An assessment of Prostate Cancer Research International: Active Surveillance (PRIAS) criteria for active surveillance of clinically low-risk prostate cancer patients.
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ABSTRACT:
SUBMITTER: da Silva V
PROVIDER: S-EPMC5542829 | biostudies-other | 2017 Aug
REPOSITORIES: biostudies-other
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Project description:Importance:Active surveillance is an important option to reduce prostate cancer overtreatment, but it remains underutilized in many countries. Models from the United States show that greater use of active surveillance is important for prostate cancer screening to be cost-effective. Objectives:To perform an up-to-date, nationwide, population-based study on use of active surveillance for localized prostate cancer in Sweden. Design, Setting, and Participants:Cross-sectional study in the National Prostate Cancer Register (NPCR) of Sweden from 2009 through 2014. The NPCR has data on 98% of prostate cancers diagnosed in Sweden and has comprehensive linkages to other nationwide databases. Overall, 32?518 men with a median age of 67 years were diagnosed with favorable-risk prostate cancer, including 4693, 15?403, and 17?115 men with very-low-risk (subset of the low-risk group) (clinical stage, T1c; Gleason score, ?6; prostate-specific antigen [PSA], <10 ng/mL; PSA density <0.15 ng/mL/cm3; and <8-mm total cancer length in ?4 positive biopsy cores), low-risk (including all men in the very-low-risk group) (T1-T2; Gleason score, ?6; and PSA, <10 ng/mL), and intermediate-risk disease (T1-T2 with Gleason score, 7 and/or PSA, 10-20 ng/mL). Exposures:Diagnosis with favorable-risk prostate cancer. Main Outcomes and Measures:Utilization of active surveillance. Results:The use of active surveillance increased in men of all ages from 57% (380 of 665) to 91% (939 of 1027) for very-low-risk prostate cancer and from 40% (1159 of 2895) to 74% (1951 of 2644) for low-risk prostate cancer, with the strongest increase occurring from 2011 onward. Among men aged 50 to 59 years, 88% (211 of 240) with very-low-risk and 68% (351 of 518) with low-risk disease chose active surveillance in 2014. Use of active surveillance for intermediate-risk disease remained lower, 19% (561 of 3030) in 2014. Conclusions and Relevance:Active surveillance has become the dominant management for low-risk prostate cancer among men in Sweden, with the highest rates yet reported and almost complete uptake for very-low-risk cancer. These data should serve as a benchmark to compare the use of active surveillance for favorable-risk disease around the world.
| S-EPMC5559339 | biostudies-literature
Project description:BACKGROUND: The controversies concerning possible overtreatment of prostate cancer, highlighted by debate over PSA screening, have highlighted active surveillance (AS) as an alternative management option for appropriate men. Regional differences in the underlying prevalence of PSA testing may alter the pre-test probability for high-risk disease, which can potentially interfere with the performance of selection criteria for AS. In a multicentre study from three different countries, we examine men who were initially suitable for AS according to the Toronto and Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, that underwent radical prostatectomy (RP) in regards to:1.the proportion of pathological reclassification(Gleason score ≥7, ≥pT3 disease),2.predictors of high-risk disease,3.create a predictive model to assist with selection of men suitable for AS. METHODS: From three centres in the United Kingdom, Canada and Australia, data on men who underwent RP were retrospectively reviewed (n=2329). Multivariable logistic regression was performed to identify predictors of high-risk disease. A nomogram was generated by logistic regression analysis, and performance characterised by receiver operating characteristic curves. RESULTS: For men suitable for AS according to the Toronto (n=800) and PRIAS (410) criteria, the rates for upgrading were 50.6, 42.7%, and upstaging 17.6, 12.4%, respectively. Significant predictors of high-risk disease were:•Toronto criteria: increasing age, cT2 disease, centre of diagnosis and number of positive cores.•PRIAS criteria: increasing PSA and cT2 disease.Cambridge had a high pT3a rate (26 vs 12%). To assist selection of men in the United Kingdom for AS, from the Cambridge data, we generated a nomogram predicting high-risk features in patients who meet the Toronto criteria (AUC of 0.72). CONCLUSION: The proportion of pathological reclassification in our cohort was higher than previously reported. Care must be used when applying the AS criteria generated from one population to another. With more stringent selection criteria, there is less reclassification but also fewer men who may benefit from AS.
