The association between pre-diagnostic levels of psychological distress and adverse effects after radical prostatectomy.

Objectives: To prospectively analyse the associations between pre-diagnostic levels of anxiety and depression and patient-reported urinary and sexual adverse effects after radical prostatectomy in a population-based setting. Patients and Methods: In three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient-reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5-score. Additional PROM questionnaires, including the EPIC-26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups. Results: A total of 416 men were included at baseline and of those, 365 (88%) returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high-distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate-distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low-distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident. Conclusion: Men with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision-making and during follow-up after radical prostatectomy.

Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged ≥75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P).

BACKGROUND: Older men (aged ≥75 years) with high risk, non-metastatic prostate cancer (PCa) are increasingly treated with curative therapy (surgery or radiotherapy). However, it is unclear if curative therapy prolongs life and improves health-related quality of life (HRQoL) in this age group compared to conservative therapy, which has evolved considerably during the last decade. STUDY DESIGN: The Scandinavian Prostate Cancer Group (SPCG) 19/Norwegian Get-Randomized Research Group-Prostate (GRand-P) is a randomised, two-armed, controlled, multicentre, phase III trial carried out at study centres in Norway, Denmark, Finland, and Sweden. ENDPOINTS: The primary endpoints are overall survival and HRQoL (burden of disease scale, European Organisation for the Research and Treatment of Cancer [EORTC] Elderly Cancer patients). Secondary endpoints are PCa-specific survival, metastasis-free survival, role-functioning scale (EORTC quality of life questionnaire 30-item core), urinary irritative/obstructive scale (26-item Expanded Prostate Cancer Index Composite [EPIC-26]), bowel scale (EPIC-26), intervention-free survival, PCa morbidity, use of secondary and tertiary systemic therapies, mean quality-adjusted life-years (QALYs), and mean total healthcare costs. PATIENTS AND METHODS: A total of 980 men (aged ≥75 years) with non-metastatic, high-risk PCa will initially be screened with Geriatric 8 (G8) health status screening tool and Mini-COG© brief cognitive test. Participants identified by G8 as 'fit' or 'frail' will be randomised (ratio 1:1) to either immediate curative therapy (radiotherapy or prostatectomy) or conservative therapy (endocrine therapy or observation). Participants who are unable or unwilling to participate in randomisation will be enrolled in a separate observation group. Randomised patients will be followed for 10 years. TRIAL REGISTRATION: Ethics approval has been granted in Norway (457593), Denmark (H-22051998), Finland (R23043) and Sweden (Dnr 2023-05296-01). The trial is registered on Clinicaltrials.org (NCT05448547).

Do all prostate cancer patients want, and experience shared decision making prior to curative treatment?

OBJECTIVE: In comparable men with non-metastatic prostate cancer, radical prostatectomy (RP), radiotherapy (RAD) and active surveillance (AS) are treatment options with similar survival rates, but different side-effects. Healthcare professionals consider pretreatment shared decision making (SDM) to be an essential part of medical care, though the patients' view about SDM is less known. In this article, we explore prostate cancer (PCa) patients' SDM wish (SDMwish), and experiences (SDMexp).  Material and methods: This is a registry-based survey performed by the Cancer Registry of Norway (2017-2019). One year after diagnosis, 5,063 curatively treated PCa patients responded to questions about their pre-treatment wish and experience regarding SDM. Multivariable analyses identified factors associated with SDM. Statistical significance level: p < 0.05.  Results: Overall, 78% of the patients wished to be involved in SDM and 83% of these had experienced SDM. SDMwish and SDMexp was significantly associated with decreasing age, increasing education, and living with a partner. Compared with the RP group, the probability of SDMwish and SDMexp was reduced by about 40% in the RAD and the AS groups.  Conclusion: Three of four curatively treated PCa wanted to participate in SDM, and this wish was met in four of five men. Younger PCa patients with higher education in a relationship, and opting for RP, wanted an active role in SDM, and experienced being involved. Effective SDM requires the responsible physicians' attention to the individual patients' characteristics and needs.

