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ARTS will be the first trial to compare anticoagulation with a direct oral anticoagulant (apixaban) versus no anticoagulation among patients undergoing intra-abdominal, gynecologic, or urologic surgery at sufficiently similar risk of deep vein thrombosis or pulmonary embolism and major bleeding.

Publisher Copyright: © 2022 The Authors Background: Despite being one of the most frequent urological procedures, the risk estimates for complications after hydrocele surgery (hydrocelectomy) are uncertain. Decision-making about hydrocelectomy involves balancing the risk of complications with efficacy of surgery—a tradeoff that critically depends on the complication risks of hydrocele surgery. Objective: To examine the 90-d risks of complications of hydrocele surgery in a large, contemporary sample. Design, setting, and participants: We retrospectively reviewed all surgeries performed for nonrecurrent hydroceles conducted in all five Helsinki metropolitan area public hospitals from the beginning of 2010 till the end of 2018, and evaluated the complication outcomes. Outcome measurements and statistical analysis: The following outcomes were evaluated: (1) risk of moderate or severe (Clavien-Dindo II–V) hydrocele surgery complications, (2) risk of reoperation due to a surgical complication, and (3) risk of an unplanned postoperative visit to the emergency room or outpatient clinic, all within 90 d after surgery. Results and limitations: We identified 866 hydrocele operations (38 [4.3%] bilateral operations). A total of 139 (16.1%) patients had moderate or severe hydrocele surgery complications within 90 d after surgery. Of the 139 complications, 94 were (10.9% of all or 67.6% of patients with moderate or severe complications) Clavien-Dindo grade II, 43 (5.0% and 30.9%, respectively) grade III, two (0.2% and 1.4%, respectively) grade IV, and none grade V. A total of 45 patients (5.2% of all and 32.4% of those who had moderate or severe complications) required immediate reoperation due to complications. All together 219 operated patients (25.3% of all operated patients) had an unplanned visit to the emergency room. The retrospective study design limits the reliability of the results. Conclusions: Complications after hydrocele surgery are common and warrant further research. These estimates can be useful in shared decision-making between clinicians and patients. Patient summary: We investigated the complication rates after hydrocele surgery and found that complications are common after a procedure often considered minor: every ninth patient had a moderate and every 20th a severe complication. Every fourth patient had an unplanned postoperative visit to the emergency room.

Tumour associated trypsin inhibitor (TATI) is a peptide that is a marker for several tumours. TATI may also behave as an acute phase reactant in severe inflammatory disease. Overexpression of TATI predicts an unfavourable outcome for many cancers. This study aimed to evaluate the prognostic value of pre- and postoperative concentration of TATI in serum (S-TATI) of patients with renal cell carcinoma (RCC).S-TATI was determined by time resolved immunofluorometric assay in preoperative and postoperative samples that were collected from 132 RCC patients, who underwent partial or complete nephrectomy in Helsinki University Hospital from May 2005 to July 2010.Preoperative S-TATI was significantly associated with tumour stage, lymph-node involvement, metastatic stage, Chronic Kidney Disease Stage (CKD grade), and preoperative C-reactive protein level (Our data suggest that elevated postoperative S-TATI may be associated with adverse prognosis in RCC patients.

In randomized controlled trials, investigators often explore the possibility that the treatment effects differ between subgroups (eg, women vs men, old vs young, more versus less severe disease). Investigators often inappropriately claim subgroup effects (also called “effect modification” or “interaction”) when the likelihood of a true effect modification is low. Criteria for assessing the credibility of subgroup analyses, nicely summarized in a formal Instrument for Assessing the Credibility of Effect Modification Analyses (ICEMAN), include investigator postulation of a priori hypotheses with a specified direction; support from prior evidence; a low likelihood that chance explains the apparent subgroup effect; and only testing a small number of subgroup hypotheses. Patient summary Randomized clinical trials often use subgroup analyses to explore whether a treatment is more or less effective in a particular patient subgroup (eg, women vs men, old vs young). In this mini-review, we explore the common pitfalls of subgroup analyses.

