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Background: Evidence-practice gaps exist in urology. We previously surveyed European Association of Urology (EAU) guidelines for strong recommendations underpinned by high-certainty evidence that impact patient experience for which practice variations were suspected. The recommendation “Do not offer neoadjuvant androgen deprivation therapy (ADT) before surgery for patients with prostate cancer” was prioritised for further investigation. ADT before surgery is neither clinically effective nor cost effective and has serious side effects. The first step in improving implementation problems is to understand their extent. A clear picture of practice regarding ADT before surgery across Europe is not available. Objective: To assess current ADT use before prostate cancer surgery in Europe. Design, setting, and participants: This was an observational cross-sectional study. We retrospectively audited recent ADT practices in a multicentre international setting. We used nonprobability purposive sampling, aiming for breadth in terms of low- versus high-volume, academic, versus community and public versus private centres. Outcome measurements and statistical analysis: Our primary outcome was adherence to the ADT recommendation. Descriptive statistics and a multilevel model were used to investigate differences between countries across different factors (volume, centre type, and funding type). Subgroup analyses were performed for patients with low, intermediate, and high risk, and for those with locally advanced prostate cancer. We also collected reasons for nonadherence. Results and limitations: We included 6598 patients with prostate cancer from 187 hospitals in 31 countries from January 1, 2017 to May 1, 2020. Overall, nonadherence was 2%, (range 0–32%). Most of the variability was found in the high-risk subgroup, for which nonadherence was 4% (range 0–43%). Reasons for nonadherence included attempts to improve oncological outcomes or preoperative tumour parameters; attempts to control the cancer because of long waiting lists; and patient preference (changing one's mind from radiotherapy to surgery after neoadjuvant ADT had commenced or feeling that the side effects were intolerable). Although we purposively sampled for variety within countries (public/private, academic/community, high/low-volume), a selection bias toward centres with awareness of guidelines is possible, so adherence rates may be overestimated. Conclusions: EAU guidelines recommend against ADT use before prostate cancer surgery, yet some guideline-discordant ADT use remains at the cost of patient experience and an additional payer and provider burden. Strategies towards discontinuation of inappropriate preoperative ADT use should be pursued. Patient summary: Androgen deprivation therapy (ADT) is sometimes used in men with prostate cancer who will not benefit from it. ADT causes side effects such as weight gain and emotional changes and increases the risk of cardiovascular disease, diabetes, and osteoporosis. Guidelines strongly recommend that men opting for surgery should not receive ADT, but it is unclear how well the guidance is followed. We asked urologists across Europe how patients in their institutions were treated over the past few years. Most do not use ADT before surgery, but this still happens in some places. More research is needed to help doctors to stop using ADT in patients who will not benefit from it.

CoreTherm (ProstaLund AB, Lund, Sweden) is an outpatient treatment option in men with lower urinary tract symptoms and catheter-dependent men with chronic urinary retention caused by benign prostatic obstruction (BPO). CoreTherm is high-energy transurethral microwave thermotherapy with feedback technique. Modern treatment with CoreTherm includes transurethral intraprostatic injections of mepivacaine and adrenalineThe aim of this study was to evaluate the short- and long-term retreatment risk in men with large prostates and BPO or chronic urinary retention, all primarily treated with CoreTherm.All men from the same geographical area with prostate volumes ≥ 80 ml treated 1999-2015 with CoreTherm and having BPO or were catheter-dependent due to chronic urinary retention, were included. End of study period was defined as December 31, 2019.We identified and evaluated 570 men treated with CoreTherm, where 12% (71 patients) were surgically retreated during the follow-up. Mean follow-up was 11 years, and maximum follow-up was 20 years. The long-term retreatment rate in our study was 23%. A majority of these could be retreated with CoreTherm or TURP, with only 3% requiring open surgery.We conclude that CoreTherm is a suitable outpatient treatment option in patients with profoundly enlarged prostates, regardless of age, prostate size, and reason for treatment.

BACKGROUND: Differences in outcome after radical prostatectomy for prostate cancer can partly be explained by inter-surgeon differences, where degree of experience is one important aspect. OBJECTIVE: To define the learning curve of robot-assisted laparoscopic prostatectomy regarding oncological and functional outcomes. MATERIALS AND METHODS: Out of 4003 enrolled patients in the LAPPRO trial, 3583 met the inclusion criteria, of which 885 were operated by open technique. A total of 2672 patients with clinically localized prostate cancer from seven Swedish centers were operated by robot-assisted laparoscopic and followed for eight years (LAPPRO trial). Oncological outcomes were pathology reported surgical margin and biochemical recurrence at eight years. Functional outcomes included patient-reported urinary incontinence and erectile dysfunction at 3, 12 and 24 months. Experience was surgeon-reported experience prior to and within the study. The relationship between surgeon experience and functional outcomes and surgical margin status was analysed by mixed effect logistic regression. Biochemical recurrence was analysed by Cox regression with robust standard errors. RESULTS: The learning curve for positive surgical margin was relatively flat with a rate of 21% for surgeons between 0–74 cases and 24% for surgeons who had performed >300 cases. Biochemical recurrence at 4 years was 11% (0–74 cases) and 13% (>300 cases). Incontinence was stable over the learning curve but erectile function improved (at 2 years from 38% (0–74 cases) to 53% (>300 cases)). CONCLUSIONS: Analysis of the learning curve for surgeons performing robot assisted laparoscopic prostatectomy showed erectile function improved with increasing number of procedures which was not the case for the oncological outcomes.

