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In 1994, the United States approved the Prostate-Specific Antigen (PSA) test as a screening tool for prostate cancer. It did so despite the test's inherent weakness: not being prostate cancer specific. Subsequent randomized trials yielded conflicting results as to its benefits. Medical guideline organizations are concerned that PSA screening results in the diagnosis and treatment of clinically indolent prostate cancer. Nevertheless, PSA screening is prevalent in North America and Europe with PSA screening increasing in other regions. We provide a critical review of the major factors that led to the prevalence of PSA screening in the United States despite the debate about its benefits. Public advocacy in favor of the test and failure of the medical community to appreciate its inherent weakness led to widespread adoption. These factors persist today. Other countries need to carefully analyze the utility of the PSA test before adopting it. [ABSTRACT FROM AUTHOR]

Currently, prostate cancer (PCa) poses a global risk to the well-being of males. Over the past fewyears, the utilization of prostate-specific antigen (PSA) screening has become prevalent in the identification and management of PCa, which has promoted a large number of patients with advanced PCa to receive timely treatment and reduce the mortality. Nevertheless, the utilization of PSA in PCa screening has sparked debate, and certain research has validated the potential for overdiagnosis and overtreatment associated with PSA screening. Hence, in order to decrease the mortality rate of PCa patients and prevent unnecessary diagnosis and treatment, it is crucial to carefully choose the suitable population and strategy for PSA screening in PCa. In this systematic review, the clinical studies on PSA screening for the diagnosis and treatment of PCa were thoroughly examined. The review also delved into the effects and mechanisms of PSA screening on the prognosis of PCa patients, examined the factors contributing to overdiagnosis and overtreatment, and put forth strategies for optimization. The objective of this research is to offer valuable recommendations regarding the utilization of PSA screening for the detection and management of PCa. [ABSTRACT FROM AUTHOR]

Purpose: It can be challenging to research aspects of people's health behaviour, attitudes, and emotions due to the sensitive nature of these topics. We aimed to develop a novel methodology for discussing sensitive health topics, and explore the effectiveness in focus groups using prostate cancer and screening as an example. Method: We developed a fictitious case and employed it as a projective technique in focus groups on prostate cancer and screening. The participants were men and their partners who lived in Denmark. Results: The technique encouraged emotional and cognitive openness in focus group discussions about the risk of prostate cancer, the benefits and harms of screening, and decision-making about screening. It appeared that using the fictitious case allowed the participants to personally distance themselves from the topic, project emotions onto the case, and thereby openly talk about their emotions. Conclusion: This article presents a methodological contribution to communication about sensitive topics in focus groups, using prostate cancer screening as an example. Further refinement of the methodology is needed to enable participants to transfer improvements in knowledge to their own decision about screening. [ABSTRACT FROM AUTHOR]

Purpose It can be challenging to research aspects of people’s health behaviour, attitudes, and emotions due to the sensitive nature of these topics. We aimed to develop a novel methodology for discussing sensitive health topics, and explore the effectiveness in focus groups using prostate cancer and screening as an example. Method We developed a fictitious case and employed it as a projective technique in focus groups on prostate cancer and screening. The participants were men and their partners who lived in Denmark. Results The technique encouraged emotional and cognitive openness in focus group discussions about the risk of prostate cancer, the benefits and harms of screening, and decision-making about screening. It appeared that using the fictitious case allowed the participants to personally distance themselves from the topic, project emotions onto the case, and thereby openly talk about their emotions. Conclusion This article presents a methodological contribution to communication about sensitive topics in focus groups, using prostate cancer screening as an example. Further refinement of the methodology is needed to enable participants to transfer improvements in knowledge to their own decision about screening.

Simple Summary: Prostate cancer (PC) is the most common male cancer, and the numbers of new cases increased hugely when prostate-specific antigen (PSA) testing became commonplace. The consequence was that the diagnostic age shifted toward younger men with less-advanced PC. Such changes are known to improve cancer survival, and in the Nordic countries, the 5-year survival for PC increased from about 60% to 90%; however, since testing stabilized, this improvement has slowed, and the 5-year survival had reached 95% by the year 2020. By analyzing survival in different periods after diagnosis, we observed that the most critical time for death was between years 1 and 5, assumably because of metastatic deaths. Some metastases are difficult to detect at diagnosis, and some arise later in the course of the disease. For continued survival, improvements in early diagnosis and more effective treatment will be required. Background: The incidence of prostate cancer (PC) increased vastly as a result of prostate-specific antigen (PSA) testing. Survival in PC improved in the PSA-testing era, but changes in clinical presentation have hampered the interpretation of the underlying causes. Design: We analyzed survival trends in PC using data from the NORDCAN database for Denmark (DK), Finland (FI), Norway (NO) and Sweden (SE) by analyzing 1-, 5- and 10-year relative survival and conditional relative survival over the course of 50 years (1971–2020). Results: In the pre-PSA era, survival improved in FI and SE and improved marginally in NO but not in DK. PSA testing began toward the end of the 1980s; 5-year survival increased by approximately 30%, and 10-year survival improved even more. Conditional survival from years 6 to 10 (5 years) was better than conditional survival from years 2 to 5 (4 years), but by 2010, this difference disappeared in countries other than DK. Survival in the first year after diagnosis approached 100%; by year 5, it was 95%; and by year 10, it was 90% in the best countries, NO and SE. Conclusions: In spite of advances in diagnostics and treatment, further attention is required to improve PC survival. [ABSTRACT FROM AUTHOR]

Abstract Background Prostate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it. Purpose The purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer. Methods Two hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers. Discussion Shared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general. Innovation and overall impact Given the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term.