After surgery of localized renal cell carcinoma, over 20% of the patients will develop distant metastases. Our aim was to develop an easy-to-use prognostic model for predicting metastasis-free survival after radical or partial nephrectomy of localized clear cell RCC. Model training was performed on 196 patients. Right-censored metastasis-free survival was analysed using LASSO-regularized Cox regression, which identified three key prediction features. The model was validated in an external cohort of 714 patients. 55 (28%) and 134 (19%) patients developed distant metastases during the median postoperative follow-up of 6.3 years (interquartile range 3.4–8.6) and 5.4 years (4.0–7.6) in the training and validation cohort, respectively. Patients were stratified into clinically meaningful risk categories using only three features: tumor size, tumor grade and microvascular invasion, and a representative nomogram and a visual prediction surface were constructed using these features in Cox proportional hazards model. Concordance indices in the training and validation cohorts were 0.755 ± 0.029 and 0.836 ± 0.015 for our novel model, which were comparable to the C-indices of the original Leibovich prediction model (0.734 ± 0.035 and 0.848 ± 0.017, respectively). Thus, the presented model retains high accuracy while requiring only three features that are routinely collected and widely available.

Background: The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality. Objective: To determine whether PSA screening decreases PCa mortality for up to 16 yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended. Design, setting, and participants: This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182 160 men, followed up until 2014 (maximum of 16 yr), with a predefined core age group of 162 389 men (55-69 yr), selected from population registry. Outcome measurements and statistical analysis: The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended. Results and limitations: The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p 20 ng/ml (9.9% compared with 4.1% in the second round, p

Background: There is a lack of detailed population-based data for renal cell carcinoma (RCC). Objectives: The study aimed to examine the contemporary changes in the clinical picture and treatment of RCC. Methods: A total of 1,719 consecutive patients living in the Helsinki metropolitan area with a solid or cystic renal mass (Bosniak 3–4) ≥10 mm were identified. Data from medical records was evaluated for clinical characteristics and treatments in the periods I (2006–2008), II (2009–2011), III (2012–2014), and IV (2015–2016). Results: The proportions of patients with comorbidities (Charlson index ≥2) and frailty (Eastern Co-operative Oncology Group classification ≥2) increased significantly during the study period. The percentage of clinical stage I patients, cystic tumors and use of needle biopsies increased significantly. Use of observation increased from 9% (I) to 32% (IV; p < 0.001). First-line oncological treatments within 6 months were given to 47% of 262 patients with metastases and ­cytoreductive nephrectomy (CN) was delivered to 54% of those patients. Conclusions: The size of renal tumors continued to decrease, while the percentage of patients with significant comorbidity or frailty increased. Active surveillance emerged as the initial strategy. Tyrosine kinase inhibitors with CN remained the primary option in patients with metastatic RCC.

Aim This study was conducted to evaluate the efficacy of surgical treatment for metastases accompanied by modern targeted therapies and to evaluate the performance of the Leuven-Udine (L.U.) prognostic groups model. Methods This retrospective analysis included 97 consecutive patients with metastatic renal cell carcinoma (mR.C.C.) who underwent surgery for metastases at Helsinki University Hospital between 2006 and 2017. The endpoints were overall survival (O.S.), cancer-specific survival (C.S.S.), recurrence-free survival (R.F.S.) and interval from diagnosis to oncological treatment. Results The median follow-up time was 46 months (interquartile range, I.Q.R. = 24-74). The estimated median O.S. was 67 months (I.Q.R. = 30-130). A radical surgical result at metastasectomy was achieved in 46 of 97 patients (47%). Of those 46 patients, 28 (61%) experienced recurrence after complete metastasectomy. Median R.F.S. after complete metastasectomy was 10 months (I.Q.R. = 3-37). Five-year O.S. was 59% for patients with complete metastasectomy and 44% for patients with non-complete metastasectomy (p = .035). The median interval from diagnosis to the initiation of targeted oncological treatment was 19 months for patients with non-complete metastasectomy and has hitherto not been reached for patients with complete metastasectomy (p = .006). A statistically significant validation of the prognostic value of the L.U. prognostic groups for predicting C.S.S. was not obtained (p = .420). Conclusions Metastasectomy is an option for selected patients with mR.C.C. Complete resection should be attempted when feasible. The data failed to support the prognostic significance of the L.U. model in patients with mR.C.C.