BACKGROUND: Screening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown. METHODS: We invited 37,887 men who were 50 to 60 years of age to undergo regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter or higher underwent magnetic resonance imaging (MRI) of the prostate; one third of the participants were randomly assigned to a reference group that underwent systematic biopsy as well as targeted biopsy of suspicious lesions shown on MRI. The remaining participants were assigned to the experimental group and underwent MRI-targeted biopsy only. The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically significant prostate cancer, defined as a Gleason score of at least 3+4. Safety was also assessed. RESULTS: Of the men who were invited to undergo screening, 17,980 (47%) participated in the trial. A total of 66 of the 11,986 participants in the experimental group (0.6%) received a diagnosis of clinically insignificant prostate cancer, as compared with 72 of 5994 participants (1.2%) in the reference group, a difference of −0.7 percentage points (95% confidence interval [CI], −1.0 to −0.4; relative risk, 0.46; 95% CI, 0.33 to 0.64; P

We evaluated long-term risk for biochemical recurrence and subsequent prognosis in a population-based cohort.We used register-based data to evaluate 6 675 consecutive patients having radical prostatectomy in Västra Götaland county in Sweden during 1995-2014. Patients were followed until death or end of study, 31 December 2014. Data were collected from registers on national, regional and local level and linked by means of the Swedish personal identity number. Biochemical recurrence was defined as PSA ≥0.2 ng/ml; failure as hormonal treatment, metastasis or prostate cancer death. Survival analysis was used to estimate time to biochemical recurrence and time to failure after biochemical recurrence for patients with 0 - 2 years, 2-5 years, 5-10 years and10 years interval to biochemical recurrence, respectively.A total of 1214 men had biochemical recurrence during follow-up. Biochemical recurrence-free survival was 83% (95% confidence interval [CI] 82-84%), 75% (95% CI 74-77%) and 69% (95% CI 67-71%) at 5, 10 and 15 years, respectively. Cumulative incidence of failure for all patients 15 years after biochemical recurrence was 50% (95% CI 43-55%) in competing risk analysis. The risk of failure after biochemical recurrence was highest among patients having biochemical recurrence within 2 years from surgery. Incomplete data on PSA-history is a limitation.The risk for biochemical recurrence persists 15 years after surgery. Follow-up should continue as long as treatment would be considered in case of recurrent disease.

Background Reports on possible benefits for continence with nerve-sparing (NS) radical prostatectomy have expanded the indications beyond preservation of erectile function. It is unclear whether NS surgery affects oncological outcomes. Objective To determine whether the degree of NS during radical prostatectomy influences oncological outcomes. Design, setting, and participants Of 4003 patients enrolled in a prospective, controlled trial comparing open and robotic radical prostatectomy during 2008–2011, we evaluated 2401 patients who received robotic radical prostatectomy at seven Swedish centres. Patients were followed for 8 yr. Outcome measurements and statistical analysis Data for recurrence and positive surgical margin status were assessed using validated patient questionnaires, patient interviews, and clinical record forms before and at 3, 12, and 24 mo and 6 and 8 yr after surgery. Cox and logistic regressions were used to model the effect on recurrence and positive surgical margins (PSM), respectively. Results and limitations A total of 481 men had PSM and 467 experienced recurrence during follow-up. Median follow-up for men without recurrence was 6.6 yr. There were no statistically significant differences in recurrence rate between degrees of NS. The PSM rate was significantly higher with a higher degree of NS: interfascial NS, odds ratio (OR) 2.32 (95% confidence interval [CI] 1.69–3.16); intrafascial NS, OR 3.23 (95% CI 2.17–4.80). Recurrence rates were higher for patients with pT2 disease and PSM (hazard ratio [HR] 3.32, 95% CI 2.43–4.53) than for patients with pT3 disease without PSM (HR 2.08, 95% CI 1.66–2.62). The lack of central review of pathological specimens is a limitation. Conclusions A higher degree of NS significantly increased the risk of PSM but did not significantly increase the risk of cancer recurrence. Combined with the known functional benefits of NS surgery, these results underscore the need to identify an individualised balance. Patient summary In this report we looked at the effect of a nerve-sparing approach during removal of the prostate on cancer outcomes for patients having robot-assisted surgery at seven Swedish hospitals. We found that a high degree of nerve-sparing increased the rate of cancer positivity at the margins of surgical specimens and that positive surgical margins increased the risk of recurrence of prostate cancer., Take Home Message Nerve-sparing radical prostatectomy increases the rate of positive surgical margins. Although no direct effect on recurrence is evident, this is important to address in mutual decision-making with the patient.

Objective: There is now an unprecedented amount of evidence to consider when revising prostate cancer guidelines. We believe that there is a value in publishing summaries of national clinical guidelines in English for others to read and comment on. Methods: This is part 1 of a summary of the Swedish prostate cancer guidelines that were published in June 2022. It covers the early detection, diagnostics, staging, patient support and management of the non-metastatic disease. Part 2 covers recurrence after local treatment and management of the metastatic disease. Results: The 2022 Swedish guidelines include several new recommendations: rectal iodine-povidone to reduce post-biopsy infections, external beam radiation with focal boost to the tumour, use of a pre-rectal spacer to reduce rectal side effects after external beam radiotherapy in some expert centres, 6 months’ concomitant and adjuvant rather than neoadjuvant and concomitant hormonal treatment together with radiotherapy for unfavourable intermediate and high-risk disease, and adjuvant abiraterone plus prednisolone together with a GnRH agonist for a subgroup of men with very high-risk disease. The Swedish guidelines differ from the European by having more restrictive recommendations regarding genetic testing and pelvic lymph node dissection, the risk group classification, recommending ultra-hypofractionated (7 fractions) external radiotherapy for intermediate and selected high-risk cancers, by not recommending any hormonal treatment together with radiotherapy for favourable intermediate-risk disease, and by recommending bicalutamide monotherapy instead of a GnRH agonist for some patient groups. Conclusions: The 2022 Swedish prostate cancer guidelines include several new recommendations and some that differ from the European guidelines.

Objective: There is now an unprecedented amount of evidence to consider when revising prostate cancer guidelines. We believe that there is a value in publishing summaries of national clinical guidelines in English for others to read and comment on. Methods: This is part 2 of a summary of the Swedish prostate cancer guidelines that were published in June 2022. This part covers recurrence after local treatment and management of metastatic and castration resistant disease. Part 1 covers early detection, diagnostics, staging, patient support and management of non-metastatic disease. Results: The 2022 Swedish guidelines include several new recommendations. Among these is a recommendation of a period of observation with repeated PSA tests for patients with approximately 10 years’ life expectancy who experience a BCR more than 2–5 years after radical prostatectomy, to allow for estimating the PSA doubling time before deciding whether to give salvage radiotherapy or not. Recent results from the PEACE-1 trial led to the recommendation of triple-treatment with a GnRH agonist, abiraterone plus prednisolone and 6 cycles of docetaxel for patients with high-volume metastatic disease who are fit for chemotherapy. The Swedish guidelines differ from the European ones by having more restrictive recommendations about genetic testing of and high-dose zoledronic acid or denosumab treatment for men with metastatic prostate cancer, and by recommending considering bicalutamide monotherapy for selected patients with low-volume metastatic disease. Conclusions: The 2022 Swedish prostate cancer guidelines include several new recommendations and some that differ from the European guidelines.