| S-EPMC3493756 | biostudies-other
Project description:We assessed the effect of age, health status and patient preferences on outcomes of surgery vs active surveillance for low risk prostate cancer.We used Monte Carlo simulation of Markov models of the life courses of 200,000 men diagnosed with low risk prostate cancer and treated with surveillance or radical prostatectomy to calculate quality adjusted life expectancy, life expectancy, prostate cancer specific mortality and years of treatment side effects, with model parameters derived from the literature. We simulated outcomes for men 50 to 75 years old with poor, average or excellent health status (50%, 100% and 150% of average life expectancy, respectively). Sensitivity of outcomes to uncertainties in model parameters was tested.For 65-year-old men in average health, surgery resulted in 0.3 additional years of life expectancy, 1.6 additional years of impotence or incontinence and a 4.9% decrease in prostate cancer specific mortality compared to surveillance, for a net difference of 0.05 fewer quality adjusted life years. Increased age and poorer baseline health status favored surveillance. With greater than 95% probability, surveillance resulted in net benefits compared to surgery for age older than 74, 67 and 54 years for men in excellent, average and poor health, respectively. Patient preferences toward life under surveillance, biochemical recurrence of disease, treatment side effects and future discount rate affected optimal management choice.Older men and men in poor health are likely to have better quality adjusted life expectancy with active surveillance. However, specific individual preferences impact optimal choices and should be a primary consideration in shared decision making.
| S-EPMC3952430 | biostudies-other
Project description:Men on active surveillance (AS) face repeated biopsies. Most biopsy specimens will not show disease progression or change management. Such biopsies do not contribute to patient management and are potentially morbid and costly.To use a contemporary AS prospective trial to develop a tool to predict AS biopsy outcomes.Biopsy samples (median: 2; range: 2-9 per patient) from 859 men participating in the Canary Prostate Active Surveillance Study and with Gleason 6 prostate cancer (median follow-up: 35.8 mo; range: 3.0-148.7 mo) were analyzed.Logistic regression was used to predict progression, defined as an increase in Gleason score from ?6 to ?7 or increase in percentage of cores positive for cancer from <34% to ?34%. Fivefold internal cross-validation was performed to evaluate the area under the receiver operating characteristic curve (AUC).Statistically significant risk factors for progression on biopsy were prostate-specific antigen (odds ratio [OR]: 1.045; 95% confidence interval [CI], 1.028-1.063), percentage of cores positive for cancer on most recent biopsy (OR: 1.401; 95% CI, 1.301-1.508), and history of at least one prior negative biopsy (OR: 0.524; 95% CI, 0.417-0.659). A multivariable predictive model incorporating these factors plus age and number of months since last biopsy achieved an AUC of 72.4%.A combination of readily available clinical measures can stratify patients considering AS prostate biopsy. Risk of progression or upgrade can be estimated and incorporated into clinical practice.The Canary-Early Detection Research Network Active Surveillance Biopsy Risk Calculator, an online tool, can be used to guide patient decision making regarding follow-up prostate biopsy.
| S-EPMC4583313 | biostudies-literature
Project description:ImportanceActive surveillance (AS) is now recognized as the preferred management option for most low-risk prostate cancers to minimize risks of overtreatment. Despite increasing use of AS in the US, wide regional variability has been observed, and these regional variations in contemporary practice have not been well described.ObjectiveTo explore variations between county and Surveillance, Epidemiology, and End Results (SEER) regions in AS in the US.Design, setting, and participantsA cohort study using the SEER Prostate with Watchful Waiting (WW) database linked to the County Area Health Resource File for detailed county-level demographics and physician distribution data was conducted from January 2010 to December 2015. Analysis was performed in October 2020. A total of 79 825 men with clinically localized, low-risk prostate cancer eligible for AS or WW were included.ExposuresMultiple patient-, county-, and SEER region-level factors, including age, year of diagnosis, county-level densities of urologists, radiation oncologists, primary care physicians, and SEER registry region.Main outcomes and measuresUse of AS or WW as the initial reported treatment strategy were noted. Hierarchical mixed-effect logistic regression models were used to evaluate clustered random regional variation on use of AS or WW. Temporal trends by year in proportions of initial treatment type, as well as county-level local variation, were also estimated.ResultsOf 79 825 men (mean [SD] age, 62.8 [7.6] years, 11 292 [14.1%] non-Hispanic Black, 7506 [9.4%] Hispanic) with low-risk prostate cancer, the mean annualized percent increase in AS rates from 2010 to 2015 ranged from 6.3% in New Mexico to 81.0% in New Jersey. Differences across SEER regions accounted for 17% of the total variation in AS. Increasing age (51-60 years: odds ratio [OR], 1.33; 95% CI, 1.21-1.46; 61-70 years: OR, 1.86; 95% CI, 1.70-2.04; 71-80 years: OR, 2.26; 95% CI, 2.05-2.50) was associated with greater odds of AS. Hispanic ethnicity (OR, 0.79; 95% CI, 0.74-0.85), T category (OR, 0.79; 95% CI, 0.73-0.84), and Medicaid enrollment (OR, 0.73; 95% CI, 0.66-0.81) were associated with lower odds of AS. Black race, county-level socioeconomic factors (household income, educational level, and city type), and specialist densities were not associated with AS use.Conclusions and relevanceIn this US cohort study based on the SEER-WW database, although the use of AS increased, considerable practice variation appeared to be associated with geographic location, but use of AS was not associated with Black race, specialty professional density, or socioeconomic factors. This small area variation underlies the broader national trends in AS practice and may inform policies aimed at continuing to affect risk-appropriate care for men throughout the US.
