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European guidelines recommend that well-informed men at elevated risk of having prostate cancer (PCa) should be offered prostate-specific antigen (PSA) testing with risk-stratified follow-up. The Swedish National Board of Health and Welfare recommends against screening for PCa but supports regional implementation of organised prostate cancer testing (OPT).To report the process for designing and implementing OPT programmes.Population-based OPT programmes in two Swedish regions, designed to include men aged between 50 and 74 yr, launched in September 2020 for 50-yr-old men.The number of men invited, the participation rate, and the numbers of magnetic resonance imaging (MRI) scans, urological visits, and biopsies from September 2020 to June 2021 were recorded.Two Swedish regions co-designed an OPT programme with a risk-stratified diagnostic algorithm based on prostate-specific antigen (PSA), PSA density, MRI findings, and age. An automated administrative system was developed on a nationwide web-based platform. Invitation letters and test results are automatically generated and sent out by post. Men with PSA ≥3ng/ml, a suspicious MRI lesion, and/or PSA density ≥0.15 ng/ml/cmWe designed and implemented a framework for OPT with a high grade of automation. The framework and organisational experiences may be of value for others who plan a programme for early detection of PCa.We describe the implementation of an organised testing programme for early detection of prostate cancer in two Swedish regions. This model is the first of its kind and may serve as a template for similar programmes.

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The long-term outcomes among men with prostate cancer (PC) whose disease is managed with active surveillance (AS) remains unknown.To develop a simulation model with a 30-year follow-up for men with PC managed with AS.In this cohort study, a state transition model was created using data from Prostate Cancer data Base Sweden (PCBaSe) on 23 655 men diagnosed with PC and managed with deferred treatment to estimate treatment trajectories. A simulation was performed with 100 000 men in each combination of age at diagnosis, Charlson Comorbidity Index, and PC risk with a follow-up of 30 years.Death from PC and death from other causes were estimated, and the proportion of time without active PC treatment was assessed until date of death or age 85 years.This study included 23 655 men from PCBaSe with a median age at diagnosis of 69 years (IQR, 64-74 years). Of these, 16 177 men underwent active surveillance for PC and 7478 underwent watchful waiting. The proportion of men who were diagnosed at age 55 years and died of PC before age 85 years was 9% for very low-risk PC, 13% for low-risk PC, and 15% for intermediate-risk PC. Among men with a Charlson Comorbidity Index of 0 who were diagnosed at age 70 years, the corresponding percentages were 3%, 6%, and 7%, respectively. The mean proportion of remaining life-years without active PC treatment for men diagnosed at age 55 years was 12 of 25 years (48%) for very low-risk PC, 9 of 25 years (36%) for low-risk PC, and 7 of 25 (29%) for intermediate-risk PC. For men aged 70 years, the corresponding numbers were 10 of 13 years (77%), 9 of 13 years (66%), and 8 of 13 years (60%), respectively. Men with intermediate-risk PC who were younger than 60 years at diagnosis had a high risk of PC death (12%-15%) and fewer remaining life-years without active PC treatment (29%-33%). In contrast, men with low-risk PC who were older than 65 years at diagnosis had a lower risk of PC death (3%-5%) and more remaining life-years without active PC treatment (62%-77%).The findings of this Swedish cohort study suggest that active surveillance may be a safe strategy for disease management among men with PC who were older than 65 years at diagnosis.