Impact of prebiopsy MRI on prostate cancer staging: Results from the Norwegian Prostate Cancer Registry.

Objectives: The aim of this study is to evaluate the 2015 introduction of prebiopsy magnetic resonance imaging of the prostate (MRI-P) as the standard of care for diagnosing prostate cancer (PCa) by the Norwegian public health care authorities. There were three specific objectives of this study: first, to evaluate the consequences of using different TNM manuals for clinical T-staging (cT-staging) in a national setting; second, to determine if the data reveals that MRI-P based cT-staging is superior to digital rectal examination (DRE)-based cT-staging compared with pathological T-stage (pT-stage) post radical prostatectomy; and third, to assess whether treatment allocations have changed over time. Materials and Methods: All patients registered in the Norwegian Prostate Cancer Registry between 2004 and 2021 were retrieved and 5538 were eligible for inclusion. Concordance between clinical T-stage (cT-stage) and pT-stage was assessed by percentage agreement, Cohen's kappa and Gwet's agreement. Results: MR visualisation of lesions influences reporting of tumour extension beyond DRE findings. Agreement between cT-stage and pT-stage declined from 2004 to 2009, which coincided with an increase in the percentage being pT3. From 2010, agreement increased, which aligned with changes in cT-staging and the introduction of MRI-P. From 2017, regarding the reporting of cT-DRE and cT-Total (overall cT-stage), agreement diminished for cT-DRE but remained relatively stable (>60%) for cT-Total. Regarding treatment allocation, the study suggests that staging with MRI-P has shifted treatment towards radiotherapy in locally advanced high-risk disease. Conclusion: Introduction of MRI-P has affected cT-stage reporting. Agreement between cT-stage and pT-stage appears to have improved. This study suggests that use of MRI-P influences treatment decisions in certain patient subgroups.

Increased magnetic resonance imaging in prostate cancer management-What are the outcomes?

RATIONALE: Increased attention to cancer care has instigated altered systems for screening, diagnosis, and management of various types of cancer, such as in the prostate. While such systems very likely have improved the quality of cancer care, they also result in the altered use of specific services, such as magnetic resonance imaging (MRI). AIMS AND OBJECTIVE: To study the change in the use of prostate MRI in the Norwegian health care system from 2013 to 2021 and to investigate some reasons for and potential implications of this change. METHOD: Data from the Norwegian Health Economics Administration (HELFO), The Cancer Registry of Norway and Cause-of-death registry at the Norwegian Institute of public health and the health registry of Vestfold Hospital Trust were used for descriptive statistical analysis. RESULTS: The number of MRIs of the prostate increased threefold from 2013 to 2021, representing an extra cost of 2 million USD in 2020. The incidence of prostate cancer was stable at about 5000 cases per year, corresponding to 178 per 100,000 men, indicating no increased overdiagnosis. However, the clinical staging has changed substantially during this period, indicating stage and grade migration. The number of negative biopsies was reduced, and there are three MRIs per reduced negative biopsy. The number of persons on active surveillance increased during the period. However, these changes are partly independent of the increase in the number of MRIs. CONCLUSION: There was a substantial increase in the number of prostate MRIs and thus an increase in costs. This appears to have contributed to the reduction of negative biopsies, improved staging and increased active surveillance. However, as these effects are partly independent of the increase in MRIs, we need to document the outcomes for patients from prostate MRIs as their opportunity costs are substantial.

Predicting the Need for Biopsy to Detect Clinically Significant Prostate Cancer in Patients with a Magnetic Resonance Imaging-detected Prostate Imaging Reporting and Data System/Likert ≥3 Lesion: Development and Multinational External Validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis Risk Score.