| S-EPMC7770559 | biostudies-literature
Project description:PurposeActive surveillance represents a strategy to address the overtreatment of prostate cancer, yet uncertainty regarding individual patient outcomes remains a concern. We evaluated outcomes in a prospective multicenter study of active surveillance.Materials and methodsWe studied 905 men in the prospective Canary PASS enrolled between 2008 and 2013. We collected clinical data at study entry and at prespecified intervals, and determined associations with adverse reclassification, defined as increased Gleason grade or greater cancer volume on followup biopsy. We also evaluated the relationships of clinical parameters with pathology findings in participants who underwent surgery after a period of active surveillance.ResultsAt a median followup of 28 months 24% of participants experienced adverse reclassification, of whom 53% underwent treatment while 31% continued on active surveillance. Overall 19% of participants received treatment, 68% with adverse reclassification, while 32% opted for treatment without disease reclassification. In multivariate Cox proportional hazards modeling the percent of biopsy cores with cancer, body mass index and prostate specific antigen density were associated with adverse reclassification (p=0.01, 0.04, 0.04, respectively). Of 103 participants subsequently treated with radical prostatectomy 34% had adverse pathology, defined as primary pattern 4-5 or nonorgan confined disease, including 2 with positive lymph nodes, with no significant relationship between risk category at diagnosis and findings at surgery (p=0.76).ConclusionsMost men remain on active surveillance at 5 years without adverse reclassification or adverse pathology at surgery. However, clinical factors had only a modest association with disease reclassification, supporting the need for approaches that improve the prediction of this outcome.
| S-EPMC4970462 | biostudies-literature
Project description:ObjectiveTo evaluate the association of biopsy perineural invasion (PNI) with adverse pathologic findings on radical prostatectomy in patients who would have been candidates for active surveillance (AS).MethodsUsing a prospectively populated database of 3084 men who underwent open radical prostatectomy, candidates for AS by strict (Johns Hopkins) and expanded (University of Toronto) criteria were identified. The presence of adverse pathologic features at radical prostatectomy was compared between those men with and without biopsy PNI.ResultsOf 596 men who met strict criteria for AS, 16 (3%) had biopsy PNI. In the strict AS cohort, there were no differences in adverse pathologic features at radical prostatectomy between those with and without PNI. Of 1197 men who were candidates for AS by expanded criteria, 102 (9%) had biopsy PNI. Men with biopsy PNI in the expanded AS cohort were more likely to have extraprostatic extension (P < .001) and pathologic upgrading (P = .01) at prostatectomy. In addition, those with PNI had larger dominant nodules (P < .001), and cancer comprised a greater percentage of their prostate glands (P < .001). There was no difference in the proportion with a positive margin between the 2 groups (P = .77).ConclusionBiopsy PNI was rare in patients who met strict criteria for AS. Among those men who met expanded criteria, PNI was associated with adverse pathologic findings upon prostatectomy. The presence of biopsy PNI may have a role in further risk stratifying patients who meet expanded criteria for AS.
| S-EPMC5376357 | biostudies-literature
Project description:Physicians report difficulty convincing patients with prostate cancer about the merits of active surveillance (AS); as a result, a majority of patients unnecessarily choose to undergo radical treatment.To develop and evaluate a systematic approach for physicians to counsel patients with low-risk prostate cancer to increase acceptance of AS.A systematic counseling approach was developed and piloted in one clinic. Then five surgeons participated in a 1-h training session in which they learned about the approach. A total of 1003 patients with Gleason 3+3 prostate cancer were included in the study. We compared AS rates for 761 patients who were counseled over a 24-mo period before the training intervention with AS rates for 242 patients who were counseled over a 12-mo period afterwards, controlling for temporal trends and case mix.A systematic approach for communicating the merits of AS using appropriate framing techniques derived from principles studied by negotiation scholars.The rate of AS acceptance by patients for management of low-risk prostate cancer.In the pilot phase, 81 of 86 patients (94%) accepted AS after counseling by the physician who developed the counseling approach. In the subsequent study, the cohort for the training intervention comprised 1003 consecutive patients, 80% of whom met the Epstein criteria for very low-risk disease. The proportion of patients who selected AS increased from 69% before the training intervention to 81% afterwards. After adjusting for time trends and case mix, the rate of AS after the intervention was 9.1% higher (95% confidence interval -0.4% to 19.4%) than expected, a relative reduction of approximately 30% in the risk of unnecessary curative treatment.A systematic approach to counseling can be taught to physicians in a 1-h lecture. We found evidence that even this minimal intervention can decrease overtreatment. Our novel approach offers a framework to help address cancer screening-related overtreatment that occurs across medicine.In this study, we evaluated the impact of teaching physicians how to better communicate the benefits and risks of prostate cancer treatments on the willingness of patients to choose active surveillance. Decisions related to cancer are often guided by emotions and biases that lead most patients to seek radical treatment; however, we demonstrated that if discussions are framed differently, these biases can be overcome and more patients will choose active surveillance.