To evaluate urinary continence (UC) recovery and oncological outcomes in different risk-groups after robot-assisted radical prostatectomy (RALP) and open retropubic radical prostatectomy (RRP). We analysed 2650 men with prostate cancer from seven open (n = 805) and seven robotic (n = 1845) Swedish centres between 2008 and 2011 in a prospective non-randomised trial, LAPPRO. UC recovery was defined as change of pads less than once in 24 h. Information was collected through validated questionnaires. Rate of positive surgical margins (PSM) and biochemical recurrence (BCR), defined as prostate-specific antigen (PSA) > 0.25 mg/ml, were recorded. We stratified patients into two risk groups (low-intermediate and high risk) based on the D’Amico risk classification system. Among men with high-risk prostate cancer, we found significantly higher rates of UC recovery up to 24 months after RRP compared to RALP (66.1% vs 60.5%) RR 0.85 (CI 95% 0.73–0.99) while PSM was more frequent after RRP compared to RALP (46.8% vs 23.5%) RR 1.56 (CI 95% 1.10–2.21). In the same group no significant difference was seen in BCR. Overall, however, BCR was significantly more common after RRP compared to RALP at 24 months (9.8% vs 6.6%) RR 1.43 (Cl 95% 1.08–1.89). The limitations of this study are its non-randomized design and the relatively short time of follow-up. Our study indicates that men with high-risk tumour operated with open surgery had better urinary continence recovery but with a higher risk of PSM than after robotic-assisted laparoscopic surgery. No significant difference was seen in biochemical recurrence. ISRCTN06393679.

Objective To describe the study design of the GOTEBORG prostate cancer screening (PC) 2 (Goteborg-2), a prospective, randomised, population-based trial of PC screening. This trial evaluates whether prostate-specific antigen (PSA) testing followed by 3 Tesla prostate magnetic resonance imaging (MRI) and targeted biopsy can reduce overdiagnosis, while maintaining the detection of clinically significant cancer, compared to PSA-screening and systematic biopsy. Materials and methods A random sample of men 50-60 years in the Goteborg area, Sweden, identified from the Total Population Register, were randomised to either a screening or control group (CG). Participants in the screening group (SG) were further randomised into one of three arms: (1) PSA-test; if PSA ≥ 3 ng/mL, then MRI and systematic biopsy, plus targeted biopsy to suspicious lesions as per Prostate Imaging - Reporting and Data System, version 2 (PI-RADSv2) 3-5; (2) PSA-test; if PSA ≥ 3 ng/mL, then MRI, and targeted biopsy only if PI-RADSv2 3-5; (3) identical to Arm 2, except lower PSA-cut-off ≥1.8 ng/mL. The primary outcome is the detection rate of clinically insignificant PC (defined as Gleason Score 3 + 3 [Grade Group 1]) comparing all men with PSA ≥ 3 ng/mL in Arm 1 vs. Arm 2 + 3. Results Randomisation and enrolment started in September 2015. Accrual has hitherto resulted in 38,770 men randomised to the SG. The participation rate is 50%. Invitation to the first screening round was completed in June 2020. Conclusions The Goteborg-2 trial will provide new knowledge about the performance of prostate MRI in a screening setting.

Our goal was to analyze results from 22 years of followup in the Göteborg randomized prostate cancer (PC) screening trial.In December 1994, 20,000 men born 1930-1944 were randomly extracted from the Swedish population register and were randomized (1:1) into either a screening group (SG) or to a control group (CG). Men in the SG were repeatedly invited for biennial prostate specific antigen testing up to an average age of 69 years. Main endpoints were PC incidence and mortality (intention-to-screen principle).After 22 years, 1,528 men in the SG and 1,124 men in the CG had been diagnosed with PC. In total, 112 PC deaths occurred in the SG and 158 in the CG. Compared with the CG, the SG showed a PC incidence rate ratio (RR) of 1.42 (95% CI, 1.31-1.53) and a PC mortality RR of 0.71 (95% CI, 0.55-0.91). The 22-year cumulative PC mortality rate was 1.55% (95% CI, 1.29-1.86) in the SG and 2.13% (95% CI, 1.83-2.49) in the CG. Correction for nonattendance (Cuzick method) yielded a RR of PC mortality of 0.59 (95% CI, 0.43-0.80). Number needed to invite and number needed to diagnose was estimated to 221 and 9, respectively. PC death risk was increased in the following groups: nontesting men, men entering the program after age 60 and men with10 years of followup after screening termination.Prostate specific antigen-based screening substantially decreases PC mortality. However, not attending, starting after age 60 and stopping at age 70 seem to be major pitfalls regarding PC death risk.