BackgroundTo determine the added value of preoperative prostate multiparametric MRI (mpMRI) supplementary to clinical variables and their role in predicting post prostatectomy adverse findings and biochemically recurrent cancer (BCR).MethodsAll consecutive patients treated at HUS Helsinki University Hospital with robot assisted radical prostatectomy (RALP) between 2014 and 2015 were included in the analysis. The mpMRI data, clinical variables, histopathological characteristics, and follow-up information were collected. Study end-points were adverse RALP findings: extraprostatic extension, seminal vesicle invasion, lymph node involvement, and BCR. The Memorial Sloan Kettering Cancer Center (MSKCC) nomogram, Cancer of the Prostate Risk Assessment (CAPRA) score and the Partin score were combined with any adverse findings at mpMRI. Predictive accuracy for adverse RALP findings by the regression models was estimated before and after the addition of MRI results. Logistic regression, area under curve (AUC), decision curve analyses, Kaplan-Meier survival curves and Cox proportional hazard models were used.ResultsPreoperative mpMRI data from 387 patients were available for analysis. Clinical variables alone, MSKCC nomogram or Partin tables were outperformed by models with mpMRI for the prediction of any adverse finding at RP. AUC for clinical parameters versus clinical parameters and mpMRI variables were 0.77 versus 0.82 for any adverse finding. For MSKCC nomogram versus MSKCC nomogram and mpMRI variables the AUCs were 0.71 and 0.78 for any adverse finding. For Partin tables versus Partin tables and mpMRI variables the AUCs were 0.62 and 0.73 for any adverse finding. In survival analysis, mpMRI-projected adverse RP findings stratify CAPRA and MSKCC high-risk patients into groups with distinct probability for BCR.ConclusionsPreoperative mpMRI improves the predictive value of commonly used clinical variables for pathological stage at RP and time to BCR. mpMRI is available for risk stratification prebiopsy, and should be considered as additional source of information to the standard predictive nomograms.