Any effective screening program must satisfy 2 criteria: 1) the test must identify clinically significant disease earlier than its clinical presentation, and 2) a treatment must be available that will alter the natural history of the disease. The controversy surrounding PSA testing that has raged since 1991 centers on these 2 points. Screening and treatment trials published during the past 3 decades have provided critical insights into our understanding of the natural history of PSA identified cancers and the impact of treatment. This in turn raises questions concerning the mechanism of prostate cancer mortality reduction. This essay reflects on the mechanisms of disease progression and the implications for future screening and treatment efforts. [ABSTRACT FROM AUTHOR]

Toshihiro Saito,1 Shuichi Komatsubara,2 Noboru Hara,3 Tsutomu Nishiyama,3 Akiyoshi Katagiri,4 Fumio Ishizaki,5 Akihiko Hatano,6 Takeshi Komeyama,7 Shugo Hanyu,8 Masahiro Terunuma,9 Tomoyuki Imai,10 Hideto Go,11 Hiroaki Iida,12 Shigenori Kurumada,13 Shunsuke Yamaguchi,4,14 Keisuke Takeda,5,15 Takashi Ando,14,15 Tatsuhiko Hoshii,5 Takashi Kasahara,5 Yoshihiko Tomita5 1Department of Urology, Niigata Cancer Center Hospital, Niigata, Japan; 2Department of Urology, Niigata Minami Hospital, Niigata, Japan; 3Department of Urology, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Minamiuonuma, Japan; 4Department of Urology, Niigata Prefectural Central Hospital, Joetsu, Japan; 5Department of Renal and Urinary Pathology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan; 6Department of Urology, Niigata Prefectural Shibata Hospital, Shibata, Japan; 7Department of Urology, Nagaoka Red Cross Hospital, Nagaoka, Japan; 8Department of Urology, Kashiwazaki General Hospital and Medical Center, Kashiwazaki, Japan; 9Department of Urology, Nagaoka Chuo General Hospital, Nagaoka, Japan; 10Department of Urology, Niigata City General Hospital, Niigata, Japan; 11Department of Urology, Niigata Saiseikai Sanjo Hospital, Sanjo, Japan; 12Department of Urology, Joetsu General Hospital, Joetsu, Japan; 13Department of Urology, Saiseikai Niigata Hospital, Niigata, Japan; 14Department of Urology, Tachikawa General Hospital, Nagaoka, Japan; 15Department of Urology, Murakami General Hospital, Murakami, JapanCorrespondence: Toshihiro SaitoDepartment of Urology, Niigata Cancer Center Hospital, 2-15-3 Kawagishi-cho, Niigata, 951-8566, JapanTel +81-25-266-5111Fax +81-25-233-3849Email urotoshi@niigata-cc.jpPurpose: This study aims to investigate the utility of prostate-specific antigen (PSA) screening by conducting an all-case survey of newly diagnosed prostate cancer patients at Niigata Prefecture, Japan.Patients and Methods: Depending on whether patients were subjected to screening, information was prospectively collected on all prostate cancer patients newly diagnosed between October 1, 2019, and September 30, 2020, at all institutions in Niigata Prefecture where urologists performing prostate biopsy routinely work and differences in clinical parameters were investigated.Results: PSA was measured in 478 out of 1332 patients (35.8%) as part of a community health screening. The rate of metastatic carcinoma (M1) in all patients was 14.9%. When patients were divided into three categories of population-based screening (community health screening and workplace health screening), opportunistic screening (PSA measurements at complete medical check-ups or on patient request), and testing triggered by clinical symptoms or findings, the proportion of metastatic cancer was 4.5%, 3.7%, and 30.6%, respectively, demonstrating that the number of distant metastases was significantly lesser in all patients who underwent screening.Conclusion: The one-year all-case survey of newly diagnosed prostate cancer patients demonstrated that PSA screening significantly contributed to the early diagnosis of current prostate cancer in Japan.Keywords: prostate cancer, PSA screening, population-based screening, opportunistic screening, one-year all-case survey

Background: Prostate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it.Purpose: The purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer.Methods: Two hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers.Discussion: Shared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general.Innovation and Overall Impact: Given the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term. [ABSTRACT FROM AUTHOR]

After 2008 and 2012 USPSTF recommendations against PSA screening, studies revealed a decline in screening rates and trend towards more advanced disease at presentation. After revision of this recommendation in 2017, PSA screening guidelines remain inconsistent and controversy still exists about its clinical utility. We seek to better understand the knowledge of medical trainees regarding this fundamental controversy and gain better insight into what they are being taught regarding this topic. Participants were medical students (n = 66) and residents (n = 60) from a single institution. REDCap software was used for informed consent, survey distribution, and data collection. Variables measured included PSA clinical knowledge, awareness of the PSA guideline changes, and attitudes, confidence, and viewpoints on use of PSA screening in clinical practice. More than 60% of medical trainees reported little or no knowledge of PSA screening guidelines. Although residents reported more knowledge than medical students, actual assessed knowledge of PSA screening did not differ between groups. Trainees reported receiving education primarily from other healthcare professionals and didactics, with some self-learning online. Though confidence was low overall, residents were more confident than medical students in discussing PSA screening with patients. The majority of respondents wanted more information about PSA testing, with medical students particularly interested in diagnosis/detection, treatment, and survival. Overall, opinions towards PSA testing as an aid were generally positive. Better education about the current PSA screening guidelines for medical trainees is imperative, particularly given that shared decision-making is of great importance when counseling patients on cancer screening. [ABSTRACT FROM AUTHOR]

Introduction: Congruent with most guideline publishers, the Canadian Urological Association (CUA) recommends shared decision-making (SDM) on PSA screening (PSAS) for prostate cancer (PCa) following a discussion of its benefits and harms. However, there are limited data on how the general male population feels about these topics., Methods: A survey was completed by 906 male-identifying participants (age > 18) recruited via Amazon Mechanical Turk (MTurk), which is a crowdsourcing platform providing minimal compensation. Participants answered questions regarding demographics (15), personal/family history (9), PCa/PSA knowledge (41), and opinions regarding PSAS (45)., Results: The median age was 38.2 (SD = 12.0), with 22% reporting a family history of PCa and 20% reporting personally undergoing PSAS. Although most participants had heard of PCa (85%) and that they could be screened for it (81%), they generally did not feel knowledgeable about PCa or PSAS guidelines. Most want to talk to their clinician about PCa and PSAS (74%) and are supportive of SDM (48%) or patient-centered decision-making (25%). In general, participants thought PSAS was still worthwhile, even if it led to additional testing or side effects. Similarly, participants thought higher-risk patients should be screened earlier ( p < 0.001). A number of misconceptions were evident in the responses., Conclusions: Men approaching the age of PSAS do not feel knowledgeable about PCa or PSAS and want their clinician to discuss these topics with them. The majority believe in PSAS and would like to undergo this screening following SDM. Clinicians also have a role in correcting common misconceptions about PCa.