BACKGROUND: Although multiparametric magnetic resonance imaging (MRI) has high sensitivity, its lower specificity leads to a high prevalence of false-positive lesions requiring biopsy. OBJECTIVE: To develop and externally validate a scoring system for MRI-detected Prostate Imaging Reporting and Data System (PIRADS)/Likert ≥3 lesions containing clinically significant prostate cancer (csPCa). DESIGN, SETTING, AND PARTICIPANTS: The multicentre Rapid Access to Prostate Imaging and Diagnosis (RAPID) pathway included 1189 patients referred to urology due to elevated age-specific prostate-specific antigen (PSA) and/or abnormal digital rectal examination (DRE); April 27, 2017 to October 25, 2019. INTERVENTION: Visual-registration or image-fusion targeted and systematic transperineal biopsies for an MRI score of ≥4 or 3 + PSA density ≥0.12 ng/ml/ml. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Fourteen variables were used in multivariable logistic regression for Gleason ≥3 + 4 (primary) and Gleason ≥4 + 3, and PROMIS definition 1 (any ≥4 + 3 or ≥6 mm any grade; secondary). Nomograms were created and a decision curve analysis (DCA) was performed. Models with varying complexity were externally validated in 2374 patients from six international cohorts. RESULTS AND LIMITATIONS: The five-item Imperial RAPID risk score used age, PSA density, prior negative biopsy, prostate volume, and highest MRI score (corrected c-index for Gleason ≥3 + 4 of 0.82 and 0.80-0.86 externally). Incorporating family history, DRE, and Black ethnicity within the eight-item Imperial RAPID risk score provided similar outcomes. The DCA showed similar superiority of all models, with net benefit differences increasing in higher threshold probabilities. At 20%, 30%, and 40% of predicted Gleason ≥3 + 4 prostate cancer, the RAPID risk score was able to reduce, respectively, 11%, 21%, and 31% of biopsies against 1.8%, 6.2%, and 14% of missed csPCa (or 9.6%, 17%, and 26% of foregone biopsies, respectively). CONCLUSIONS: The Imperial RAPID risk score provides a standardised tool for the prediction of csPCa in patients with an MRI-detected PIRADS/Likert ≥3 lesion and can support the decision for prostate biopsy. PATIENT SUMMARY: In this multinational study, we developed a scoring system incorporating clinical and magnetic resonance imaging characteristics to predict which patients have prostate cancer requiring treatment and which patients can safely forego an invasive prostate biopsy. This model was validated in several other countries.

Predictors of upgrading from low-grade cancer at prostatectomy in men with biparametric magnetic resonance imaging.

Introduction: Prostate-specific antigen (PSA) density has previously been identified as a predictor of histological upgrading at radical prostatectomy, but how information from pre-treatment biparametric magnetic resonance imaging (bpMRI) contributes needs further clarification. The objective of this register-based study was to identify predictors of upgrading at prostatectomy in men with Grade group (GG) 1 and pre-treatment bpMRI. Material and methods: This single-center study included men with GG 1 cancer on prediagnostic biopsy, who underwent bpMRI and robotic-assisted radical prostatectomy (RARP) between March 2014 and September 2019. We estimated logistic regression models to explore predictors for upgrading. The explored potential predictors were age, PSA density, tumor stage and Prostate Imaging Reporting and Data System (PI-RADS) score (dichotomised 1-3 versus 4-5). Results: Upgrading was observed in 56% (73/130) of the men. PSA density was the only significant predictor for upgrading (unadjusted OR = 1.7, 95% CI 1.2; 2.4 adjusted OR = 1.7, 95% CI 1.2; 2.5). The probability of upgrading was lower for men with a PIRADS 1-3 than for PIRADS 4-5, but the difference was not statistically significant (adjusted OR 0.4, 95% CI 0.2; 1.1, p = 0.082). Among men with PI-RADS 1-3, the probability increased with increasing PSA density (p = 0.036). With PI-RADS 4-5 the probability of upgrading was high over the entire PSA density range. Conclusions: PSA density is a clinically important factor to predict upgrading from GG1 when bpMRI shows PI-RADS 1-3. In men with PI-RADS 4-5 on bpMRI, the probability of an undetected GG 2-5 cancer is high regardless of the PSA density.

No significant difference in intermediate key outcomes in men with low- and intermediate-risk prostate cancer managed by active surveillance.