Enzalutamide and abiraterone acetate plus prednisone (AAP) have similar efficacy in metastatic castration-resistant prostate cancer (mCRPC), but different mechanisms of action. The aim was to compare patient-reported health-related quality of life (HRQoL) in men treated with enzalutamide vs AAP for mCRPC. We systematically reviewed the literature in June 2020 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Patient-reported outcomes (PROs) until the last follow-up were summarised in a narrative synthesis. Short-term changes (12 weeks) in HRQoL, measured by the Functional Assessment of Cancer Therapy-Prostate total score (FACT-P), were compared between treatment groups and were analysed for enzalutamide and AAP in separate meta-analyses. Higher FACT-P scores indicate better HRQoL. Eight studies were included in the systematic review, four of which were randomised clinical trials (RCTs) eligible for the meta-analyses. The meta-analyses showed mean within-subject FACT-P changes from baseline to week 12 of −1.3 points (95% confidence interval [CI] −2.7; 0.1) for enzalutamide and 4.7 points (95% CI −0.1; 9.6) for AAP. One RCT and three non-randomised studies directly compared enzalutamide with AAP. The RCT showed better short-term HRQoL for AAP (6.8 FACT-P-points, 95% CI 1.7; 11.8) and better long-term HRQoL for AAP in men ≥75 years (7.35 FACT-P-points, 95% CI 2.59; 12.11). The non-randomised studies showed no difference in long-term HRQoL but had all a serious risk of bias. Limitations of the included studies include that the PRO in the included trials were inconsistently reported and that only one study defined the HRQoL measures in their published protocol. AAP seems to be associated with better short-term HRQoL than enzalutamide. This difference was not apparent at longer follow-up, but the long-term studies had serious risks of bias.

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.

UNLABELLED: European and American guidelines recommend abdominal computed tomography (CT) and bone scans for staging of high-risk prostate cancer (PC). To improve clinical risk stratification of nonmetastatic PC a new, five-tier risk classification system has been developed, the Cambridge Prognostic Groups (CPG), in which "high-risk" PC is divided into favourable CPG 4 and unfavourable CPG 5. We used the National Prostate Cancer Register of Sweden (NPCR) to define the rates of positive CT and bone scan findings among men with CPG 4 or 5 cancer. Among men with CPG 4 and prostate-specific antigen (PSA)

To assess the value of a first MRI examination and image-fusion-guided biopsies in men with low-risk prostate cancer who have been on active surveillance (AS) for several years with no signs of progression.All 45 participants from two centers who had not previously had an MRI were included. They had been on AS for T1c Gleason score 6 prostate cancer for 2.6 to 6.7 years and had 2 to 5 sets of systematic biopsies with a total of 1640 cores. All underwent a bi-parametric MRI, PI-RADS ≥ 3 lesions were targeted with image-fusion-guided biopsies. Primary outcome measure: detection of Gleason score ≥7 cancer.Twenty-five of the 45 men (56%) had a total of 30 suspicious MRI lesions. The lesion with the highest score was a PI-RADS 3 in 18, a PI-RADS 4 in 5 and PI-RADS 5 in 3 men. Targeted biopsies from the 30 lesions detected Gleason score 7 cancer in 6 men. Of these six cancers, four were located in the apical and one in the anterior/apical part of the prostate. A Gleason score 7 cancer was detected in 3 of 5 men with PSA density0.15 ng/ml/cmEven after several years of AS with stable PSA values and many sets of systematic biopsies, a first MRI and targeted biopsies lead to the detection of Gleason score 7 (ISUP 2 and ISUP 3) cancer in a significant proportion of men, particularly among those with a high PSA density.

Patient-reported data are important for quality assurance and improvement. Our main aim was to investigate the association between patient-reported symptoms among patients undergoing radical prostatectomy and their perceived quality of information before treatment. In this single-centre study, 235 men treated with robotic-assisted radical prostatectomy (RARP) between August 2017 and June 2019, responded to a follow-up questionnaire 20–42 months after surgery. A logistic regression analysis was performed to assess the association between patient-reported symptoms, measured with Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), and the perceived quality of information. Adverse effects were defined as a higher EPIC score at follow-up than at baseline. The majority (77%) rated the general information as good. Higher EPIC-CP at follow-up was significantly associated with lower perceived quality of information, also after adjustment for age and level of education (bivariate model OR 1.12, 95% CI 1.07; 1.16, p < 0.001 and multiple model OR 1.12 95% CI 1.08; 1.17, p < 0.001). The share who rated information as good was almost identical among those who reported more symptoms after treatment and those who reported less symptoms (78.3% and 79.2%). Consequently, adverse effects could not explain the results. Our findings suggest a need for improvement of preoperative communication.