Objectives: To evaluate how surgeon heterogeneity – the variation in outcomes between individual surgeons – influences functional and oncological outcomes after robot-assisted laparoscopic prostatectomy (RALP) and retropubic radical prostatectomy (RRP), and to assess whether surgeon heterogeneity affects the comparison between RALP and RRP. Patients and Methods: Laparoscopic Prostatectomy Robot Open (LAPPRO) is a prospective, controlled, non-randomized trial performed at 14 Swedish centres with 68 operating surgeons. A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011. The endpoints were urinary incontinence, erectile dysfunction (ED) and recurrence at 24 months after surgery. Logistic regression models were built to evaluate surgeon heterogeneity and, secondarily, surgeon-specific factors were added to the models to investigate their influence on heterogeneity and the comparison between RALP and RRP. Results: Among surgeons who performed at least 20 surgeries during the study period (n=25), we observed statistically significant heterogeneity for incontinence (P = 0.001), ED (P < 0.001) and rate of recurrent disease (P < 0.001). The significant heterogeneity remained when analysing only experienced surgeons with a stated experience of at least 250 radical prostatectomies (n=12). Among all participating surgeons (n=68), differences in surgeon volume explained 42% of the observed heterogeneity for incontinence (P = 0.003), 11% for ED (P = 0.03) and 19% for recurrence (P = 0.01). Taking surgeon volume into account when comparing RALP and RRP had a significant impact on the results. The effect was greatest for functional outcomes, and the additional adjustments for the surgeons' previous experience changed whether the difference between techniques was statistically significant or not. The surgeons’ annual volume had the greatest effect on the recurrence rate. Conclusions: There was a large degree of heterogeneity among surgeons regarding both functional and oncological outcomes and this had a significant impact on the results when comparing RALP and RRP. Some of the observed heterogeneity was explained by differences in surgeon volume. Efforts to decrease heterogeneity are warranted and variation among surgeons must be accounted for when conducting comparative analyses between surgical techniques. (Less)

Background Conclusive evidence of superiority in oncological outcome for robot-assisted laparoscopic prostatectomy (RALP) over retropubic radical prostatectomy (RRP) is lacking. Objective To compare RALP and RRP regarding recurrent disease and to report the mortality rate 6 yr after surgery. Design, setting, and participants A total of 4003 men with localized prostate cancer were enrolled between 2008 and 2011 in Laparoscopic Prostatectomy Robot Open (LAPPRO)— a prospective, controlled, nonrandomized trial performed at 14 Swedish centers. Outcome measurements and statistical analysis Data were collected at visits and by patient questionnaires at 3, 12, and 24 mo, and through a structured telephone interview at 6 yr. Cause of death was retrieved from the National Cause of Death Register in Sweden. The modified Poisson regression approach was used for analyses. Results and limitations After adjustment for patient-, tumor-, and surgeon-related confounders, no statistically significant difference was observed between RALP and RRP in biochemical recurrence rate (14 vs 16%, relative risk [RR] 0.77, 95% confidence interval [CI] 0.56–1.06) or in not cured endpoint (22% vs 23%, RR 0.82, 95% CI 0.6–1.11). Stratified by D’Amico risk group, a significant benefit for RALP existed for recurrent disease in high-risk patients (RR 0.47, 95% CI 0.26–0.86, p = 0.02). All-cause mortality was 3% (n = 96). Prostate cancer–specific mortality was 0.6% (n = 21) overall, 0.3% (n = 8) after RALP, and 1.5% (n = 13) after RRP. The nonrandomized design is a limitation. Conclusions No significant difference was observed for cancer recurrence rate between RALP and RRP 6 yr after surgery. However, in a subgroup analysis, we found a significant benefit for RALP regarding recurrence rate in the high-risk group. Larger studies with longer follow-up are needed to make a firm conclusion and to evaluate a possible survival benefit. Patient summary In general, the oncological outcome is comparable between robotic and open radical prostatectomy 6 yr after surgery. For high-risk patients, our findings indicate that there is an advantage for robotics, but further studies with longer follow-up time is needed to make a firm conclusion., Take Home Message Robot-assisted and open retropubic radical prostatectomy have comparable oncological outcome 6 yr after surgery. However, for high-risk patients, we observed a significant benefit for robotics regarding recurrence rate. Longer follow-up time is needed to make a firm conclusion and to evaluate a possible survival benefit for either of the surgical approaches.

Objective The aim of this study is to describe the impact of robotic-assisted surgery on team performance in the operating room. Background The introduction of surgical robots has improved the technical performance of surgical procedures but has also contributed to unexpected interactions in surgical teams, leading to new types of errors. Method A systematic literature search of Cumulative Index to Nursing and Allied Health Literature, PubMed, ProQuest, Cochrane, Web of Science, PsycINFO, and Scopus databases using key words and MeSH terms was conducted. Screening identified studies employing qualitative and quantitative methods published between January 2000 and September 2019. Two reviewers independently appraised the methodological quality of the articles using the Mixed Methods Appraisal Tool (2018). Discussions were held among authors to examine quality scores of the studies and emergent themes, and agreement was reached through consensus. Themes were derived using inductive content analysis. Results Combined searches identified 1,065 citations. Of these, 19 articles, 16 quantitative and 3 qualitative, were included. Robotic-assisted surgeries included urology, gynecology, cardiac, and general procedures involving surgeons, anesthetists, nurses, and technicians. Three themes emerged : Negotiating the altered physical environs and adapting team communications to manage task and technology; managing the robotic system to optimize workflow efficiency; and technical proficiency depends on experience, team familiarity, and case complexity. Conclusion Inclusion of a robot as a team member adds further complexity to the work of surgery. Application These review findings will inform training programs specifically designed to optimize teamwork, workflow efficiency, and learning needs.