BACKGROUND: Multiparametric magnetic resonance imaging (MRI), with or without MRI‐targeted biopsy, is an alternative test to systematic transrectal ultrasonography‐guided biopsy in men suspected of having prostate cancer. At present, evidence on which test to use is insufficient to inform detailed evidence‐based decision‐making. OBJECTIVES: To determine the diagnostic accuracy of the index tests MRI only, MRI‐targeted biopsy, the MRI pathway (MRI with or without MRI‐targeted biopsy) and systematic biopsy as compared to template‐guided biopsy as the reference standard in detecting clinically significant prostate cancer as the target condition, defined as International Society of Urological Pathology (ISUP) grade 2 or higher. Secondary target conditions were the detection of grade 1 and grade 3 or higher‐grade prostate cancer, and a potential change in the number of biopsy procedures. SEARCH METHODS: We performed a comprehensive systematic literature search up to 31 July 2018. We searched CENTRAL, MEDLINE, Embase, eight other databases and one trials register. SELECTION CRITERIA: We considered for inclusion any cross‐sectional study if it investigated one or more index tests verified by the reference standard, or if it investigated the agreement between the MRI pathway and systematic biopsy, both performed in the same men. We included only studies on men who were biopsy naïve or who previously had a negative biopsy (or a mix of both). Studies involving MRI had to report on both MRI‐positive and MRI‐negative men. All studies had to report on the primary target condition. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed the risk of bias using the QUADAS‐2 tool. To estimate test accuracy, we calculated sensitivity and specificity using the bivariate model. To estimate agreement between the MRI pathway and systematic biopsy, we synthesised detection ratios by performing random‐effects meta‐analyses. To estimate the proportions of participants with prostate cancer detected by only one of the index tests, we used random‐effects multinomial or binary logistic regression models. For the main comparisions, we assessed the certainty of evidence using GRADE. MAIN RESULTS: The test accuracy analyses included 18 studies overall. MRI compared to template‐guided biopsy: Based on a pooled sensitivity of 0.91 (95% confidence interval (CI): 0.83 to 0.95; 12 studies; low certainty of evidence) and a pooled specificity of 0.37 (95% CI: 0.29 to 0.46; 12 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI may result in 273 (95% CI: 249 to 285) true positives, 441 false positives (95% CI: 378 to 497), 259 true negatives (95% CI: 203 to 322) and 27 (95% CI: 15 to 51) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency. MRI‐targeted biopsy compared to template‐guided biopsy: Based on a pooled sensitivity of 0.80 (95% CI: 0.69 to 0.87; 8 studies; low certainty of evidence) and a pooled specificity of 0.94 (95% CI: 0.90 to 0.97; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI‐targeted biopsy may result in 240 (95% CI: 207 to 261) true positives, 42 (95% CI: 21 to 70) false positives, 658 (95% CI: 630 to 679) true negatives and 60 (95% CI: 39 to 93) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency. The MRI pathway compared to template‐guided biopsy: Based on a pooled sensitivity of 0.72 (95% CI: 0.60 to 0.82; 8 studies; low certainty of evidence) and a pooled specificity of 0.96 (95% CI: 0.94 to 0.98; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, the MRI pathway may result in 216 (95% CI: 180 to 246) true positives, 28 (95% CI: 14 to 42) false positives, 672 (95% CI: 658 to 686) true negatives and 84 (95% CI: 54 to 120) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations, inconsistency and imprecision. Systemic biopsy compared to template‐guided biopsy: Based on a pooled sensitivity of 0.63 (95% CI: 0.19 to 0.93; 4 studies; low certainty of evidence) and a pooled specificity of 1.00 (95% CI: 0.91 to 1.00; 4 studies; low certainty of evidence) using a baseline prevalence of 30%, systematic biopsy may result in 189 (95% CI: 57 to 279) true positives, 0 (95% CI: 0 to 63) false positives, 700 (95% CI: 637 to 700) true negatives and 111 (95% CI: 21 to 243) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency. Agreement analyses: In a mixed population of both biopsy‐naïve and prior‐negative biopsy men comparing the MRI pathway to systematic biopsy, we found a pooled detection ratio of 1.12 (95% CI: 1.02 to 1.23; 25 studies). We found pooled detection ratios of 1.44 (95% CI 1.19 to 1.75; 10 studies) in prior‐negative biopsy men and 1.05 (95% CI: 0.95 to 1.16; 20 studies) in biopsy‐naïve men. AUTHORS' CONCLUSIONS: Among the diagnostic strategies considered, the MRI pathway has the most favourable diagnostic accuracy in clinically significant prostate cancer detection. Compared to systematic biopsy, it increases the number of significant cancer detected while reducing the number of insignificant cancer diagnosed. The certainty in our findings was reduced by study limitations, specifically issues surrounding selection bias, as well as inconsistency. Based on these findings, further improvement of prostate cancer diagnostic pathways should be pursued.