Abstract Background The introduction of multiparametric magnetic resonance imaging (mpMRI) and MRI‐guided biopsy has improved the diagnosis of prostate cancer. However, it remains uncertain whether it is cost‐effective, especially in a population‐based screening strategy. Methods We used a micro‐simulation model to assess the cost‐effectiveness of an MRI‐based prostate cancer screening in comparison to the classical prostate‐specific antigen (PSA) screening, at a population level. The test sensitivity parameters for the mpMRI and MRI‐guided biopsy, grade misclassification rates, utility estimates, and the unit costs of different interventions were obtained from literature. We assumed the same screening attendance rate and biopsy compliance rate for both strategies. A probabilistic sensitivity analysis, consisting of 1000 model runs, was performed to estimate a mean incremental cost‐effectiveness ratio (ICER) and assess uncertainty. A €20,000 willingness‐to‐pay (WTP) threshold per quality‐adjusted life year (QALY) gained, and a discounting rate of 3.5% was considered in the analysis. Results The MRI‐based screening improved the life‐years (LY) and QALYs gained by 3.5 and 3, respectively, in comparison to the classical screening pathway. Based on the probabilistic sensitivity analyses, the MRI screening pathway leads to total discounted mean incremental costs of €15,413 (95% confidence interval (CI) of €14,556–€16,272) compared to the classical screening pathway. The corresponding discounted mean incremental QALYs gained was 1.36 (95% CI of 1.31–1.40), resulting in a mean ICER of €11,355 per QALY gained. At a WTP threshold of €20,000, the MRI screening pathway has about 84% chance to be more cost‐effective than the classical screening pathway. Conclusions For triennial screening from age 55–64, incorporation of mpMRI as a reflex test after a positive PSA test result with a subsequent MRI‐guided biopsy has a high probability to be more cost‐effective as compared with the classical prostate cancer screening pathway.

The PSA test was introduced into clinical practice in the 1980's and quickly became widely used worldwide as a method of PSA screening for prostate cancer. The effectiveness of PSA screening in reducing cancer mortality was demonstrated in the European Randomized Study of Screening for Prostate Cancer trial (ERSPC trial), which is currently considered to be the most valid randomized controlled trial. A sub-analysis of that study also showed a 40% reduction in the risk of metastasis. As for the efficiency of screening, it was confirmed that NNI (number of persons needed to invite) was superior to that of gastric cancer, colorectal cancer, lung cancer, and breast cancer, which are the target cancers for cancer screening in Japan, and it was also shown to be cost-effective by QALY and ICER, which are indices combining QOL and screening efficiency. It is important for urologists to deal with the problem of "overdiagnosis and overtreatment" caused by the widespread use of screening by promoting active surveillance. [ABSTRACT FROM AUTHOR]

Background: Population-based prostate-specific antigen (PSA) screening is effective for reducing prostate cancer (PCa)-related mortality rates. In this study, we assessed biopsy-proven maximum cancer core length (MCCL) and maximum cancer diameter on magnetic resonance imaging (MRI; MCDM) in prostate biopsy and multiparametric MRI (mp-MRI) by PCa detection. Methods: We retrospectively assessed 214 male PCa patients and 187 PCa patients with Prostate Imaging Reporting and Data System version 2 (PI-RADS) category 3–5 lesions in pre-biopsy mp-MRI and targeted biopsy characteristics. The mean biopsy-proven MCCL and MCDM were compared among three PSA screening groups, namely the population-based PSA screening (PBS), opportunistic PSA screening (OPS), and symptomatic outpatient PSA examination (SOP) groups. Results: The median age and PSA value of the 214 participants were 75 years and 7.9 ng/mL, respectively. In the PBS, OPS, and SOP groups, the median ages were 73, 76, and 76 years, respectively (p = 0.046); PSA values were 7.2, 9.5, and 11.5 ng/mL, respectively (p < 0.001); and biopsy-proven MCCL and MCDM were significantly increased to 7, 10, and 14 mm (p < 0.001) and to 11, 15, and 17 mm (p < 0.001), respectively. In the 187 PCa patients with PI-RADS category 3–5 lesions on mp-MRI, MCDM were 11, 14, and 17 mm (p < 0.001), respectively. Conclusions: The biopsy-proven MCCL and MCDM were significantly smaller in the PBS and OPS groups than in the SOP group, which suggests that PSA screening detected PCa earlier than in symptomatic patients. PSA screening with MRI could objectively lead to earlier diagnosis based on tumor size. [ABSTRACT FROM AUTHOR]