Background: Men are more severely affected by COVID-19. Testosterone may influence SARS-CoV-2 infection and the immune response. Objective: To clinically, epidemiologically, and experimentally evaluate the effect of antiandrogens on SARS-CoV-2 infection. Designs, settings, and participants: A randomized phase 2 clinical trial (COVIDENZA) enrolled 42 hospitalized COVID-19 patients before safety evaluation. We also conducted a population-based retrospective study of 7894 SARS-CoV-2–positive prostate cancer patients and an experimental study using an air-liquid interface three-dimensional culture model of primary lung cells. Intervention: In COVIDENZA, patients were randomized 2:1 to 5 d of enzalutamide or standard of care. Outcome measurements: The primary outcomes in COVIDENZA were the time to mechanical ventilation or discharge from hospital. The population-based study investigated risk of hospitalization, intensive care, and death from COVID-19 after androgen inhibition. Results and limitations: Enzalutamide-treated patients required longer hospitalization (hazard ratio [HR] for discharge from hospital 0.43, 95% confidence interval [CI] 0.20–0.93) and the trial was terminated early. In the epidemiological study, no preventive effects were observed. The frail population of patients treated with androgen deprivation therapy (ADT) in combination with abiraterone acetate or enzalutamide had a higher risk of dying from COVID-19 (HR 2.51, 95% CI 1.52–4.16). In vitro data showed no effect of enzalutamide on virus replication. The epidemiological study has limitations that include residual confounders. Conclusions: The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19. Thus, these antiandrogens should not be used for hospitalized COVID-19 patients or as prevention for COVID-19. Further research on these therapeutics in this setting are not warranted. Patient summary: We studied whether inhibition of testosterone could diminish COVID-19 symptoms. We found no evidence of an effect in a clinical study or in epidemiological or experimental investigations. We conclude that androgen inhibition should not be used for prevention or treatment of COVID-19. Funding agencies: This investigator-initiated trial was supported by an unconditional research grant from Astellas Pharma Ltd. The sponsor had no role in the study design; in the data collection, analysis, or interpretation; or in writing the manuscript. AJ is supported by the Knut and Alice Wallenberg Foundation and Swedish Prostate Cancer Federation. KW is supported by the Swedish Cancer Society (CAN 2017/478 and 20 1055 PjF) and the Swedish Prostate Cancer Federation. AKÖ is supported by the Swedish Heart Lung foundation (no. 20200385), and the Knut and Alice Wallenberg Foundation (grants to Science for Life Laboratory, 2020.0182). AMFC is supported by Central ALF-funding, Region Västerbotten (RV-836351), Base unit ALF-funding (RV-939769); Strategic Funding during 2020 from the Department of Clinical Microbiology, Umeå University; and The Laboratory for Molecular Infection Medicine Sweden (MIMS)

Background The optimal follow-up regimen for men after a benign prostate biopsy remains unknown. Objective To investigate long-term outcomes for men after an initial benign prostate biopsy. Design, setting, and participants All men with a benign biopsy in the first screening round of the Goteborg prostate cancer (PC) screening trial were included. The follow-up period was January 1, 1995–May 15, 2017. Intervention Prostate-specific antigen (PSA) tests were performed every second year (upper median age limit 69yr). Men with PSA ≥3ng/ml underwent prostate biopsy (sextant biopsy up to 2009). Outcome measurements and statistical analysis The 20-yr cumulative PC incidence and PC mortality were calculated using the 1 minus Kaplan-Meier method. Results and limitations Of 452 men with a benign biopsy and followed for a median of 21.1yr, 169 were diagnosed with PC and five died from PC. The 20-yr cumulative PC incidence and PC mortality were 40.0% and 1.4%, respectively. The corresponding figures were 38.8% and 0.6% for men with initial PSA ≤10ng/ml, and 64.4% and 21.4% for PSA >10ng/ml. The proportion of men untreated at final follow-up was similar in the two PSA groups (22% vs 23%). The use of sextant biopsy for many years of the trial is a limitation. Conclusions Men with an initial benign prostate biopsy run a very low risk of dying from PC when participating in a screening program. However, if followed for a long period, many men will be diagnosed and treated for PC. Low-intensity follow-up, as in the Goteborg trial, appears sufficient for men with PSA ≤10ng/ml after a benign biopsy. Patient summary This study shows that men who participate in a prostate cancer screening trial have a low risk of dying from prostate cancer if the first biopsy does not show cancer.

Background The Goteborg 2 prostate cancer (PC) screening (G2) trial evaluates screening with prostate-specific antigen (PSA) followed by magnetic resonance imaging (MRI) in case of elevated PSA levels. Objective To assess the safety of using a 2-yr interval in men who were previously screened positive with PSA but had negative MRI or positive MRI with a negative biopsy. Design, setting, and participants A total of 61 201 men aged 50–60 yr were randomized and 38 366 were invited for screening (years 2015–2020). Men with positive MRI (Prostate Imaging Reporting and Data System [PI-RADS] score ≥3) were scheduled for targeted biopsies. Men with negative MRI or negative biopsies were reinvited after 2 yr. Round 1 and 2 MRI scans (PI-RADS ≥3) of men not diagnosed with PC in round 1 were re-read and classified according to Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) by two radiologists. Interval PCs (detected outside the program before invitation to round 2) were identified by linking to the Regional PC Registry. Outcome measurements and statistical analysis Tabulation of overall detection of PC was done. Results and limitations Between October 2017 and June 2020, 474 men with round 1 elevated PSA and MRI underwent a second screening. Of those, 19% had nonelevated PSA in round 2 and were not examined further. Of the remaining 376 men, 89% had negative MRI. Targeted biopsies yielded 14 PCs: nine grade group (GG) 1 and five GG 2–3. In men with PI-RADS ≥3 and PC diagnosed in round 2, only two (GG 1) progressed according to the PRECISE criteria and the remainder were stable. Ten interval PCs were diagnosed: seven GG 1, one GG 2, and two GG 5. The two GG 5 PCs were PI-RADS 4 and 5 with negative round 1 biopsy. Conclusions A 2-yr interval seems to be safe in men with negative MRI, while men with PI-RADS 4 and 5 lesions with negative biopsies should have a closer follow-up. Patient summary In prostate cancer screening, a 2-yr follow-up seems to be safe if magnetic resonance imaging did not show highly suspicious findings.

Background: Increasing age as a risk factor for erectile dysfunction (ED) is in most studies assumed to be a linear function. If this is not the case the assumption could lead to bias, e.g. when me...

To describe study design and procedures for a prospective randomized trial investigating whether radical prostatectomy (RP) ± radiation improves cause-specific survival in comparison with primary radiation treatment (RT) and androgen deprivation treatment (ADT) in patients with locally advanced prostate cancer (LAPC).SPCG-15 is a prospective, multi-centre, open randomized phase III trial. Patients are randomized to either standard (RT + ADT) or experimental (RP with extended pelvic lymph-node dissection and with addition of adjuvant or salvage RT and/or ADT if deemed necessary) treatment. Each centre follows guidelines regarding the timing and dosing of postoperative RT and adjuvant treatment such as ADT The primary endpoint is cause-specific survival. Secondary endpoints include metastasis-free and overall survival, quality-of-life, functional outcomes and health-services requirements. Each subject will be followed up for a minimum of 10 years.Twenty-three centres in Denmark, Finland, Norway and Sweden, well established in performing RP and RT for prostate cancer participated. Each country's sites were coordinated by national coordinating investigators and sub-investigators for urology and oncology. Almost 400 men have been randomized of the stipulated 1200, with an increasing rate of accrual.The SPCG-15 trial aims to compare the two curatively intended techniques supplying new knowledge to support future decisions in treatment strategies for patients with LAPC The Scandinavian healthcare context is well suited for performing multi-centre long-term prospective randomized clinical trials. Similar care protocols and a history of entirely tax-funded healthcare facilitate joint trials.