Active surveillance (AS) is standard of care for patients with low-risk prostate cancer (PCa), but its feasibility in intermediate-risk patients is controversial. We compared outcomes of low- and intermediate-risk patients managed with multiparametric magnetic resonance imaging (mpMRI)-supported AS in a community hospital. Of the 433 patients enrolled in AS between 2009 and 2016, 358 complied with AS inclusion criteria (Cancer of the Prostate Risk Assessment (CAPRA) score ≤ 5, Gleason grade group (GGG) ≤ 2, clinical stage ≤ cT2 and prostate-specific antigen (PSA) ≤ 20 ng/ml) and discontinuation criteria (histological-, PSA-, clinical- or radiological disease reclassification). Of the 358 patients, 177 (49%) were low-risk and 181 (51%) were intermediate-risk. Median follow-up was 4.2 years. The estimated 5-year treatment-free survival (TFS) was 56% (95% confidence interval [CI] 51-62%). Intermediate-risk patients had significantly shorter TFS compared with low-risk patients (hazard ratio 2.01, 95% CI 1.47-2.76, p < 0.001). There were no statistically significant differences in the rate of adverse pathology, biochemical recurrence-free survival and overall survival between low- and intermediate-risk patients. Two patients developed metastatic disease and three died of PCa. These results suggest that selected patients with intermediate-risk PCa may be safely managed by mpMRI-supported AS, but longer follow-up is necessary.

Compliance with recommended cancer patient pathway timeframes and choice of treatment differed by cancer type and place of residence among cancer patients in Norway in 2015-2016.

BACKGROUND: Cancer patient pathways (CPPs) were implemented in Norway to reduce unnecessary waiting times, regional variations, and to increase the predictability of cancer care for the patients. This study aimed to determine if 70% of cancer patients started treatment within the recommended time frames, and to identify potential delays. METHODS: Patients registered with a colorectal, lung, breast, or prostate cancer diagnosis at the Cancer Registry of Norway in 2015-2016 were linked with the Norwegian Patient Registry and Statistics Norway. Adjusting for sociodemographic variables, multivariable quantile (median) regressions were used to examine the association between place of residence and median time to start of examination, treatment decision, and start of treatment. RESULTS: The study included 20 668 patients. The proportions of patients who went through the CPP within the recommended time frames were highest among colon (84%) and breast (76%) cancer patients who underwent surgery and lung cancer patients who started systemic anticancer treatment (76%), and lowest for prostate cancer patients who underwent surgery (43%). The time from treatment decision to start of treatment was the main source of delay for all cancers. Travelling outside the resident health trust prolonged waiting time and was associated with a reduced odds of receiving surgery and radiotherapy for lung and rectal cancer patients, respectively. CONCLUSIONS: Achievement of national recommendations of the CCP times differed by cancer type and treatment. Identified bottlenecks in the pathway should be targeted to decrease waiting times. Further, CPP guidelines should be re-examined to determine their ongoing relevance.

Tumor cell invasion in blood vessels assessed by immunohistochemistry is related to decreased survival in patients with bladder cancer treated with radical cystectomy.

BACKGROUND: Lymphovascular invasion (VI) is an established prognostic marker for many cancers including bladder cancer. There is a paucity of data regarding whether the prognostic significance of lymphatic invasion (LVI) differs from blood vessel invasion (BVI). The aim was to examine LVI and BVI separately using immunohistochemistry (IHC), and investigate their associations with clinicopathological characteristics and prognosis. A secondary aim was to compare the use of IHC with assessing VI on standard HAS (hematoxylin-azophloxine-saffron) sections without IHC. METHODS: A retrospective, population -based series of 292 invasive bladder cancers treated with radical cystectomy (RC) with curative intent at Vestfold Hospital Trust, Norway were reviewed. Traditional histopathological markers and VI based on HAS sections were recorded. Dual staining using D2-40/CD31 antibodies was performed on one selected tumor block for each case. RESULTS: The frequency of LVI and BVI was 32 and 28%, respectively. BVI was associated with features such as higher pathological stages, positive regional lymph nodes, bladder neck involvement and metastatic disease whereas LVI showed weaker or no associations. Both BVI and LVI independently predicted regional lymph node metastases, LVI being the slightly stronger factor. BVI, not LVI predicted higher pathological stages. BVI showed reduced recurrence free (RFS) and disease specific (DSS) survival in uni-and multivariable analyses, whereas LVI did not. On HAS sections, VI was found in 31% of the cases. By IHC, 51% were positive, corresponding to a 64% increased sensitivity in detecting VI. VI assessed without IHC was significantly associated with RFS and DSS in univariable but not multivariable analysis. CONCLUSIONS: Our findings indicate that BVI is strongly associated with more aggressive tumor features. BVI was an independent prognostic factor in contrast to LVI. Furthermore, IHC increases VI sensitivity compared to HAS.