Background: The role of prostate-specific antigen (PSA) testing in prostate cancer (PCa) screening has evolved over recent decades with multiple randomized controlled trials (RCTs) spurring guideline changes. At present, controversy exists due to the indolent nature of many prostate cancers and associated risks of overdiagnosis and overtreatment. This review examines major RCTs evaluating PSA screening to inform clinical practices., Methods and Materials: We summarize findings from primary RCTs investigating PSA screening's impact on PCa mortality and incidence: the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, the European Randomized Study of Screening for Prostate Cancer (ERSPC), and the Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP)., Results: The PLCO Trial randomized men to annual PSA and DRE screening or usual care, reporting no significant difference in PCa mortality between groups at 17 years (RR 0.93, [95% CI: 0.81-1.08]), yet significantly increased detection and concomitant decreased detection in Gleason 6 (RR 1.17, [95% CI: 1.11-1.23]) and 8-10 disease (RR 0.89, [95% CI: 0.80-0.99]) in the screening group, respectively. The ESPRC Trial randomized men across seven European countries to PSA screening every 2-4 years or usual care, noting a 20% reduction in PCa mortality at 9 years (RR 0.81, [95% CI: 0.65-0.98]) and significant decrease in metastatic disease at 12 years (RR 0.70, [95% CI: 0.60-0.82]). The CAP Trial assessed a single PSA screening test's impact on PCa mortality yielding no significant difference in PCa mortality at 10 years (RR 0.96, [95% CI: 0.85-1.08]). Limitations amongst studies included high contamination between study arms and low compliance with study protocols., Conclusions: While the CAP and initial PLCO trials showed no significant reduction in PCa mortality, the ERSPC demonstrated a 21% reduction at 13 years, with further benefits at extended follow-up. Differences in outcomes are attributed to variations in trial design, contamination, adherence rates, and PSA thresholds. Future studies are needed focus on optimizing screening intervals, targeting high-risk populations, and incorporating non-invasive diagnostic tools to improve screening efficacy and reduce associated harms., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Over the past decade, despite the controversies surrounding prostate cancer screening, significant refinements have improved its application. PSA screening, although it has been questioned, appears to confer a mortality benefit and remains the most effective way to identify the possible presence of prostate cancer. Methods to improve the specificity of PSA screening and limit overdiagnosis of indolent cancers, including risk-stratified screening regimens, are currently being utilized. Certain imaging modalities, such as multiparametric MRI, have proven to be excellent adjuncts providing improved risk stratification and the ability for targeted biopsies; however, concerns over variability in interpretation and generalizability persist. A number of novel biomarkers have become available with nearly all demonstrating the ability to improve upon the specificity of PSA screening; however, optimal timing, direct comparisons, and usefulness in conjunction with imaging modalities remain to be elucidated. With the improvement in testing options and recognition of the risk/benefit ratio for men undergoing screening for prostate cancer, the increasing role of shared decision making in the process is emphasized. [ABSTRACT FROM AUTHOR]

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In the early twenty-first century, societies around the world are facing the paradoxal epidemic development of PCa as a non-communicable disease. PCa is the most frequently diagnosed cancer for men in several countries such as the USA. Permanently improving diagnostics and treatments in the PCa management causes an impressive divergence between, on one hand, permanently increasing numbers of diagnosed PCa cases and, on the other hand, stable or even slightly decreasing mortality rates. Still, aspects listed below are waiting for innovate solutions in the context of predictive approaches, targeted prevention and personalisation of medical care (PPPM / 3PM). PCa belongs to the cancer types with the highest incidence worldwide. Corresponding economic burden is enormous. Moreover, the costs of treating PCa are currently increasing more quickly than those of any other cancer. Implementing individualised patient profiles and adapted treatment algorithms would make currently too heterogeneous landscape of PCa treatment costs more transparent providing clear "road map" for the cost saving. PCa is a systemic multi-factorial disease. Consequently, predictive diagnostics by liquid biopsy analysis is instrumental for the disease prediction, targeted prevention and curative treatments at early stages. The incidence of metastasising PCa is rapidly increasing particularly in younger populations. Exemplified by trends observed in the USA, prognosis is that the annual burden will increase by over 40% in 2025. To this end, one of the evident deficits is the reactive character of medical services currently provided to populations. Innovative screening programmes might be useful to identify persons in suboptimal health conditions before the clinical onset of metastasising PCa. Strong predisposition to systemic hypoxic conditions and ischemic lesions (e.g. characteristic for individuals with Flammer syndrome phenotype) and low-grade inflammation might be indicative for specific phenotyping and genotyping in metastasising PCa screening and disease management. Predictive liquid biopsy tests for CTC enumeration and their molecular characterisation are considered to be useful for secondary prevention of metastatic disease in PCa patients. Particular rapidly increasing PCa incidence rates are characteristic for adolescents and young adults aged 15–40 years. Patients with early onset prostate cancer pose unique challenges; multi-factorial risks for these trends are proposed. Consequently, multi-level diagnostics including phenotyping and multi-omics are considered to be the most appropriate tool for the risk assessment, prediction and prognosis. Accumulating evidence suggests that early onset prostate cancer is a distinct phenotype from both aetiological and clinical perspectives deserving particular attention from view point of 3P medical approaches. [ABSTRACT FROM AUTHOR]

Objective: To assess the influence of the 2012 US Preventive Services Task Force (USPSTF) recommendation against prostate‐specific antigen (PSA)‐based screening on oncological and functional outcomes following robot‐assisted laparoscopic prostatectomy (RALP). Materials and Methods: We retrospectively analysed patients who underwent RALP between 2008 and 2018 with a minimum of 12‐month follow‐up from a prospectively collected institutional review board‐approved database. The impact of the USPSTF recommendation against PSA screening on our surgical outcomes was assessed using a logistic regression model using two groups comprising patients treated before/after the USPSTF statement and indicating time trends for each successive year. Results: The mean preoperative PSA increased from 6.0 to 7.4 ng/mL after the USPSTF recommendation. We detected statistically significant time‐trend changes after 2012, including an increase in the positive slope of Gleason ≥3 + 4 or ≥pT3 disease. We detected a fall in bilateral full nerve‐sparing and an increase in partial nerve‐sparing. The total positive surgical margin (PSM) rate increased after the USPSTF recommendation; however, PSM rates pertinent to each pathological stage did not change significantly after 2012. There was a significant negative trend change in the postoperative 12‐month continence and potency rates, indicating a breakpoint in functional outcomes after 2012. We detected a 1.7‐fold increase in 12‐month biochemical recurrence (BCR) rates. The 12‐month BCR, potency and continence rates were maintained in young (<55 years) patients with a Sexual Health Inventory for Men score >22 and low‐volume disease. Conclusion: Since the USPSTF's recommendation in 2012, we have seen a significant increase in the incidence of high‐risk disease that has forced us to modify our approach to the procedure and the grade of nerve‐sparing used, leading to a wider resection, in order to reduce PSMs. This has led to a decrease in postoperative functional recovery. Patients with favourable characteristics had good outcomes before and after the USPSTF's recommendation, implying that the quality of surgery did not change over time. [ABSTRACT FROM AUTHOR]