ObjectivesThe main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalized for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization.Trial designHospitalized COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority.ParticipantsIncluded participants, men or women above 50 years of age, must be hospitalized for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden.Intervention and comparatorPatients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19.Main outcomesThe primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion).RandomisationRandomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina)Blinding (masking)This is an open-label trial.Numbers to be randomised (sample size)The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total.Trial StatusThe current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021.Trial registrationEudract number 2020-002027-10ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020

Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Background Radical prostatectomy reduces mortality among patients with localised prostate cancer. Evidence on whether different surgical techniques can affect mortality rates is lacking. Objective To evaluate functional and oncological outcomes 8 yr after robot-assisted laparoscopic prostatectomy (RALP) and open retropubic radical prostatectomy (RRP). Design, setting, and participants We enrolled 4003 patients in a prospective, controlled, nonrandomised trial comparing RALP and RRP in 14 Swedish centres between 2008 and 2011. Data for functional outcomes were assessed via validated patient questionnaires administered preoperatively and at 12 and 24 mo and 8 yr after surgery. Outcome measurements and statistical analysis The primary endpoint was urinary incontinence. Functional outcomes at 8 yr were analysed using the modified Poisson regression approach. Results and limitations Urinary incontinence was not significantly different at 8 yr after surgery between RALP and RRP (27% vs 29%; adjusted risk ratio [aRR] 1.05, 95% confidence interval [CI] 0.90–1.23). Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; aRR 0.93, 95% CI 0.87–0.99). Prostate cancer–specific mortality (PCSM) was significantly lower in the RALP group at 8 yr after surgery (40/2699 vs 25/885; aRR 0.56, 95% CI 0.34–0.93). Differences in oncological outcomes were mainly seen in the group with high D'Amico risk, with a lower risk of positive surgical margins (21% vs 34%), biochemical recurrence (51% vs 69%), and PCSM (14/220 vs 11/77) for RALP versus RRP. The main limitation is the nonrandomised design. Conclusions In this prospective multicentre controlled trial, PCSM at 8 yr after surgery was lower for RALP in comparison to RRP. A causal relationship between surgical technique and mortality cannot be inferred, but the result confirms that RALP is oncologically safe. Taken together with better short-term results reported elsewhere, our findings confirm that implementation of RALP may continue. Patient summary Our study comparing two surgical techniques for removal of the prostate for localised prostate cancer shows that a robot-assisted minimally invasive technique is safe in the long term. Together with previous results showing some better short-term effects with this approach, our findings support continued use of robot-assisted surgery.

To evaluate urinary continence (UC) recovery and oncological outcomes in different risk-groups after robot-assisted radical prostatectomy (RALP) and open retropubic radical prostatectomy (RRP).We analysed 2650 men with prostate cancer from seven open (n = 805) and seven robotic (n = 1845) Swedish centres between 2008 and 2011 in a prospective non-randomised trial, LAPPRO. UC recovery was defined as change of pads less than once in 24 h. Information was collected through validated questionnaires. Rate of positive surgical margins (PSM) and biochemical recurrence (BCR), defined as prostate-specific antigen (PSA) 0.25 mg/ml, were recorded. We stratified patients into two risk groups (low-intermediate and high risk) based on the D'Amico risk classification system.Among men with high-risk prostate cancer, we found significantly higher rates of UC recovery up to 24 months after RRP compared to RALP (66.1% vs 60.5%) RR 0.85 (CI 95% 0.73-0.99) while PSM was more frequent after RRP compared to RALP (46.8% vs 23.5%) RR 1.56 (CI 95% 1.10-2.21). In the same group no significant difference was seen in BCR. Overall, however, BCR was significantly more common after RRP compared to RALP at 24 months (9.8% vs 6.6%) RR 1.43 (Cl 95% 1.08-1.89). The limitations of this study are its non-randomized design and the relatively short time of follow-up.Our study indicates that men with high-risk tumour operated with open surgery had better urinary continence recovery but with a higher risk of PSM than after robotic-assisted laparoscopic surgery. No significant difference was seen in biochemical recurrence. TRIAL REGISTRATION: ISRCTN06393679.

Objective: The primary aim of this study was to evaluate the scientific evidence supporting the use of thermal dose as a secondary (or an alternative) endpoint when using the CoreTherm Concept.Mate...

Objective: The incidence of urinary stones is increasing across the globe. Surgical treatment includes extracorporal shock-wave lithotripsy (ESWL), ureterolithotripsy (URS), percutaneous nephrolito...

Objective: To evaluate the long-term outcome of men with an initial prostate-specific antigen (PSA) level below 3 ng/mL and whether the free-to-total (F/T PSA) ratio is a useful prognostic marker in this range. Materials and methods: This study is based on 5,174 men aged 50–66 years, who in 1995–1996 participated in the first round of the Goteborg randomized screening trial (initial T-PSA level

