OBJECTIVE: To examine the characteristics of robot-assisted radical prostatectomy (RARP) and open radical prostatectomy (ORP) patients at a high-volume center. PATIENTS AND METHODS: We relied on the Martini-Clinic database and focused on prostate cancer patients treated in 2013. Characteristics in ORP and RARP patients were assessed. In multivariable logistic regression analyses (MVA), we predicted RARP treatment. RESULTS: Of 1,920 patients, 575 (29.9%) underwent RARP and 1,345 (70.1%) ORP. RARP patients had a lower prostate-specific antigen (PSA), and were less likely to harbor pT3b, pathological Gleason ≥4 + 4 or lymph node metastases (all p < 0.05). Pelvic lymph node dissection (PLND) (84.3 vs. 87.0%, p = 0.1), as well as positive surgical margins (15.5 vs. 15.7%, p = 0.7) and the nerve-sparing status (p = 0.5) were comparable between RARP and ORP. Lymph node yield (median 11 vs. 16), and median blood loss (250 vs. 700 ml) were lower at RARP (all p < 0.001). Additionally, the median operating room time was higher at RARP (215 vs. 185 min, p < 0.001). In MVA, patients with body mass index (BMI) ≥30 were more likely to undergo RARP (OR 1.8, 95% CI 1.3-2.4, p < 0.001). Conversely, patients with PSA >20 ng/ml were less likely to undergo RARP (OR 0.6, 95% CI 0.4-1.0, p = 0.03). CONCLUSIONS: More favorable pathological characteristics were recorded at RARP. High BMI and low PSA were independent predictors for RARP. Treatment characteristics such as PLND rates, margin status and nerve sparing were comparable between RARP and ORP. Despite lower blood loss at RARP, a longer operating room time and lower yield of lymph nodes were recorded.

Concurrent deletion of 16q23 and PTEN is an independent prognostic feature in prostate cancer.

The deletion of 16q23-q24 belongs to the most frequent chromosomal changes in prostate cancer, but the clinical consequences of this alteration have not been studied in detail. We performed fluorescence in situ hybridization analysis using a 16q23 probe in more than 7,400 prostate cancers with clinical follow-up data assembled in a tissue microarray format. Chromosome 16q deletion was found in 21% of cancers, and was linked to advanced tumor stage, high Gleason grade, accelerated cell proliferation, the presence of lymph node metastases (p < 0.0001 each) and positive surgical margin (p = 0.0004). 16q Deletion was more frequent in ERG fusion-positive (27%) as compared to ERG fusion-negative cancers (16%, p < 0.0001), and was linked to other ERG-associated deletions including phosphatase and tensin homolog (PTEN) (p < 0.0001) and 3p13 (p = 0.0303). In univariate analysis, the deletion of 16q was linked to early biochemical recurrence independently from the ERG status (p < 0.0001). Tumors with codeletions of 16q and PTEN had a worse prognosis (p = 0.0199) than those with PTEN or the deletion of 16q alone. Multivariate modeling revealed that the prognostic value of 16q/PTEN deletion patterns was independent from the established prognostic factors. In summary, the results of our study demonstrate that the deletion of 16q and PTEN cooperatively drives prostate cancer progression, and suggests that deletion analysis of 16q and PTEN could be of important clinical value particularly for preoperative risk assessment of the clinically most challenging group of low- and intermediated grade prostate cancers.

Impact of prostate volume on oncologic, perioperative, and functional outcomes after radical prostatectomy.