Fear of Recurrence in Prostate Cancer Patients: A Cross-sectional Study After Radical Prostatectomy or Active Surveillance.

BACKGROUND: Fear of recurrence (FoR) is a distressing consequence of cancer. Little is known about the prevalence of FoR in different treatment groups and factors associated with FoR among prostate cancer (PCa) survivors. OBJECTIVE: To investigate the prevalence of high FoR among PCa survivors after radical prostatectomy (RP) or under active surveillance (AS) and to explore clinical and psychological factors potentially associated with FoR. DESIGN SETTING AND PARTICIPANTS: This is a retrospective cross-sectional study of 606 patients with PCa, treated with either RP (n = 442) or AS (n = 164) at two Norwegian regional hospitals. The 440 patients (73%) who gave consent to participate were invited in 2017 to complete a questionnaire measuring FoR, self-rated health, adverse effects, and psychological factors at a mean of 4.1 yr (standard deviation 1.7) after their treatment decision. Clinical data were retrieved from medical records. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: FoR was measured using the Concerns About Recurrence Questionnaire, with high FoR defined as a sum score of =12 points (range 0-40). Using multivariable logistic regression analyses, factors associated with high FoR were identified. RESULTS AND LIMITATIONS: One-third of the participants had high FoR; scores were higher in the AS group and in the RP group with treatment failure. Younger age was significantly associated with high FoR in the AS group, while high prostate-specific antigen at diagnosis, biochemical recurrence, positive surgical margin, higher fatigue, and a type D personality were significantly associated with high FoR in the RP group. CONCLUSIONS: At 4 yr after a diagnosis of PCa, high FoR was common, especially among AS patients and among RP patients with treatment failure. PATIENT SUMMARY: In this study, we examined fear that their disease will return or progress among prostate cancer survivors. We found that such fear was common, especially among young patients under active surveillance and among radical prostatectomy patients with treatment failure or with certain psychological features.

Which data are available in central registries on bladder cancer patients in the five Nordic countries.

OBJECTIVE: The aim of this study was to give a collective overview on all available data sources on bladder cancer patients in the Nordic countries including the amount of detail and coverage. METHODS: National representatives from five Nordic countries were asked to fill out a questionnaire on available information regarding bladder cancer patients from databases in their respective countries. Additional information was retrieved from descriptions of the relevant registries. RESULTS: Non-muscle invasive bladder cancer: from all countries, information on stage and grade at transurethral resection of the bladder (TURB) could be retrieved. Details on procedures (TURB, instillation therapy, photodynamic diagnosis, and perioperative instillation) were varying within different databases. Muscle invasive bladder cancer: in all Nordic countries, detailed information on cystectomy patients could be retrieved but with variable registration of complications. Completeness of available information on oncological treatment (radiation, chemotherapy, and immunotherapy) were varying. Oncological outcome: Information on overall survival was available in all countries whereas recurrence-free survival and cancer-specific survival were available for some but not all patients depending on treatment modality. CONCLUSIONS: Despite limitations, we found that it was possible to retrieve detailed information on diagnostics, treatment, and outcome for most aspects of bladder cancer in the Nordic countries on a population based, non-selected patient cohort.

Effect of information on prostate biopsy history on biopsy outcomes in the era of MRI-targeted biopsies.