Background Whether surgeons perform better utilising a robot-assisted laparoscopic technique compared with an open approach during prostate cancer surgery is debatable. Objective To report erectile function and early oncologic outcomes for both surgical modalities, stratified by prostate cancer risk grouping. Design, setting, and participants In a prospective nonrandomised trial, we recruited 2545 men with prostate cancer from seven open ( n =753) and seven robot-assisted ( n =1792) Swedish centres (2008–2011). Outcome measurements and statistical analysis Clinometrically-validated questionnaire-based patient-reported erectile function was collected before, 3 mo, 12 mo, and 24 mo after surgery. Surgeon-reported degree of neurovascular-bundle preservation, pathologist-reported positive surgical margin (PSM) rates, and 2-yr prostate-specific antigen-relapse rates were measured. Results and limitations Among 1702 preoperatively potent men, we found enhanced erectile function recovery for low/intermediate-risk patients in the robot-assisted group at 3 mo. For patients with high-risk tumours, point estimates for erectile function recovery at 24 mo favoured the open surgery group. The degree of neurovascular bundle preservation and erectile function recovery were greater correlated for robot-assisted surgery. In pT2 tumours, 10% versus 17% PSM rates were observed for open and robot-assisted surgery, respectively; corresponding rates for pT3 tumours were 48% and 33%. These differences were associated with biochemical recurrence in pT3 but not pT2 disease. The study is limited by its nonrandomised design and relatively short follow-up. Conclusions Earlier recovery of erectile function in the robot-assisted surgery group in lower-risk patients is counterbalanced by lower PSM rates for open surgeons in organ-confined disease; thus, both open and robotic surgeons need to consider this trade-off when determining the plane of surgical dissection. Robot-assisted surgery also facilitates easier identification of nerve preservation planes during radical prostatectomy as well as wider dissection for pT3 cases. Patient summary For prostate cancer surgery, an open operation reduces erection problems in high-risk cancers but has higher relapse rates than robotic surgery. Relapse rates appear similar in low/intermediate-risk cancers and the robot appears better at preserving erections in these cases.

Objective: This study examined whether previously reported results, indicating that prostate-specific antigen (PSA) screening can reduce prostate cancer (PC) mortality regardless of sociodemographi...

Objective Studies indicate that social constraints (barriers to emotional expression) may be a risk factor for psychological morbidity. We aimed to investigate the association between prostate cancer- related social constraints and psychological well-being following prostate cancer surgery. Methods In a group of 3478 partnered patients, participating in the Laparoscopic Prostatectomy Robot Open (LAPPRO) trial, a prospective multicenter comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer, we used log-binomial regression analysis to investigate the links between prostate cancer-related social constraints at 3 months after surgery and psychological well-being at 12 and 24 months. Results 1086 and 1093 men reported low well-being at 12 and 24 months, respectively. Prostate cancer-related social constraints by partner predicted low psychological well-being at 12 months (adjusted RR: 1.4; 95% CI, 1.1-1.9) and by others (adjusted RR: 1.9; 95% CI, 1.1-3.5). Intrusive thoughts mediated the association. Conclusions Negative responses from the social environment, especially from partner to talking about the prostate cancer experience affected patients' psychological well-being two years after radical prostatectomy. Results emphasize the importance of helping patients mobilize psychosocial resources within their social network, especially among those with a lack of quality psychosocial support.

We were interested in examining if there was a link between self-assessed emotional shock by prostate cancer diagnosis and psychological well-being at 3, 12, and 24 months after surgery.Information was derived from patients participating in the LAPAroscopic Prostatectomy Robot Open (LAPPRO) trial, Sweden. We analyzed the association between self-assessed emotional shock upon diagnosis and psychological well-being by calculating odds ratios (ORs).A total of 2426 patients (75%) reported self-assessed emotional shock by the prostate cancer diagnosis. Median age of study participants was 63. There was an association between emotional shock and low psychological well-being after surgery: adjusted OR 1.7: (95% confidence interval [CI]), 1.4-2.1 at 3 months; adjusted OR 1.3: CI, 1.1-1.7 at 12 months, and adjusted OR 1.4: CI, 1.1-1.8 at 24 months. Among self-assessed emotionally shocked patients, low self-esteem, anxiety, and having no one to confide in were factors more strongly related with low psychological well-being over time.Experiencing self-assessed emotional shock by prostate cancer diagnosis may be associated with low psychological well-being for up to two years after surgery. Future research may address this high rate of self-assessed emotional shock after diagnosis with the aim to intervene to avoid this negative experience to become drawn out.

Objective Negative intrusive thoughts about one's prostate cancer have been associated with depressive mood and impaired quality of life among prostate cancer patients. However, little is known about possible predictors for negative intrusive thoughts among this group. We aimed to identify health- and care-related predictors for such thoughts among a population of men newly diagnosed with prostate cancer and undergoing radical prostatectomy. Methods In the LAPPRO-trial, 3154 men (80%) answered study-specific questionnaires at admission and 3 months after surgery. Questions concerned socio-demographics, health, uncertainty, preparedness for symptoms, and the outcome—negative intrusive thoughts. Associations between variables were analyzed by log-binominal and multivariable approach. Results The strongest predictor of negative intrusive thoughts at admission to surgery was uncertainty of cure, followed by binge drinking, poor physical health, antidepressant medication, not being prepared for urinary symptoms, age under 55, and physical pain. Reporting it not probable to obtain urinary symptoms after surgery lowered the odds. Negative intrusive thoughts before surgery were the strongest predictor for such thoughts 3 months later followed by uncertainty of cure, physical pain, younger age, living alone, and poor self-reported physical health. Conclusions Our findings showed an association of preoperative uncertainty of cure as well as low preparedness for well-known surgery-induced symptoms with higher occurrence of negative intrusive thoughts about prostate cancer. Future studies should examine if interventions designed to have healthcare professionals inform patients about their upcoming prostatectomy reduce patients' negative intrusive thoughts and thereby, improve their psychological well-being.