Background: Diagnosing clinically significant prostate cancer (PCa) is challenging, but may be facilitated by biomarkers and multiparametric magnetic resonance imaging (MRI). Objective: To determine the association between biomarkers phosphatase and tensin homolog (PTEN) and ETS-related gene (ERG) with visible and invisible PCa lesions in MRI, and to predict biochemical recurrence (BCR) and non-organ-confined (non-OC) PCa by integrating clinical, MRI, and biomarker-related data. Design, setting, and participants: A retrospective analysis of a population-based cohort of men with PCa, who underwent preoperative MRI followed by radical prostatectomy (RP) during 2014-2015 in Helsinki University Hospital (n = 346), was conducted. A tissue microarray corresponding to the MRI-visible and MRI-invisible lesions in RP specimens was constructed and stained for PTEN and ERG. Outcome measurements and statistical analysis: Associations of PTEN and ERG with MRI-visible and MRI-invisible lesions were examined (Pearson's chi 2 test), and predictions of non-OC disease together with clinical and MRI parameters were determined (area under the receiver operating characteristic curve and logistic regression analyses). BCR prediction was analyzed by Kaplan-Meier and Cox proportional hazard analyses. Results and limitations: Patients with MRI-invisible lesions (n = 35) had less PTEN loss and ERG-positive expression compared with patients (n = 90) with MRI-visible lesions (17.2% vs 43.3% [p = 0.006]; 8.6% vs 20.0% [p = 0.125]). Patients with invisible lesions had better, but not statistically significantly improved, BCR-free survival probability in Kaplan-Meier analyses (p = 0.055). Rates of BCR (5.7% vs 21.1%; p = 0.039), extraprostatic extension (11.4% vs 44.6%; p < 0.001), seminal vesicle invasion (0% vs 21.1%; p = 0.003), and lymph node metastasis (0% vs 12.2%; p = 0.033) differed between the groups in favor of patients with MRI-invisible lesions. Biomarkers had no independent role in predicting non-OC disease or BCR. The short follow-up period was a limitation. Conclusions: PTEN loss, BCR, and non-OC RP findings were more often encountered with MRI-visible lesions. Patient summary: Magnetic resonance imaging (MRI) of the prostate misses some cancer lesions. MRI-invisible lesions seem to be less aggressive than MRI-visible lesions. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.

This study evaluated the clinical outcome of patients with renal cell carcinoma (RCC) with tumour thrombus (TT) after surgical management.In total, 142 consecutive RCC patients with TT who were operated on in Helsinki University Hospital between 2006 and 2014 were analysed. Eighty-eight (62%) of these patients had been operated on with radical intention and 54 (38%) with cytoreductive intention. A total of 73 patients (51%) received postoperative targeted therapy. The primary endpoint was cancer-specific survival (CSS).The 5 year CSS for level of involvement of TT in the renal vein, subdiaphragmatic vena cava and supradiaphragmatic vena cava was 60% (81 patients), 43% (52 patients) and 51% (nine patients), respectively (p = .42). The median CSS for lymph-node involvement was 63 months for patients with no lymph-node involvement but 10 months for patients with lymph-node involvement (p .01). The median CSS for metastasis status was 63 months for patients with no metastases compared with 18 months for patients with metastases (p .01). Among several factors examined, WHO performance status (p = .04), tumour necrosis (p = .05), presence of distant metastases (p = .04) and tumour histology (p = .05) were associated with CSS in the multivariate analysis.Operative treatment for RCC with TT is associated with good prognosis when there is no lymph-node involvement or distant metastases.

The magnetic resonance imaging/ultrasound fusion-guided biopsy (FBx) technique has gained popularity in prostate cancer (PCa) diagnostics, but little is known about its effect on patient experience.To evaluate pain, discomfort and other non-infectious complications in PCa patients undergoing either systematic 12-core transrectal ultrasound-guided biopsy (SBx) or FBx and patient willingness to undergo rebiopsy.A prospective trial of 262 male patients, 203 of whom underwent transrectal SBx and 59 FBx at Helsinki University Hospital in 2015-2016. Patients completed two questionnaires immediately after and at 30 d after biopsy.Patients reported pain and discomfort on a numeric rating scale (NRS; 0-10) immediately after biopsy. At 30 d, discomfort was measured on a scale ranging from 1 (no inconvenience) to 4 (maximal inconvenience). Other symptoms were reported dichotomously (yes/no) in both questionnaires. Mann-Whitney U, Pearson's χFor the SBx and FBx groups the median number of cores per patient was 12 and three, respectively. At 30 d, a higher proportion of patients in the SBx group had experienced pain than in the FBx group (70/203 [34%] vs 12/59 [20%]; p=0.043), whereas there was no difference in the median discomfort scores. Hematuria was less common in the FBx group (26/59 [44%] vs 140/203 [69%]; p0.001). Patients willing to undergo rebiopsy immediately post-biopsy reported lower median NRS (3.0 [interquartile range 2.0-5.0] vs 5.0 [4.3-6.0]; p0.001) and discomfort scores (4.0 [2.0-6.0] vs 7.0 [5.0-8.0]; p0.001) than those unwilling. At 30 d, less discomfort (2.0 [interquartile range 1.0-2.0] vs 2.0 [2.0-3.0]; p=0.008) and fever (6/195 [3.1%] vs 6/28 [22%]; p=0.001) were experienced by patients willing to undergo rebiopsy. The nonrandomized design was a limitation.FBx is associated with less pain and hematuria than SBx during the 30-d interval after biopsy.Magnetic resonance imaging (MRI)-targeted prostate biopsy is associated with less pain, discomfort, and blood in the urine compared to the standard ultrasound-guided procedure. Performing MRI-targeted procedures may reduce biopsy-related complications and promote adherence to recommended repeat biopsy for patients on active surveillance for prostate cancer.