PURPOSE: To describe the predictive value of information on previous benign biopsy for the outcome of MRI-targeted biopsies. METHODS: An exploratory analysis was conducted using data from a prospective, multicenter, paired diagnostic study of 532 men undergoing diagnostics for prostate cancer during 2016-2017. All men underwent 1.5 T MRI; systematic prostate biopsies; and MRI-targeted biopsies to MRI lesions with Prostate Imaging Reporting and Data System version 2, PI-RADS ≥ 3. The main outcome was numbers of detected prostate cancer characterized by grade group (GG) where GG ≥ 2 defined clinically significant cancer (csPCa). RESULTS: Men with previous biopsies had significantly more often negative MRI (26% vs. 17%, p < 0.05) compared to men without previous biopsies. Men with previous biopsies showed higher rates of benign biopsies (41% vs. 26%, p < 0.05) and lower rates of GG2 (17% vs. 30%, p < 0.05) and GG ≥ 3 (5% vs. 10%, p < 0.05) cancer. Biopsy-naïve men had higher proportions of highly suspicious MRI lesions (PIRADS 5; p < 0.05) and a higher proportion of significant cancer in those lesions (p = 0.05). In multivariate regression analysis, a previous benign prostate biopsy was associated with less than half the odds of csPCa (OR 0.38; 95% CI 0.20-0.71). CONCLUSION: In this large prospective multicenter trial, we showed that men with a previous prostate biopsy had higher proportions of MRIs without lesions and lower proportion of highly suspicious lesions than biopsy-naïve men. Further, biopsy-naïve men showed higher detection of clinically significant cancer when using MRI-targeted biopsies. Also, in the era of MRI-targeted biopsy strategies, biopsy history should be carefully considered in biopsy decisions. TRIAL REGISTRATION: NCT02788825 (ClinicalTrials.gov). Date of registration June 2, 2016.

Patient and tumour characteristics associated with inclusion in Cancer patient pathways in Norway in 2015-2016.

BACKGROUND: Cancer patient pathways (CPPs) were implemented in 2015 to reduce waiting time, regional variation in waiting time, and to increase the predictability of cancer care for the patients. The aims of this study were to see if the national target of 70% of all cancer patients being included in a CPP was met, and to identify factors associated with CPP inclusion. METHODS: All patients registered with a colorectal, lung, breast or prostate cancer diagnosis at the Cancer Registry of Norway in the period 2015-2016 were linked with the Norwegian Patient Registry for CPP information and with Statistics Norway for sociodemographic variables. Multivariable logistic regression examined if the odds of not being included in a CPP were associated with year of diagnosis, age, sex, tumour stage, marital status, education, income, region of residence and comorbidity. RESULTS: From 2015 to 2016, 30,747 patients were diagnosed with colorectal, lung, breast or prostate cancer, of whom 24,429 (79.5%) were included in a CPP. Significant increases in the probability of being included in a CPP were observed for colorectal (79.1 to 86.2%), lung (79.0 to 87.3%), breast (91.5 to 97.2%) and prostate cancer (62.2 to 76.2%) patients (p < 0.001). Increasing age was associated with an increased odds of not being included in a CPP for lung (p < 0.001) and prostate cancer (p < 0.001) patients. Colorectal cancer patients < 50 years of age had a two-fold increase (OR = 2.23, 95% CI: 1.70-2.91) in the odds of not being included in a CPP. The odds of no CPP inclusion were significantly increased for low income colorectal (OR = 1.24, 95%CI: 1.00-1.54) and lung (OR = 1.52, 95%CI: 1.16-1.99) cancer patients. Region of residence was significantly associated with CPP inclusion (p < 0.001) and the probability, adjusted for case-mix ranged from 62.4% in region West among prostate cancer patients to 97.6% in region North among breast cancer patients. CONCLUSIONS: The national target of 70% was met within 1 year of CPP implementation in Norway. Although all patients should have equal access to CPPs, a prostate cancer diagnosis, older age, high level of comorbidity or low income were significantly associated with an increased odds of not being included in a CPP.