Objective: To investigate the optimal age for the baseline serum prostate-specific antigen (PSA) test and for repeat screening and its economic burden in a single center in China. Materials and Methods: 35,533 men with PSA screening were retrospectively enrolled in this study. Follow-ups were conducted in 1,586 men with PSA >4 ng/mL, and receiver-operating characteristic (ROC) curves were employed to investigate the optimal cutoffs. Results: ROC analysis indicated that the optimal age for initial PSA screening was 57.5 years (AUC = 0.84), 62.5 years (AUC = 0.902), 60.5 years (AUC = 0.909), and 61.5 years (AUC = 0.890) for individuals with PSA >4 and >10 ng/mL, a diagnosis of prostate cancer (PCa), and clinically significant PCa defined as the focus events, respectively. For Chinese men aged 50–59, 60–69, and >70 years, the initial PSA levels of 1.305 ng/mL (AUC = 0.699), 1.975 ng/mL (AUC = 0.711), and 2.740 ng/mL (AUC = 0.720) might have a PSA velocity >0.75 ng/mL per year during the follow-up. In addition, the total cost amounts to CNY 13,609,260 in these cases, but only 60 of the 35,533 (0.17%) men gained benefit from PSA screening. Conclusion: In our opinion, the optimal starting age for initial PSA testing was 57.5 years. The necessity for repeat screening should be based on the first PSA level depending on age. A cost--benefit analysis should be included in population-based screening. [ABSTRACT FROM AUTHOR]

Background: We sought to determine the extent to which US Preventive Services Task Force (USPSTF) 2012 Grade D recommendations against prostate-specific antigen screening may have impacted recent prostate cancer disease incidence patterns in the United States across stage, National Comprehensive Cancer Network (NCCN) risk groups, and age groups.Methods: SEER*Stat version 8.3.4 was used to calculate annual prostate cancer incidence rates from 2010 to 2015 for men aged ≥50 years according to American Joint Committee on Cancer stage at diagnosis (localized vs metastatic), NCCN risk group (low vs unfavorable [intermediate or high-risk]), and age group (50-74 years vs ≥75 years). Age-adjusted incidences per 100,000 persons with corresponding year-by-year incidence ratios (IRs) were calculated using the 2000 US Census population.Results: From 2010 to 2015, the incidence (per 100,000 persons) of localized prostate cancer decreased from 195.4 to 131.9 (Ptrend  < .001) and from 189.0 to 123.4 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. The largest relative year-by-year decline occurred between 2011 and 2012 in NCCN low-risk disease (IR, 0.77 [0.75-0.79, P < .0001] and IR 0.68 [0.62-0.74, P < .0001] for men aged 50-74 and ≥75 years, respectively). From 2010-2015, the incidence of metastatic disease increased from 6.2 to 7.1 (Ptrend  < .001) and from 16.8 to 22.6 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively.Conclusions: This report illustrates recent prostate cancer "reverse migration" away from indolent disease and toward more aggressive disease beginning in 2012. The incidence of localized disease declined across age groups from 2012 to 2015, with the greatest relative declines occurring in low-risk disease. Additionally, the incidence of distant metastatic disease increased gradually throughout the study period. [ABSTRACT FROM AUTHOR]

Background: There is conflicting evidence about the association between prostate cancer and Lower Urinary Tract Symptoms (LUTS). We aimed to describe the prevalence of LUTS and its association with prostate cancer risk. Methods: We studied the association between International Prostate Symptom Score (IPSS) and prostate cancer in a population-based sample of men (n = 45,595) aged 50–69 years from the Stockholm3 study. Men with PSA ≥3 ng/ml (n = 4579) underwent systematic prostate biopsies. We used the International Society of Urological Pathology Gleason Grading (ISUP grade) and performed regression analysis for risk of any cancer (n = 1797), ISUP grade ≥2 (n = 840) and advanced cancer, defined as ISUP grade ≥3 or cT ≥3 (n = 353). Results: 74.6% of all men had no or mild LUTS (IPSS ≤7) and 3.2% had severe LUTS (IPSS >19). Men with any, ISUP grade ≥2 or advanced cancer had lower median IPSS compared to men with benign biopsy (any cancer: 4 (IQR 2–9); ISUP grade ≥2: 4 (2–8); advanced cancer: 4 (2–8); benign biopsy: 6 (3–11); p < 0.05). IPSS was not associated with increased risk of cancer in multivariate analyses (OR (any cancer) 0.97; 95% CI 0.96–0.98; OR (ISUP grade ≥2) 0.97; 95% CI 0.96–0.99; OR (advanced cancer) 0.99; 95% CI 0.99–1.01). Conclusions: Three-quarters of men aged 50–69 years report no or mild LUTS. Our data do not support any clinically meaningful association between LUTS and prostate cancer. Specifically, men with advanced prostate cancer did not exhibit more urinary symptoms than men without cancer. [ABSTRACT FROM AUTHOR]

Purpose: It can be challenging to research aspects of people's health behaviour, attitudes, and emotions due to the sensitive nature of these topics. We aimed to develop a novel methodology for discussing sensitive health topics, and explore the effectiveness in focus groups using prostate cancer and screening as an example., Method: We developed a fictitious case and employed it as a projective technique in focus groups on prostate cancer and screening. The participants were men and their partners who lived in Denmark., Results: The technique encouraged emotional and cognitive openness in focus group discussions about the risk of prostate cancer, the benefits and harms of screening, and decision-making about screening. It appeared that using the fictitious case allowed the participants to personally distance themselves from the topic, project emotions onto the case, and thereby openly talk about their emotions., Conclusion: This article presents a methodological contribution to communication about sensitive topics in focus groups, using prostate cancer screening as an example. Further refinement of the methodology is needed to enable participants to transfer improvements in knowledge to their own decision about screening.