Objective To investigate whether post-transplantation immunosuppression negatively affects prostate cancer outcomes in male kidney transplant recipients. Patients and methods We used the Swedish Renal Register and the National Prostate Cancer Register to identify all kidney transplantation recipients diagnosed with prostate cancer in Sweden 1998-2016. After linking these registers with Prostate Cancer Database Sweden (PCBaSe), a case-control study was designed to compare time period and risk category-specific probabilities of a prostate cancer diagnosis amongst kidney transplantation recipients versus the male general population. The registers did not include information about the specific immunosuppression agent used in all transplantation recipients. Data from PCBaSe were used to compare prostate cancer characteristics at diagnosis and survival for patients with prostate cancer with versus without a kidney transplant. Propensity score matching, Cox regression analysis and Fisher's exact test were used and 95% confidence intervals (CIs) calculated. Results Almost half of the 133 kidney transplantation recipients were transplanted before the mid-1990s, when PSA testing became common. The transplant recipients were not more likely than age-matched control men to be diagnosed with any (odds ratio [OR] 0.84, 95% CI 0.70-0.99) or high-risk or metastatic prostate cancer (OR 0.84, 95% CI 0.62-1.13). None of the ORs for the different categories of prostate cancer increased with time since transplantation. Cancer characteristics at the time of diagnosis and cancer-specific survival were similar amongst transplant recipients and the control group of 665 men diagnosed with prostate cancer without a kidney transplant. Conclusions This Swedish nationwide, register-based study gave no indication that immunosuppression after kidney transplantation increases the risk of prostate cancer or adversely affects prostate cancer outcomes. The study suggests that men with untreated low-grade prostate cancer can be accepted for transplantation.

Objectives To test whether using disease prognosis can inform a rational approach to active surveillance (AS) for early prostate cancer. Patients and methods We previously developed the Cambridge Prognostics Groups (CPG) classification, a five-tiered model that uses prostate-specific antigen (PSA), Grade Group and Stage to predict cancer survival outcomes. We applied the CPG model to a UK and a Swedish prostate cancer cohort to test differences in prostate cancer mortality (PCM) in men managed conservatively or by upfront treatment in CPG2 and 3 (which subdivides the intermediate-risk classification) vs CPG1 (low-risk). We then applied the CPG model to a contemporary UK AS cohort, which was optimally characterised at baseline for disease burden, to identify predictors of true prognostic progression. Results were re-tested in an external AS cohort from Spain. Results In a UK cohort (n = 3659) the 10-year PCM was 2.3% in CPG1, 1.5%/3.5% in treated/untreated CPG2, and 1.9%/8.6% in treated/untreated CPG3. In the Swedish cohort (n = 27 942) the10-year PCM was 1.0% in CPG1, 2.2%/2.7% in treated/untreated CPG2, and 6.1%/12.5% in treated/untreated CPG3. We then tested using progression to CPG3 as a hard endpoint in a modern AS cohort (n = 133). During follow-up (median 3.5 years) only 6% (eight of 133) progressed to CPG3. Predictors of progression were a PSA density ≥0.15 ng/mL/mL and CPG2 at diagnosis. Progression occurred in 1%, 8% and 21% of men with neither factor, only one, or both, respectively. In an independent Spanish AS cohort (n = 143) the corresponding rates were 3%, 10% and 14%, respectively. Conclusion Using disease prognosis allows a rational approach to inclusion criteria, discontinuation triggers and risk-stratified management in AS.

Background PREDICT Prostate is an endorsed prognostic model that provides individualised long-term prostate cancer-specific and overall survival estimates. The model, derived from UK data, estimates potential treatment benefit on overall survival. In this study, we externally validated the model in a large independent dataset and compared performance to existing models and within treatment groups. Methods Men with non-metastatic prostate cancer and prostate-specific antigen (PSA) Prostate for prostate cancer-specific mortality (PCSM) and all-cause mortality (ACM). Discrimination was assessed using Harrell’s concordance (c)-index in R. Calibration was evaluated using cumulative available follow-up in Stata (TX, USA). Results Overall discrimination of PREDICT Prostate was good with c-indices of 0.85 (95% CI 0.85–0.86) for PCSM and 0.79 (95% CI 0.79–0.80) for ACM. Overall calibration of the model was excellent with 25,925 deaths predicted and 25,849 deaths observed. Within the conservative management and radical treatment groups, c-indices for 15-year PCSM were 0.81 and 0.78, respectively. Calibration also remained good within treatment groups. The discrimination of PREDICT Prostate significantly outperformed the EAU, NCCN and CAPRA scores for both PCSM and ACM within this cohort overall. A key limitation is the use of retrospective cohort data. Conclusions This large external validation demonstrates that PREDICT Prostate is a robust and generalisable model to aid clinical decision-making.