BACKGROUND: The impact of prostate volume (PV) on oncologic, perioperative and functional outcomes after radical prostatectomy (RP) remains controversial, as recent studies present inconsistent results. We studied the influence of PV on outcomes in a large single center dataset and summarized the existing literature. METHODS: 5,477 patients who underwent RP between January 2008 and December 2011 were analyzed. The impact of PV on biochemical recurrence (BCR) and metastasis-free survival (MFS) was assessed using Kaplan-Meier curves and multivariate Cox proportional hazard model. Uni- and multivariate logistic regressions were used to estimate the impact of PV on surgical margin (SM), 1-week, 3-months and 12-months continence and 3-months and 12-months potency. Finally, the impact of PV on intraoperative blood loss was analyzed using uni- and multivariate linear regressions. RESULTS: Median follow-up was 36.1 months. Overall, 16.5% of patients recurred during the follow-up period. The mean preoperative PV was 43.3 ml. One-week, 3-months and 12-months continence rates were 55.6%, 69.3%, and 87.4% for patients with PV ≥ 70 compared to 64.4%, 78.3%, and 92.1% for patients with PV < 30, respectively. Three-months and 12-months potency rates were 37.1% and 54.8% for men with large glands (≥70) and 56.3% and 65.0% for men with PV < 30. In multivariate analysis, continence at 1 week, 3 months and 12 months was significantly worse in patients with glands ≥70 ml, while potency was not influenced by PV in multivariate analysis. There was a higher mean blood loss (P < 0.001) in patients with larger glands. In univariate analysis, higher PV was significantly associated with lower BCR (P = 0.019), but not with metastasis free survival (P = 0.112). CONCLUSIONS: PV significantly influences BCR-free survival only in univariate analysis. Especially early (1-week and 3-months) postoperative continence is negatively affected by higher PV in multivariate analysis, while PV did not influence potency after adjusting for further covariates in a specialized high-volume institution.

Use of phosphodiesterase type 5 inhibitors may adversely impact biochemical recurrence after radical prostatectomy.

PURPOSE: Experimental evidence suggests that phosphodiesterase type 5 inhibitors may suppress tumor growth, postpone metastasis and prolong survival, but clinical data are lacking. We studied the effect of phosphodiesterase type 5 inhibitors on biochemical recurrence after radical prostatectomy for prostate cancer. MATERIALS AND METHODS: The study was comprised of 4,752 consecutive patients with localized prostate cancer treated with bilateral nerve sparing radical prostatectomy between January 2000 and December 2010. Of these patients 1,110 (23.4%) received phosphodiesterase type 5 inhibitors postoperatively while 3,642 (76.6%) did not. The risk of biochemical recurrence was compared between the phosphodiesterase type 5 inhibitor group and the nonphosphodiesterase type 5 inhibitor group. Cox multivariate proportional hazard models and confidence intervals were used to estimate the hazard ratio of biochemical recurrence associated with phosphodiesterase type 5 inhibitor use. Propensity score matched analysis was performed. RESULTS: Median followup was 60.3 months (IQR 36.7-84.5). Five-year biochemical recurrence-free survival estimates in the phosphodiesterase type 5 inhibitor vs nonphosphodiesterase type 5 inhibitor groups were 84.7% (95% CI 82.1-87.0) and 89.2% (95% CI 88.1-90.3), respectively (p=0.0006). Multivariate regression analysis showed that phosphodiesterase type 5 inhibitor use was an independent risk factor for biochemical recurrence (HR 1.38, 95% CI 1.11-1.70, p=0.0035) and this was also true after propensity score matching. CONCLUSIONS: Contrary to experimental data, the use of phosphodiesterase type 5 inhibitors after radical prostatectomy may adversely impact biochemical recurrence. Further studies are needed to validate our results.

Effect of surgical approach on erectile function recovery following bilateral nerve-sparing radical prostatectomy: an evaluation utilising data from a randomised, double-blind, double-dummy multicentre trial of tadalafil vs placebo.

OBJECTIVES: To report pre-specified and exploratory results on the effect of different surgical approaches on erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) obtained from the multicentre, randomised, double-blind, double-dummy REACTT trial of tadalafil (once a day [OaD] or on-demand [pro-re-nata, PRN]) vs placebo. PATIENTS AND METHODS: Patients aged <68 years with normal preoperative EF who underwent nsRP for localised prostate cancer (Gleason ≤7, prostate-specific antigen [PSA] <10 ng/mL) were randomised after nsRP 1:1:1 to 9-month double-blind treatment with tadalafil 5 mg OaD, tadalafil 20 mg PRN, or placebo, followed by 6-week drug-free washout, and 3-month open-label OaD treatment (all patients). Recovery of EF was defined as an International Index of Erectile Function (IIEF)-EF domain score of ≥22 and normal orgasmic function was defined based on IIEF Question 10. Both parameters were analysed at the end of washout using logistic regression including terms for treatment, country, visit, visit-by-treatment interaction, age group, nerve-sparing score (perfect = 2, non-perfect >2), and surgical approach (open surgery, robot-assisted laparoscopy, conventional laparoscopy, other). Time to EF recovery was analysed post hoc with a Cox proportional-hazards model including terms for treatment, age-group, country, surgical approach and surgery-by-treatment interaction. RESULTS: Of 422 patients treated, 189 underwent open surgery, 115 robot-assisted laparoscopy, 88 conventional laparoscopy and 30 surgery classified as 'other'. The odds of achieving EF recovery at the end of drug-free washout were about twice as high for the robot-assisted laparoscopy group compared with the open surgery group (odds ratio 2.42; 95% confidence interval [CI] 1.24, 4.72; P = 0.029). Patients who underwent robot-assisted laparoscopy were significantly more likely to recover during double-blind treatment compared with patients who underwent open surgery (hazard ratio 1.92; 95% CI 1.17, 3.15; P = 0.010). No favourable effect of conventional laparoscopy compared with open surgery could be seen. CONCLUSION: These results may provide further insights into the role of surgery on EF recovery after nsRP. However, the trial was not designed for these analyses and further prospective studies are needed.