TECLA-an innovative technical approach for prostate cancer registries.

Objective: To present a code-driven, electronic database for patients TrEated with robotic-assisted radiCaL prostAtectomy (TECLA), developed at Innlandet Hospital (IH), Trust, Norway, for research, local quality control and to deliver data to the National Cancer Registry of Norway (CRN). Clinical data are directly extracted from the structured documentation in the electronic medical record (EMR).Materials and methods: The urological department at IH treats about 200 patients with robotic-assisted radical prostatectomy (RARP) annually. All consenting patients registered with the procedure code for RARP are included in TECLA. Clinical data are obtained automatically from the EMR, by structured forms. Patient-reported outcome and experience measures (PROMs and PREMs) are filled in by the patients on an iPad or a smartphone.Results: The basic construct of TECLA is presented. From August 2017 to June 2018, 200 men were treated with RARP, of which 182 (91%) provided consent for inclusion in the register. Of these, 97% completed the PROM survey before treatment and 91% at 3 months follow-up. PREMs were completed by 78%. All clinical variables for the hospital stay and for the 6-week follow-up were more than 95% complete.Conclusion: This entirely electronic surgical quality register is easy to use, both for patients and clinicians, and has a high capture rate. The data collection is linked to the clinicians' workflow, without double data entry, so entering data does not add any extra work. The register design can be used by other hospitals for various surgical procedures.

Prostate Cancer Diagnostics Using a Combination of the Stockholm3 Blood Test and Multiparametric Magnetic Resonance Imaging.

BACKGROUND: More specific diagnostic for prostate cancer is needed to decrease overdetection and number of diagnostic procedures. OBJECTIVE: To assess the performance of combining a blood-based biomarker panel and magnetic resonance imaging (MRI)-targeted biopsies for prostate cancer detection. DESIGN, SETTING, AND PARTICIPANTS: We used a prospective, multicenter, paired diagnostic study design. A total of 532 men aged 45-74 yr referred for prostate cancer workup were included during 2016-2017. INTERVENTION: Participants underwent blood sampling for analysis of the Stockholm3 test including protein biomarkers, genetic polymorphisms, and clinical variables; 1.5 T MRI; systematic prostate biopsies; and MRI-targeted biopsies to lesions with Prostate Imaging Reporting and Data System version 2 ≥3. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The main outcome was numbers of detected prostate cancer characterized by grade group (GG) and the number of performed biopsies using relative sensitivity (RS). RESULTS AND LIMITATIONS: Median prostate-specific antigen was 6.3 ng/ml, and mean age was 63.9 yr. Targeted and systematic biopsies detected 170 and 162 GG ≥2 tumors, respectively (RS 1.05; 95% confidence interval [CI] 0.96-1.14). Compared with performing systematic biopsies on all men, performing targeted and systematic biopsies only on men with >10% risk of GG ≥2 cancer, as predicted by the Stockholm3 test, required 62% (95% CI 58-66) of the biopsy procedures and detected 58% (95% CI 48-70) of GG 1 disease, with increased sensitivity for GG ≥2 detection (RS 1.10; 95% CI 1.02-1.17). Performing only targeted biopsies in men with elevated Stockholm3 test altered these results only slightly. Compared with performing systematic and targeted biopsies on all men, performing this only for men with an elevated Stockholm3 test decreased detection of GG ≥2 cancer slightly (RS 0.92; 95% CI 0.88-0.95). Limitations include lacking knowledge of true disease prevalence. CONCLUSIONS: These findings provide evidence that strategies combining the blood-based Stockholm3 test and MRI-targeted biopsies can be used to inform biopsy decision making. PATIENT SUMMARY: In this study, 532 men coming for prostate cancer workup underwent blood sampling, and both traditional and magnetic resonance imaging/fusion-guided prostate biopsies. We report that performing targeted biopsies only in men with an elevated risk as assessed by the Stockholm3 test saved biopsies, decreased overdetection, and maintained the number of detected high-grade cancers.

Bladder cancer survival: Women better off in the long run.