Background Active surveillance (AS) has become a well-accepted and widely used treatment strategy. Objective To assess the long-term safety of AS for men with screen-detected prostate cancer (PCa). Design, setting, and participants All men with screen-detected PCa who had very low-, low-, or intermediate-risk PCa and were managed with AS (January 1, 1995 to December 31, 2014) in the Goteborg screening trial. Intervention Prostate-specific antigen tests every 3–12 mo, rebiopsies in cases of clinical progression, and every 2–3 yr in men with stable disease. Triggers for intervention were disease progression (prostate-specific antigen, grade, and/or stage) or patient initiative. Outcomes measurements and statistical analysis Treatment-free, failure-free, PCa-specific, and overall survival. The Kaplan-Meier method and Cox proportional hazards models were used. Results and limitations Four-hundred and seventy-four men were managed with AS (median age at diagnosis 66.0 yr, median follow-up 8.0 yr). Two-hundred and two men discontinued AS and initiated treatment. The 10-yr and 15-yr treatment-free survival was 47% and 34%, respectively. The hazard ratio for the treatment for low- and intermediate-risk PCa, compared with very low risk, was 1.4 (95% confidence interval [CI] 1.01–1.94) and 1.6 (95% CI 1.13–2.25). Fifty-four men failed AS. The 10-yr and 15-year failure-free survival was 87% and 72%, respectively. These estimates were 94% and 88% for the very low-risk group, 85% and 77% for the low-risk group, and 73% and 40% for the intermediate-risk group. The hazard ratio for failure for low- and intermediate-risk PCa, compared with very low-risk, was 2.2 (95% CI 1.05–4.47) and 4.8 (95% CI 2.44–9.33). Six men died from PCa and none had very low-risk PCa. The 10-yr and 15-yr PCa-specific survival was 99.5% and 96%, respectively. These estimates were 100% for the very low-risk group, 100% and 94% for the low-risk group, and 98% and 90% for the intermediate-risk group. No predefined protocol was used. Conclusions AS is safe for men with very low-risk PCa, but for men with low- and intermediate-risk PCa, AS carries a risk of missing the possibility of being able to cure the cancer. It is questionable whether men who are not in the lowest tumor risk group and who have a long remaining life expectancy are suitable candidates for this strategy. Patient summary Long-term results from this study indicate that some men will miss their chance of cure with active surveillance and it is questionable whether active surveillance is a suitable strategy for men who are not in the lowest tumor risk group and who have a very long remaining life expectancy.

Introduction The aim of this study was to describe the complications of ureteroscopy (URS) and to investigate whether performing URS outside normal working hours leads to increased risk for clinically significant complications. Material and methods A cohort of 486 consecutive patients treated with URS, with a total of 567 sessions between 2009 and 2015 at Helsingborg/Angelholm Hospital, Sweden, was analyzed. Outcome was complications within 14 days after URS treatment. Results We found no increased risk of complications related to URS performed outside normal working hours. Stone-free rate (SFR) in the distal third of the ureter was 95.2% (315/331), in the middle ureter 92.8% (90/97), in the proximal ureter 84.0% (63/75) and 69.0% (40/58) in renal pelvis. The overall complication rate was 10.6% (n = 60). None of the potential risk factors for complications showed any significance when adjusted for age and gender. We found an inverse relationship between stenting and SFR (p = 0.002). The most common preoperatively cultured bacteria was Escherichia coli. With adequate antibiotics, there was no increased risk of complications. There was an increased risk of complications after URS related to age, but not with gender. Conclusions URS in modern setting provides excellent results with adequate SFR and low morbidity. Time of day, the presence of urological specialized operating nurses did not affect the risk of complications and we found no other significant risk factors for complications. Escherichia coli was the most commonly found bacteria in preoperative cultures. The risk of complications increases with age. For patients >65 years old, this should be considered in preoperative counseling.

PURPOSE: The demand for objective and outcome-based facts about surgical results after radical prostatectomy (RP) is increasing. Systematic feedback is also essential for each surgeon to improve his/her performance. METHODS: RP outcome data (e.g., pT-stage and margin status) have been registered at Sahlgrenska University Hospital (SUH) since 1988 and patient-related outcome measures (PROM) have been registered since 2001. The National Prostate Cancer Registry (NPCR) has covered all Regions in Sweden since 1998 and includes PROM-data from 2008. Initially PROM was on-paper questionnaires but due since 2018 all PROMs are collected electronically. In 2014 an on-line "dashboard" panel was introduced, showing the results for ten quality-control variables in real-time. Since 2017 all RP data on hospital, regional, and national levels are publicly accessible on-line on " www.npcr.se/RATTEN ". RESULTS: The early PROM-data from SUH have been used for internal quality control. As national clinical and PROM-data from the NPCR have been made accessible on-line and in real-time we have incorporated this into our pre-existing protocol. Our data are now internally available as real-time NPCR reports on the individual surgeons' results, as well as ePROM data. We can compare the results of each surgeon internally and to other departments' aggregated data. The public can access data and compare hospital level data on "RATTEN". CONCLUSIONS: The process of quality control of RP locally at SUH, and nationally through the NPCR, has been long but fruitful. The online design, with direct real-time feedback to the institutions that report the data, is essential.

Publisher's version (útgefin grein)., Background: Little is known concerning what may infuence surgeon satisfaction with a surgical procedure and its associations with intraoperative factors. The objective was to explore the relationships between surgeons’ self-assessed satisfaction with performed radical prostatectomies and intraoperative factors such as technical difculties and intraoperative complications as reported by the surgeon subsequent to the operation. Methods: We utilized prospectively collected data from the controlled LAPPRO trial where 4003 patients with prostate cancer underwent open (ORP) or robot-assisted laparoscopic (RALP) radical prostatectomy. Patients were included from fourteen centers in Sweden during 2008–2011. Surgeon satisfaction was assessed by questionnaires at the end of each operation. Intraoperative factors included time for the surgical procedure as well as difculties and complications in various steps of the operation. To model surgeon satisfaction, a mixed efect logistic regression was used. Results were presented as odds ratios (OR) with 95% confdence intervals (CI). Results: The surgeons were satisfed in 2905 (81%) and dissatisfed in 702 (19%) of the surgical procedures. Surgeon satisfaction was not statistically associated with type of surgical technique (ORP vs. RALP) (OR 1.36, CI 0.76; 2.43). Intraoperative factors such as technical difculties or complications, for example, suturing of the anastomosis was negatively associated with surgeon satisfaction (OR 0.24, CI 0.19; 0.30). Conclusions: Our data indicate that technical difculties and/or intraoperative complications were associated with a surgeon’s level of satisfaction with an operation., This study was supported by research grants from the Swedish Cancer Society (2008/922, 2010/593, 2013/497, 2016/362), The Swedish Research Council (2012-1770, 2015-02483), Region Västra Götaland, Sahlgrenska University Hospital (ALF grants 138751, 146201, and 4307771, HTA-VGR 6011; agreement concerning research and education of doctors), Mrs. Mary von Sydow Foundation, and Anna and Edvin Berger Foundation.