Introduction This study was conducted to describe the changes in repeat multiparametric MRI (mpMRI) occurring in prostate cancer (PCa) patients during active surveillance (AS), and to study possible associations between mpMRI-related parameters in predicting prostate biopsy (Bx) Gleason score (GS) upgrading >3+3 and protocol-based treatment change (TC). Materials and methods The study cohort consisted of 76 AS patients with GS 3+3 PCa and at least two consecutive mpMRIs of the prostate performed between 2006–2015. Patients were followed according to the Prostate Cancer Research International Active Surveillance (PRIAS) protocol and an additional mpMRI. The primary end points were GS upgrading (GU) (>3+3) in protocol-based Bxs and protocol-based TC. Results Out of 76 patients, 53 (69%) had progression (PIRADS upgrade, size increase or new lesion[s]), while 18 (24%) had radiologically stable disease, and 5 (7%) had regression (PIRADS or size decrease, disappearance of lesion[s]) in repeat mpMRIs during AS. PIRADS scores of 4–5 in the initial mpMRI were associated with GU (p = 0.008) and protocol-based TC (p = 0.009). Tumour progression on repeat mpMRIs was associated with TC (p = 0.045) but not with GU (p = 1.00). PIRADS scores of 4–5 predict GU (sensitivity 0.80 [95% confidence interval (CI); 0.51–0.95, specificity 0.62 [95% CI; 0.52–0.77]) with PPV and NPV values of 0.34 (95% CI; 0.21–0.55) and 0.93 (95% CI; 0.80–0.98), respectively. Conclusion mpMRI is a useful tool not only to select but also to monitor PCa patients on AS.

Prostate cancer (PC) screening with prostate-specific antigen (PSA) has been shown to decrease PC mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC). However, in the Finnish trial, which is the largest component of the ERSPC, no statistically significant mortality reduction was observed. We investigated which had the largest impact on PC deaths in the screening arm: non-participation, interval cancers or PSA threshold. The screening (SA) and control (CA) arms comprised altogether 80,144 men. Men in the SA were screened at four-year intervals and referred to biopsy if the PSA concentration was ≥ 4.0 ng/ml, or 3.0-3.99 ng/ml with a free/total PSA ratio ≤ 16%. The median follow-up was 15.0 years. A counterfactual exclusion method was applied to estimate the effect of three subgroups in the SA: the non-participants, the screen-negative men with PSA ≥ 3.0 ng/ml and a subsequent PC diagnosis, and the men with interval PCs. The absolute risk of PC death was 0.76% in the SA and 0.85% in the CA; the observed hazard ratio (HR) was 0.89 (95% confidence interval (CI) 0.76-1.04). After correcting for non-attendance, the HR was 0.78 (0.64-0.96); predicted effect for a hypothetical PSA threshold of 3.0 ng/ml the HR was 0.88 (0.74-1.04) and after eliminating the effect of interval cancers the HR was 0.88 (0.74-1.04). Non-participating men in the SA had a high risk of PC death and a large impact on PC mortality. A hypothetical lower PSA threshold and elimination of interval cancers would have had a less pronounced effect on the screening impact.