Objectives: To examine trends in online search behaviours related to prostate cancer on a national and regional scale using a dominant major search engine. Materials and Methods: Google Trends was queried using the terms 'prostate cancer', 'prostate‐specific antigen' (PSA), and 'prostate biopsy' between January 2004 and January 2019. Search volume index (SVI), a measure of relative search volume on Google, was obtained for all terms and examined by region and time period: pre‐US Preventive Services Task Force (USPSTF) Grade D draft recommendation on PSA screening; during the active Grade D recommendation; and after publication of the recent Grade C draft recommendation. Results: Online interest in PSA screening differed by time period (P < 0.01). The SVI for PSA screening was greater pre‐Grade D draft recommendation (82.7) compared to during the recommendation (74.5), while the SVI for PSA screening was higher post‐Grade C draft recommendation (90.4) compared to both prior time periods. Similar results were observed for prostate biopsy and prostate cancer searches. At the US state level, online interest in prostate cancer was highest in South Carolina (SVI 100) and lowest in Hawaii (SVI 64). For prostate cancer treatment options, online interest in cryotherapy, prostatectomy and prostate cancer surgery overall increased, while searches for active surveillance, external beam radiation, brachytherapy and high‐intensity focused ultrasonography remained stable. Conclusion: Online interest in prostate cancer has changed over time, particularly in accordance with USPSTF screening guidelines. Google Trends may be a useful tool in tracking public interest in prostate cancer screening, diagnosis, and treatment, especially as it relates to major shifts in practice guidelines. [ABSTRACT FROM AUTHOR]

The European Randomized study of Screening for Prostate Cancer (ERSPC) has shown a 20% relative reduction in prostate cancer mortality after 16 yr [rate ratio (RR) 0.80], but centers varied by attendance, screen interval, biopsy compliance, contamination in the control arm, and treatments. We used a microsimulation model, calibrated to the ERSPC individual-level data, to predict influence of study features on the results. The relative reduction in prostate cancer mortality would have been somewhat larger with improved study features: increased attendance (90% attendance in all volunteer-based and 70% in all population-based centers, resulting in RR 0.77), a 2-yr screen interval (RR 0.75), and an 80% biopsy compliance (RR 0.79). The RR would have been substantially lower with a 30% attendance (RR 0.92), 40% biopsy compliance (RR 0.90), or 100% contamination (RR 0.85). The variations in results by trial center may reflect differences in study design and performance and results of our simulations highlight the effect of quality indicators in prostate-specific antigen screening in different settings. We evaluated the effect of various features of prostate-specific antigen (PSA) screening on its effectiveness. The compliance to PSA testing and those having a biopsy after an elevated PSA substantially influence the prostate cancer mortality. The prostate cancer mortality reduction found in the European Randomized study of Screening for Prostate Cancer (ERSPC) is close to what would have been expected when all centers would have performed as the best performing center. [ABSTRACT FROM AUTHOR]

Rima Tinawi-Aljundi,1 Shannon T Knuth,2 Michael Gildea,2 Joshua Khal,2 Jason Hafron,1 Kenneth Kernen,1 Robert Di Loreto,1 Joan Aurich-Costa2 1Pathology and Research Department, Michigan Institute of Urology, St Clair Shores, MI, USA; 2Research and Development, Cellay, Inc., Cambridge, MA, USA Purpose: The ability to test for and detect prostate cancer with minimal invasiveness has the potential to reduce unnecessary prostate biopsies. This study was conducted as part of a clinical investigation for the development of an OligoFISH® probe panel for more accurate detection of prostate cancer.Materials and methods: One hundred eligible male patients undergoing transrectal ultrasound biopsies were enrolled in the study. After undergoing digital rectal examination with pressure, voided urine was collected in sufficient volume to prepare at least two slides using ThinPrep. Probe panels were tested on the slides, and 500 cells were scored when possible. From the 100 patients recruited, 85 had more than 300 cells scored and were included in the clinical performance calculations.Results: Chromosomes Y, 7, 10, 20, 6, 8, 16, and 18 were polysomic in most prostate carcinoma cases. Of these eight chromosomes, chromosomes 7, 16, 18, and 20 were identified as having the highest clinical performance as a fluorescence in situ hybridization test and used to manufacture the fluorescence in situ hybridization probe panels. The OligoFISH® probes performed with 100% analytical specificity. When the OligoFISH® probes were compared with the biopsy results for each individual, the test results highly correlated with positive and negative prostate biopsy pathology findings, supporting their high specificity and accuracy. Probes for chromosomes 7, 16, 18, and 20 showed in the receiver operator characteristics analysis an area under the curve of 0.83, with an accuracy of 81% in predicting the biopsy result.Conclusion: This investigation demonstrates the ease of use with high specificity, high predictive value, and accuracy in identifying prostate cancer in voided urine after digital rectal examination with pressure. The test is likely to have positive impact on clinical practice and advance approaches to the detection of prostate cancer. Further evaluation is warranted. Keywords: prostate cancer detection, OligoFISH®, oncology, PSA screening

Purpose: The recently developed Medical Maximizer-Minimizer Scale (MMS) assesses individual differences in preferences for active v. passive medical treatment. We hypothesized that men’s maximizing-minimizing preferences might have relevance in the case of prostate-specific antigen (PSA) screening, since there is considerable variability in men’s preference for being screened even among men who are informed that harm is more likely than benefit. The current research examined whether MMS preferences predict how men respond to didactic information and narrative stories about PSA screening. Design: US men 40+ years old (N = 1208) participated in an online survey. Men viewed information about PSA screening in 3 phases and provided their preference for screening after each phase. Phase 1 described what PSA screening is. Phase 2 added didactic information about screening risks and benefits. Phase 3 added narrative stories; men were randomized to receive stories about 1) physical harm, 2) emotional harm, 3) overdiagnosis, or 4) all 3 stories. Participants also completed the validated MMS. Results: After receiving basic information, 76.8% of men wanted PSA screening. After receiving information about risks and benefits, 54.8% wanted screening (a significant reduction, P < 0.001). Men who changed their preferences were significantly more likely to be minimizers than maximizers; most men with maximizing tendencies wanted screening after both the didactic information and narratives, whereas most men with minimizing tendencies did not want the test after receiving information. Conclusions: Men who prefer a more minimizing approach to medicine are more responsive to evidence supporting limiting or forgoing screening than men who prefer a maximizing approach. [ABSTRACT FROM AUTHOR]