Objectives The aim of this study was to assess the incidence of infection after transrectal prostate biopsy (TRbx). Secondary objectives were to describe infection characteristics, antibiotic resistance patterns, ICD-10 coding, and costs. Methods TRbx carried out at the hospitals of Angelholm and Helsingborg, Scania, Sweden, between October 2017 and March 2019, were identified based on the NOMESCO Classification of Surgical Procedures code for TRbx, TKE00. All patients received per oral antibiotic prophylaxis, usually 750 mg ciprofloxacin at biopsy. Other preventative measures were not used. Medical care within 30 days of the biopsy was evaluated through a manual retrospective medical chart review. Data on patient and infection characteristics were collected. The costs of infections causing hospitalization were estimated. Results After 36 (5.4%) of 670 biopsies, the patient developed post-biopsy infection within 30 days after TRbx. Twenty-six patients (3.9%) required hospitalization for an average of 6 days, at an estimated direct cost of USD 9174 (EUR 8031) per patient. Nine patients (1.3%) had a complicated infection leading to intensive care, multiple hospitalizations or emergency department visits. The inpatient care episodes for the 26 hospitalized patients were categorized with 15 different ICD-codes. In 6 episodes no ICD-code related to infection was used. Conclusions In this study, we found an infection rate of 5.4% after TRbx; 3.9% of the patients were hospitalized for a post-TRbx infection and 1.3% had complicated infections. A specific ICD code for post-TRbx infections would facilitate evaluation and monitoring of this common, costly, and sometimes serious complication.

Transrectal prostate biopsy (TRbx) transfers colonic bacteria into prostatic tissue, potentially causing infectious complications, including sepsis. Our objective was to determine whether biopsy needle shape, surface properties and sampling mechanism affect the number of bacteria transferred through the colon wall, and evaluate a novel needle with improved properties.The standard Tru-Cut biopsy needle used today was evaluated for mechanisms of bacterial transfer in a pilot study. A novel Tru-Cut needle (Forsvall needle prototype) was developed. TRbx was simulated using human colons ex-vivo. Four subtypes of the prototype needle were compared with a standard Tru-Cut needle (BARD 18 G). Prototype and standard needles were used to puncture 4 different colon specimens in 10 randomized sites per colon. Needles were submerged into culture media to capture translocated bacteria. The media was cultured on blood agar and then the total amount of transferred bacteria was calculated for each needle. The primary outcome measure was the percent reduction of bacteria translocated by the prototype needles relative to the standard needle. Secondary outcome measures were the effects of tip design and coating on the percent reduction of translocated bacteria.Prototype needles reduced the number of translocated bacteria by, on average, 96.0% (95% confidence interval 93.0-97.7%;The Forsvall needle significantly reduces colonic bacterial translocation, suggesting that it could reduce infectious complications in prostate biopsy. A clinical trial has been initiated.

Transrectal prostate biopsy (TRbx) carries an increasing risk of infection. The Forsvall Needle Prototype (FNP) is a novel biopsy needle that reduces bacterial load brought across the rectum and may therefore reduce infection risk. The objective of this study was to compare biopsy length, quality and patient experience for the FNP Version 2 (FNP2) versus a standard Tru-Cut needle.We conducted a randomized, parallel-group, non-inferiority trial with twenty consecutive patients eligible for TRbx. Participants were randomized to undergo TRbx using either FNP2 or a standard Tru-Cut needle. The primary outcome was difference in mean biopsy lengths measured by the pathologist. FNP2 biopsy lengths ≤1.35 mm of the standard needle length were considered non-inferior. Secondary outcomes were biopsy length in the needle chamber and immediately after removal, biopsy quality, biopsy fragmentation, patient discomfort/pain, and complications (immediate and after 14 and 30 days).Mean pathologist-measured FNP2 biopsy length was non-inferior compared to the standard Tru-Cut needle (0.02 mm longer, 95%CI-0.73 to 0.76 mm). Biopsy length in the needle chamber and immediately after removal were also non-inferior. Biopsy quality and patient discomfort were not significantly different for the FNP2 and the standard Tru-Cut needle. Biopsy fragmentation was more common in the FNP2 group.The FNP2 biopsy needle is non-inferior to the Tru-Cut needle in terms of biopsy length and not significantly different in terms of biopsy quality and patient experience. Future studies will evaluate the Forsvall needle design's effect on post-biopsy infection risk.