AIM: Mortality among patients with bladder cancer is usually reported to be higher for women than men, but how the risk differs and why remain largely unexplained. We also described gender-specific differences in survival for patients with bladder cancer and estimated to what extent they can be explained by differences in T-stage distribution at the first diagnosis. METHODS: The present study comprised all 15,129 new cases of histologically verified invasive and non-invasive urothelial carcinoma of the urinary bladder diagnosed between 1997 and 2011 as registered in the Cancer Registry of Norway. Gender-specific excess mortality risk rates and risk ratios were calculated based on a flexible parametric relative survival model adjusting for T-stage and age, allowing the effect of gender to vary over time. We also present gender-specific relative survival curves for different T-stage patterns adjusted for age. RESULTS: Risk rates were significantly higher for women than men up to 2 years after bladder cancer diagnosis, particularly for muscle-invasive cancers. Thereafter, risk rates appeared to be higher in men. Adverse T-Stage distribution in women explained half of the unfavourable survival difference in female patients 2 years after diagnosis. CONCLUSION: The common view of worse bladder cancer prognosis in women than in men needs to be revised. Norwegian women have a less favourable prognosis solely within the first 2 years after diagnosis, particularly when diagnosed with a muscle-invasive tumour; parts of this discrepancy can be attributed to more severe initial diagnoses in women.

Species Level Description of the Human Ileal Bacterial Microbiota.

The small bowel is responsible for most of the body's nutritional uptake and for the development of intestinal and systemic tolerance towards microbes. Nevertheless, the human small bowel microbiota has remained poorly characterized, mainly owing to sampling difficulties. Sample collection directly from the distal ileum was performed during radical cystectomy with urinary diversion. Material from the ileal mucosa were analysed using massive parallel sequencing of the 16S rRNA gene. Samples from 27 Caucasian patients were included. In total 280 unique Operational Taxonomic Units were identified, whereof 229 could be assigned to a species or a species group. The most frequently detected bacteria belonged to the genera Streptococcus, Granulicatella, Actinomyces, Solobacterium, Rothia, Gemella and TM7(G-1). Among these, the most abundant species were typically streptococci within the mitis and sanguinis groups, Streptococcus salivarius, Rothia mucilaginosa and Actinomyces from the A. meyeri/odontolyticus group. The amounts of Proteobacteria and strict anaerobes were low. The microbiota of the distal part of the human ileum is oral-like and strikingly different from the colonic microbiota. Although our patient population is elderly and hospitalized with a high prevalence of chronic conditions, our results provide new and valuable insights into a lesser explored part of the human intestinal ecosystem.

High Norwegian prostate cancer mortality: evidence of over-reporting.

OBJECTIVE: This study aimed to determine the level of misattribution of prostate cancer deaths in Norway based on the county of Vestfold in the years 2009-2014. MATERIALS AND METHODS: The study included 328 patients registered as dead from prostate cancer (PCD; part I of death certificate), 126 patients with prostate cancer as other significant condition at death (OCD; part II of death certificate) and 310 patients who died with a diagnosis of prostate cancer not registered on the death certificate (PC-DCneg) in Vestfold County in 2009-2014. The complete cohort with patients' names and dates of birth was provided by the Norwegian Institute of Public Health and the Norwegian Cancer Registry. The true cause of death of all patients was evaluated based on patient journals. RESULTS: Over-reporting of prostate cancer deaths in the PCD group was 33% while under-reporting in the OCD and PC-DCneg groups was 19% and 5%, respectively. The correlation between registered and observed causes of death was 0.81 (95% confidence interval 0.78-0.83). Misattribution of prostate cancer deaths increased significantly with patient age and decreasing Gleason score. CONCLUSIONS: Prostate cancer mortality statistics in Norway are relatively accurate for patients aged <75 years at death. However, overall accuracy of cause of death assignment is significantly reduced by misattribution among older patients (> 75 years), who represent the large majority of prostate cancer deaths. Over-reporting of prostate cancer deaths among elderly people may not be an exclusively Norwegian phenomenon and may affect prostate cancer mortality statistics in other countries.