To compare prostate cancer (PCa) characteristics diagnosed by prostate biopsy (Pbx) in the 3 years before and after the 2012 United States Preventive Services Task Force (USPSTF) recommendations for PCa screening, we completed a retrospective comparative analysis of 402 sequential PCa patients diagnosed from 2010 to 2012 (3 years) with 552 PCa patients diagnosed from 2015 to 2017 (3 years). Data was collected on patient age, race, total number of biopsies performed, prostate specific antigen (PSA), Gleason sum score (GSS), and digital rectal examination (DRE). The data was analyzed to determine whether the 2012 USPSTF screening recommendations affected PCa characteristics. Two study groups were defined, Group A and Group B, prior to and after the 2012 USPSTF screening recommendations, respectively. In Group A (pre- 2012 USPSTF recommendations), 567 patients/year underwent a Pbx versus Group B, 398 patients/year, a 30% reduction post-USPSTF. The annual positive Pbx rate for Group A is 134/year versus Group B 184/year, a 37.3% increase post-USPSTF. Group A had high-grade PCa (GSS 7-10) in 51.5% versus Group B in 60.1%, an 8.6% increase post-USPSTF. In Group B, the total number of positive biopsies was increased by 100%. This study shows that in Group B, the Pbx rate decreased by 30% but the annual PCa detection rate increased by 37%. High-grade GSS (7-10) PCa increased by 8.6%. Despite a reduction in the total number of prostate biopsies by 30%, there was a 100% increase in the total number of positive prostate biopsies. [ABSTRACT FROM AUTHOR]

Objective:Little is known about the affective implications of communicating negative information about medical tests. This research explored how affective processes – particularly the Affect Heuristic and cancer anxiety – influence the way in which people respond to such information. Design:Participants received different types of information about PSA screening for prostate cancer and magnetic resonance imaging (MRI) scans for migraine headaches. This was a 2 (Test harm information: present vs. absent) × 2 (Test benefit information: present vs. absent) × 2 (Test recommendation: present vs. absent) between-participants design. Outcome Measures:Perceived risk, perceived benefit and general attitudes towards PSA and MRI testing, cancer anxiety, preferences to receive the tests vs. not. Results:As predicted by the Affect Heuristic, test harm information reduced perceived test benefits. However, information about uncertain test benefit did not increase perceived test risks. Information about the test reduced cancer anxiety, indicating defensive coping. These variables – affect, anxiety, perceived risks and benefits – all uniquely predicted test preferences. Conclusion:Affective processes play an important role in how people respond to and interpret negative information about medical tests. Information about harms and information about the lack of benefit can both make a test seem less beneficial, and will reduce cancer anxiety as a result. [ABSTRACT FROM PUBLISHER]

Prostate-specific antigen (PSA) screening for prostate cancer remains a controversial topic, particularly in the primary care community. Our multidisciplinary prostate screening panel at Duke University Health System, USA created a nuanced PSA screening algorithm, implemented it into the Electronic Health Record of Duke Primary Care, and conducted outreach meetings with primary care practices to support its rollout. Through this project, we identified areas of concern among primary care clinicians regarding PSA screening that we structured into two major categories: ideological opposition and logistical opposition. We outlined specific concerns in each major category and described how our team responded to those concerns. As communication between primary care clinicians and prostate specialists is vital to the success and safety of PSA screening programs, we hope that describing primary care concerns and our responses to them will help other health systems thoughtfully and efficiently implement appropriate PSA screening programs moving forward. [ABSTRACT FROM AUTHOR]

Purpose: To optimize the rescreening schedule for men with low baseline prostate-specific antigen (PSA) levels, we evaluated men with baseline PSA levels of ≤1.0 ng/mL in PSA-based population screening. Methods: We enrolled 8086 men aged 55-69 years with baseline PSA levels of ≤1.0 ng/mL, who were screened annually. The relationships of baseline PSA and age with the cumulative risks and clinicopathological features of screening-detected cancer were investigated. Results: Among the 8086 participants, 28 (0.35 %) and 18 (0.22 %) were diagnosed with prostate cancer and cancer with a Gleason score (GS) of ≥7 during the observation period, respectively. The cumulative probabilities of prostate cancer at 12 years were 0.42, 1.0, 3.4, and 4.3 % in men with baseline PSA levels of 0.0-0.4, 0.5-0.6, 0.7-0.8, and 0.9-1.0 ng/mL, respectively. Those with GS of ≥7 had cumulative probabilities of 0.42, 0.73, 2.8, and 1.9 %, respectively. The cumulative probabilities of prostate cancer were significantly lower when baseline PSA levels were 0.0-0.6 ng/mL compared with 0.7-1.0 ng/mL. Prostate cancer with a GS of ≥7 was not detected during the first 10 years of screening when baseline PSA levels were 0.0-0.6 ng/mL and was not detected during the first 2 years when baseline PSA levels were 0.7-1.0 ng/mL. Conclusions: Our study demonstrated that men with baseline PSA levels of 0.0-0.6 ng/mL might benefit from longer screening intervals than those recommended in the guidelines of the Japanese Urological Association. Further investigation is needed to confirm the optimal screening interval for men with low baseline PSA levels. [ABSTRACT FROM AUTHOR]

Introduction: Selective treatment approaches for prostate cancer (PCa) are warranted given the highly varied nature of the disease and the consequences associated with definitive therapy.Materials and Methods: We present a stepwise overview of strategies optimized to not treat PCa, ranging from improved screening practices that seek to maximize the yield at initial diagnosis, as well as refinements to clinical risk prediction and the performance of active surveillance.Results: Improved adherence to screening guidelines offering simplistic, rational practice recommendations are poised to improve the performance of early detection strategies. In addition, measures to improve the quality of PCa screening would include greater integration of novel markers with higher specificity for clinically significant disease, in an effort to stem the tide of over-diagnosis and consequential overtreatment of low-grade tumors. For men diagnosed with PCa, the use of validated, multi-variable risk stratification stands to offer greater certainty in initial management choices: consideration of active surveillance for those with low-risk status, and definitive therapy for men with intermediate and high-risk features. We review the efficacy and nature of active surveillance protocols, and offer a context for refinements that may be anticipated with future study.Conclusions: The question of how best to not treat prostate cancer is often more complex than policies of universal treatment, yet is integral to minimize morbidity of over-treatment in patients with low-risk tumors. An array of refined risk stratification instruments, biomarkers, and genomic assays seek to improve the confidence both prior to, and following diagnosis. [ABSTRACT FROM AUTHOR]