Purpose: Screening for prostate cancer remains controversial, although ERSPC (European Randomized Study of Screening for Prostate Cancer) showed a 21% relative reduction in prostate cancer mortality. The Finnish Randomized Study of Screening for Prostate Cancer, which is the largest component of ERSPC, demonstrated a statistically nonsignificant 16% mortality benefit in a separate analysis. The purpose of this study was to estimate the degree of contamination in the control arm of the Finnish trial. Materials and Methods: Altogether 48,295 and 31,872 men were randomized to the control and screening arms, respectively. The screening period was 1996 to 2007. The extent of prostate specific antigen testing was analyzed retrospectively using laboratory databases. The incidence of T1c prostate cancer (impalpable prostate cancer detected by elevated prostate specific antigen) was determined from the national Finnish Cancer Registry. Results: Approximately 1.4% of men had undergone prostate specific antigen testing 1 to 3 years before randomization. By the first 4, 8 and 12 years of follow-up 18.1%, 47.7% and 62.7% of men in the control arm had undergone prostate specific antigen testing at least once and in the screening arm the proportions were 69.8%, 81.1% and 85.2%, respectively. The cumulative incidence of T1c prostate cancer was 6.1% in the screening arm and 4.5% in the control arm (RR 1.21, 95% CI 1.13-1.30). Conclusions: A large proportion of men in the control arm had undergone a prostate specific antigen test during the 15-year followup. Contamination is likely to dilute differences in prostate cancer mortality between the arms in the Finnish screening trial.

Key Points: Question: What is the association of decision aids vs usual care with shared decision-making in men deciding whether to undergo prostate cancer screening? Findings: This systematic review and meta-analysis of 19 randomized clinical trials comparing decision aids for prostate cancer screening (12781 men) found that decision aids are probably associated with a small reduction in decisional conflict and are possibly associated with an increase in knowledge. Decision aids are possibly not associated with whether physicians and patients discuss prostate cancer screening and are possibly not associated with actual screening decisions. Meaning: Randomized clinical trials have failed to provide compelling evidence for the use of decision aids for men contemplating prostate cancer screening that have, up to now, undergone rigorous testing to determine their outcome. Importance: US guidelines recommend that physicians engage in shared decision-making with men considering prostate cancer screening. Objective: To estimate the association of decision aids with decisional outcomes in prostate cancer screening. Data Sources: MEDLINE, Embase, PsycINFO, CINAHL, and Cochrane CENTRAL were searched from inception through June 19, 2018. Study Selection: Randomized trials comparing decision aids for prostate cancer screening with usual care. Data Extraction and Synthesis: Independent duplicate assessment of eligibility and risk of bias, rating of quality of the decision aids, random-effects meta-analysis, and Grading of Recommendations, Assessment, Development and Evaluations rating of the quality of evidence. Main Outcomes and Measures: Knowledge, decisional conflict, screening discussion, and screening choice. Results: Of 19 eligible trials (12781 men), 9 adequately concealed allocation and 8 blinded outcome assessment. Of 12 decision aids with available information, only 4 reported the likelihood of a true-negative test result, and 3 presented the likelihood of false-negative test results or the next step if the screening test result was negative. Decision aids are possibly associated with improvement in knowledge (risk ratio, 1.38; 95% CI, 1.09-1.73; I-2=67%; risk difference, 12.1; low quality), are probably associated with a small decrease in decisional conflict (mean difference on a 100-point scale, -4.19; 95% CI, -7.06 to -1.33; I-2=75%; moderate quality), and are possibly not associated with whether physicians and patients discuss prostate cancer screening (risk ratio, 1.12; 95% CI, 0.90-1.39; I-2=60%; low quality) or with men's decision to undergo prostate cancer screening (risk ratio, 0.95; 95% CI, 0.88-1.03; I-2=36%; low quality). Conclusions and Relevance: The results of this study provide moderate-quality evidence that decision aids compared with usual care are associated with a small decrease in decisional conflict and low-quality evidence that they are associated with an increase in knowledge but not with whether physicians and patients discussed prostate cancer screening or with screening choice. Results suggest that further progress in facilitating effective shared decision-making may require decision aids that not only provide education to patients but are specifically targeted to promote shared decision-making in the patient-physician encounter. This systematic review and meta-analysis of 19 randomized clinical trials estimates the association of decision aids with decisional outcomes in prostate cancer screening.