The first case of COVID-19 in Sweden was diagnosed in late January 2020, the first recommendations against the spread of the virus were released in mid-March, and the peak of the first wave of the pandemic was reached in March-June. The aim of this cross-sectional study was to assess the short-term effects of the first wave of the COVID-19 pandemic on prostate cancer (PCa) diagnosis, staging, and treatment.Data in the National Prostate Cancer Register (NPCR) of Sweden on newly diagnosed PCa cases and on the number of diagnostic and therapeutic procedures performed between 18 March 2020 and 2 June 2020 were compared with those in the corresponding time periods in 2017-2019, as reported until January 31 of the year after each study period.During the study period in 2020, 36% fewer PCa cases were registered in NPCR compared with the corresponding time period in previous years: 1458 cases in 2020 vs a mean of 2285 cases in 2017-2019. The decrease in new PCa registrations was more pronounced in men above age 75 years, down 51%, than in men aged 70-75, down 37%, and in men below age 70, down 28%. There was no decrease in the number of radical prostatectomies and number of radical radiotherapy courses increased by 32%.During the peak of the first phase of the COVID-19 pandemic, the number of men diagnosed with PCa in Sweden decreased by one third compared with previous years, whereas there was no decrease in the number of curative treatments.

Background PSA density has previously been identified as a predictor of histological upgrading at radical prostatectomy in men eligible for active surveillance, but how information from pretreatment 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 Gleason Grade (GG) group 1 and pretreatment bpMRI. Methods This study included all 130 men with GG 1 cancer who between March 2014 and September 2019 had a robotic-assisted radical prostatectomy (RARP) at Innlandet Hospital Trust and a bpMRI before their diagnostic biopsy. The outcome measure was upgrading from GG 1 on biopsy to GG 2–5 in the radical prostatectomy specimen. Logistic regression models were used to explore predictors for upgrading. Odds ratios (ORs) and confidence intervals (CIs) were calculated. The association between PSA density and the probability of upgrading was assessed after stratifying by Prostate Imaging-Reporting and Data System and Reporting Datasystem (PI-RADS): PI-RADS 1–3 versus 4–5. Results Upgrading was present in 56% (73/130) of the cancers. PSA density was the only significant predictor for upgrading (OR = 1.7, 95% CI 1.2; 2.5). The probability of upgrading was higher for men with a PIRADS 1–3 than for men with PIRADS 4–5, but the difference was not statistically significant (adjusted OR 0.4, 95% CI 0.2; 1.1, p = 0.082). However, among men with PI-RADS 1–3, the probability gradually 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. Conclusion PSA density is a clinically important factor to predict upgrading from GG 1 to GG 2–5 when bpMRI shows no suspicious lesion. In men with a suspicious tumour on bpMRI (PI-RADS 4–5), the probability of an undetected GG 2–5 cancer is high regardless of the PSA density.