Objective To assess the impact of the United States Preventive Services Task Force ( USPTSTF) recommendations on prostate-specific antigen ( PSA) testing, prostate biopsy, and prostatectomy in Australian men based on the available Medicare data. Patients and Methods Events were identified using Medicare item numbers for PSA testing (66655, 66659), prostate biopsy (37219), prostatectomy (37210), and prostatectomy with lymph node dissection (37211). The occurrences of each procedure was queried per 100 000 capita for consecutive financial years over the period 2000-2015. For each item number, reports were also generated for all Australian States. For PSA testing the data was stratified into three age groups of 45-54, 55-64, and 65-74 years. For assessing the rate of prostatectomy the capita rate values for two item numbers of prostatectomy (37210) and prostatectomy with lymph node dissection (37211) were combined. Results Steady declines in per capita incidences of all five item numbers assessed were seen for the three consecutive financial years (2013-2015) since the publication of the USPTSTF recommendation statement. These declines were seen across all Australian States. When examining the rate of PSA testing for the three age brackets 45-54, 55-64, and 65-74 years, similar trends were identified. Conclusions Since the introduction of the USPTSTF recommendation statement there has been a steady nationwide decline in per capita incidences of PSA testing, prostate biopsy, and prostatectomy based on the Australian Medicare data. Whether these declines are in the right direction toward reduction in over-diagnosis and overtreatment of clinically insignificant prostate cancer or stage migration toward more locally advanced disease due to lost opportunity in diagnosing and treating early clinically significant prostate cancer will remain to be seen. [ABSTRACT FROM AUTHOR]

The 4Kscore® Test (BioReference Laboratories, Elmwood Park, NJ) is a blood test that accurately determines the risk of aggressive prostate cancer and significantly reduces prostate biopsies and associated overdiagnosis and overtreatment of indolent cancer. A budget impact model was developed to test the hypothesis that the 4Kscore Test can improve quality of care and deliver cost savings for patients who are suspected of having prostate cancer and would otherwise undergo prostate biopsy under the current standard of care (SOC) in the United States. The direct costs (diagnosis plus treatment) utilized in the model are based on Medicare payment data and were calculated over a 1-year time horizon. The model compares SOC, in which all patients have prostate biopsy, to a "4Kscore strategy," in which the 4Kscore Test is used to guide the decision to biopsy the prostate. A set of one-way sensitivity analyses was conducted to examine the robustness of the findings. Savings of more than $169 million (15.6% of total SOC costs) were realized in the 4Kscore strategy versus SOC ($917 M versus $1,086 M, respectively) in a cohort of 100,000 patients. Sensitivity analyses demonstrated that the findings are robust. Most cost savings for the 4Kscore strategy were realized in patients who, when managed by SOC, are found to have no prostate cancer or Gleason score 6 pathology. The patients with Gleason score 6 exhibited the greatest benefits from the 4Kscore strategy, avoiding both an unnecessary prostate biopsy and subsequent overtreatment. The 4Kscore Test was shown to significantly reduce costs to the healthcare system while improving patients' quality of care. Providers and their patients suspected of having prostate cancer should consider using the 4Kscore Test prior to proceeding with prostate biopsy. [ABSTRACT FROM AUTHOR]

Background Prostate biopsy and postbiopsy complications represent important risks of prostate-specific antigen (PSA) screening. Although landmark randomized trials and updated guidelines have challenged routine PSA screening, it is unclear whether these publications have affected rates of biopsy or postbiopsy complications. Objective To evaluate whether publication of the 2008 and 2012 US Preventive Services Task Force (USPSTF) recommendations, the 2009 European Randomized Study of Screening for Prostate Cancer and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, or the 2013 American Urological Association (AUA) guidelines was associated with changes in rates of biopsy or postbiopsy complications, and to identify predictors of postbiopsy complications. Design, setting, and participants This quasiexperimental study used administrative claims of 5 279 315 commercially insured US men aged ≥40 yr from 2005 to 2014, of whom 104 584 underwent biopsy. Interventions Publications on PSA screening. Outcome measurements and statistical analysis Interrupted time-series analysis was used to evaluate the association of publications with rates of biopsy and 30-d complications. Logistic regression was performed to identify predictors of complications. Results and limitations From 2005 to 2014, biopsy rates fell 33% from 64.1 to 42.8 per 100 000 person-months, with immediate reductions following the 2008 USPSTF recommendations (−10.1; 95% confidence interval [CI], −17.1 to −3.0; p < 0.001), 2012 USPSTF recommendations (−13.8; 95% CI, −21.0 to −6.7; p < 0 .001), and 2013 AUA guidelines (−8.8; 95% CI, −16.7 to −0.92; p = 0.03). Concurrently, complication rates decreased 10% from 8.7 to 7.8 per 100 000 person-months, with a reduction following the 2012 USPSTF recommendations (−2.5; 95% CI, −4.5 to −0.45; p = 0.02). However, the proportion of men undergoing biopsy who experienced complications increased from 14% to 18%, driven by nonsepsis infectious complications ( p < 0.001). Predictors of complications included prior fluoroquinolone use (odds ratio [OR]: 1.27; 95% CI, 1.22–1.32; p < 0.001), anticoagulant use (OR: 1.14; 95% CI, 1.04–1.25; p = 0.004), and age ≥70 yr (OR: 1.25; 95% CI, 1.15–1.36; p < 0.001). Limitations included the retrospective design. Conclusions Although there has been an absolute reduction in rates of biopsy and 30-d complications, the relative morbidity of biopsy continues to increase . These observations suggest a need to reduce the morbidity of biopsy. Patient summary Absolute rates of biopsy and postbiopsy complications have decreased following landmark publications about prostate-specific antigen screening; however, the relative morbidity of biopsy continues to increase. [ABSTRACT FROM AUTHOR]