Safe-R: a novel score, accounting for oncological safe nerve-sparing at radical prostatectomy for localized prostate cancer.

OBJECTIVES: The objectives of the study were to describe a novel score (safe-R), combining information on surgical margin status (SM) and extend of nerve-sparing (NS) applicable for all patients undergoing radical prostatectomy (RP), and to test the impact of our frozen-section navigated nerve-sparing approach (NeuroSAFE) on safe-R score. METHODS: We retrospectively analyzed 9,635 RPs performed at our center between 2002 and 2011. Of these, 47 % were conducted with NeuroSAFE. Proportions of NS and SM status were assessed. Subsequently, a score for oncological safe NS (safe-R) was developed; Safe-R was categorized as 3 (for negative SM and bilateral NS), 2 (for negative SM and unilateral NS), 1 (for negative SM without NS), and 0 (for patients with positive SM), respectively. The impact of NeuroSAFE on safe-R was analyzed by chi-square test and confirmed by multinomial logistic regression, adjusting for preoperative risk factors. RESULTS: Applying NeuroSAFE resulted in enhanced safe-R score, indicating lower rates of positive SM and higher rates of NS, across all risk categories (all p < 0.001). For example in high-risk patients, NeuroSAFE resulted in lower proportions of safe-R 0 (27.6 vs. 33.6 %) and higher proportions of safe-R 3 (32.4 vs. 17.1 %, p < 0.001). Linkage between the NeuroSAFE approach and safe-R was confirmed after multinomial logistic adjustment for preoperative risk factors. All results were confirmed in a propensity-matched cohort (matched for preoperative risk factors and year of surgery, data not shown). CONCLUSION: Safe-R represents a novel tool to assess and report on oncological safe nerve-sparing in RP. NeuroSAFE is associated with enhanced safe-R scores.

A tertiary Gleason pattern in the prostatectomy specimen and its association with adverse outcome after radical prostatectomy.

PURPOSE: The prognostic significance of a tertiary Gleason pattern in the radical prostatectomy specimen is controversial. We tested the impact of a tertiary Gleason pattern on adverse histopathological features and biochemical recurrence rates after radical prostatectomy. MATERIALS AND METHODS: We assessed data on 11,226 consecutive patients treated with radical prostatectomy at our institution between June 2007 and February 2013. We compared 2,396 patients with (22.4%) and 8,260 without (77.5%) a tertiary Gleason pattern for adverse histopathological features (extraprostatic extension, seminal vesicle invasion, positive surgical margins and lymph node invasion) using the chi-square test. The effect of a tertiary Gleason pattern on biochemical recurrence was tested in univariable and multivariable models. Subanalyses were then done for different radical prostatectomy Gleason groups (6 or less, 3 + 4 and 4 + 3). RESULTS: A tertiary Gleason pattern was statistically significantly associated with all evaluated histopathological parameters (each p <0.001). It was an independent predictor of biochemical recurrence (HR 1.43, p <0.001). On subanalysis only a tertiary Gleason pattern independently predicted biochemical recurrence in the patient cohort with a radical prostatectomy Gleason score of 3 + 4 and 4 + 3. However, it failed to attain independent predictor status in patients with a radical prostatectomy Gleason score of 6 or less. CONCLUSIONS: A tertiary Gleason pattern is a significant and independent predictor of biochemical recurrence after radical prostatectomy with the strongest prognostic effect in cases with Gleason scores 3 + 4 and 4 + 3. Therefore, a tertiary Gleason pattern should be recorded in the pathological report.