5021 Background: A baseline prostate-specific antigen (PSA) level in midlife is strongly associated with risk of lethal prostate cancer several decades later. In most prior studies, PSA was measured in archived blood from men participating in cohort studies unrelated to prostate cancer. In clinical practice, however, men commonly obtain a PSA test because of lower urinary tract symptoms. Here, we study the association between PSA values when a first PSA test was obtained as part of clinical care – and subsequent risks of prostate cancer diagnosis and death. Methods: The NPCC database contained laboratory results from 1995-2006 of the first (“baseline”) PSA test below 4.0 ng/mL in 157,836 men aged 40-69 years without prior prostate cancer (PCa) diagnosis. PSA strata were pre-defined: < 1, 1-1.99, 2-2.99, 3-3.99 ng/ml and analyses were split in two age groups based on a prior risk: 40-54 (“younger”) and 55-69 (“older”). Predictive accuracy was assessed with Harrell’s concordance (C) index. The Kaplan-Meier method was used to visualize risk of PCa death as reported on the death certificate by PSA strata for the two age groups. Results: Among 157,836 men with a PSA below 4.0 ng/mL, 83% had < 2.0 ng/mL. Risk of prostate cancer and death from prostate cancer were strongly associated with PSA-levels and age: Harrell’s C-index 0.75 and 0.72 for diagnosis of younger and older group, respectively and 0.72 for PCa death for both age groups. In the younger age group 196 deaths among 75,446 men (0.26%) were registered, in the older 943 deaths among 82,390 men (1.14%). The risk of PCa death in lowest (< 1) and highest (3-3.99) strata were 0.23% and 3.22%, respectively (189 deaths among 81,982 vs. 274 deaths among 8517 men). Conclusions: This population-based NPCC study shows as strong predictive impact of the different strata of the initial PSA measurement in routine clinical care as prior studies based on cryopreserved blood samples. [Table: see text]

Clinical context: Population-based screening for prostate cancer with PSA tests and systematic prostate biopsies reduces cancer-specific mortality as much as screening for breast and colorectal can...

Patient-reported experience measures (PREMs) are important to capture the patients’ voice. No such measure is routinely used for evaluation after robotic-assisted radical prostatectomy for prostate cancer. The aim of this study was to adapt the short version of the PREM questionnaire quality from the patients’ perspective (QPP), and assess the construct validity of this version. Quality from the patients’ perspective assesses 4 dimensions of quality of care. Involving discussion with user representatives, the QPP short version was adapted by adding 7 context-specific questions based on items from the Expanded Prostate Cancer Index Composite for Clinical Practice. This short version was answered on smartphone or tablet by 265 patients. We used exploratory factor analysis to assess dimensionality. For comparison with previous publications of the QPP, the analysis was repeated after mean imputation of missing values. The factor analysis identified 7 factors among the 30 analyzed items included in the analysis, explaining 64.9% of the variance. After imputation of missing, 2 factors explained 48.6% of the variance. None of these analysis captured the 4 dimensions of the QPP. Keywords PREMs, prostate cancer, perceived quality of care, construct validity This study is supported by Innlandet Hospital Trust, Norway

Enzalutamide and abiraterone acetate plus prednisone (AAP) have similar efficacy in metastatic castration-resistant prostate cancer (mCRPC), but different mechanisms of action. The aim was to compare patient-reported health-related quality of life (HRQoL) in men treated with enzalutamide vs AAP for mCRPC.We systematically reviewed the literature in June 2020 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Patient-reported outcomes (PROs) until the last follow-up were summarised in a narrative synthesis. Short-term changes (12 weeks) in HRQoL, measured by the Functional Assessment of Cancer Therapy-Prostate total score (FACT-P), were compared between treatment groups and were analysed for enzalutamide and AAP in separate meta-analyses. Higher FACT-P scores indicate better HRQoL.Eight studies were included in the systematic review, four of which were randomised clinical trials (RCTs) eligible for the meta-analyses. The meta-analyses showed mean within-subject FACT-P changes from baseline to week 12 of -1.3 points (95% confidence interval [CI] -2.7; 0.1) for enzalutamide and 4.7 points (95% CI -0.1; 9.6) for AAP. One RCT and three non-randomised studies directly compared enzalutamide with AAP. The RCT showed better short-term HRQoL for AAP (6.8 FACT-P-points, 95% CI 1.7; 11.8) and better long-term HRQoL for AAP in men ≥75 years (7.35 FACT-P-points, 95% CI 2.59; 12.11). The non-randomised studies showed no difference in long-term HRQoL but had all a serious risk of bias. Limitations of the included studies include that the PRO in the included trials were inconsistently reported and that only one study defined the HRQoL measures in their published protocol.AAP seems to be associated with better short-term HRQoL than enzalutamide. This difference was not apparent at longer follow-up, but the long-term studies had serious risks of bias.