| S-EPMC5714298 | biostudies-literature
Project description:BackgroundThe routine clinical use of serum prostatic specific antigen (PSA) testing has allowed earlier detection of low-grade prostate cancer (PCa) with more favourable characteristics, leading to increased acceptance of management by active surveillance (AS). AS aims to avoid over treatment in men with low and intermediate-risk PCa and multiple governing bodies have described several AS protocols. This study provides a descriptive profile of the Guy's and St Thomas NHS Foundation Trust (GSTT) AS cohort as a platform for future research in AS pathways in PCa.MethodsDemographic and baseline characteristics were retrospectively collected in a database for patients at the GSTT AS clinic with prospective collection of follow-up data from 2012. Seven hundred eighty-eight men being monitored at GSTT with histologically confirmed intermediate-risk PCa, at least 1 follow-up appointment and diagnostic characteristics consistent with AS criteria were included in the profile. Descriptive statistics, Kaplan-Meier survival curves and multivariable Cox proportion hazards regression models were used to characterize the cohort.DiscussionA relatively large proportion of the cohort includes men of African/Afro-Caribbean descent (22%). More frequent use of magnetic resonance imaging and trans-perineal biopsies at diagnosis was observed among patients diagnosed after 2012. Those who underwent trans-rectal ultrasound diagnostic biopsy received their first surveillance biopsy 20 months earlier than those who underwent trans-perineal diagnostic biopsy. At 3 years, 76.1% men remained treatment free. Predictors of treatment progression included Gleason score 3 + 4 (Hazard ratio (HR): 2.41, 95% Confidence interval (CI): 1.79-3.26) and more than 2 positive cores taken at biopsy (HR: 2.65, CI: 1.94-3.62). A decreased risk of progressing to treatment was seen among men diagnosed after 2012 (HR: 0.72, CI: 0.53-0.98).ConclusionAn organised biopsy surveillance approach, via two different AS pathways according to the patient's diagnostic method, can be seen within the GSTT cohort. Risk of patients progressing to treatment has decreased in the period since 2012 compared with the prior period with more than half of the cohort remaining treatment free at 5 years, highlighting that the fundamental aims of AS at GSTT are being met. Thus, this cohort is a good resource to investigate the AS treatment pathway.
| S-EPMC8135162 | biostudies-literature
Project description:BackgroundSeveral active surveillance (AS) criteria have been established to screen insignificant prostate cancer (insigPCa, defined as organ confined, low grade and small volume tumors confirmed by postoperative pathology). However, their comparative diagnostic performance varies. The aim of this study was to compare the diagnostic accuracy of contemporary AS criteria and validate the absolute diagnostic odds ratio (DOR) of optimal AS criteria.MethodsFirst, we searched Pubmed and performed a Bayesian network meta-analysis (NMA) to compare the diagnostic accuracy of contemporary AS criteria and obtained a relative ranking. Then, we searched Pubmed again to perform another meta-analysis to validate the absolute DOR of the top-ranked AS criteria derived from the NMA with two endpoints: insigPCa and favorable disease (defined as organ confined, low grade tumors). Subgroup and meta-regression analyses were conducted to identify any potential heterogeneity in the results. Publication bias was evaluated.ResultsSeven eligible retrospective studies with 3,336 participants were identified for the NMA. The diagnostic accuracy of AS criteria ranked from best to worst, was as follows: Epstein Criteria (EC), Yonsei criteria, Prostate Cancer Research International: Active Surveillance (PRIAS), University of Miami (UM), University of California-San Francisco (UCSF), Memorial Sloan-Kettering Cancer Center (MSKCC), and University of Toronto (UT). I2 = 50.5%, and sensitivity analysis with different insigPCa definitions supported the robustness of the results. In the subsequent meta-analysis of DOR of EC, insigPCa and favorable disease were identified as endpoints in ten and twenty-two studies, respectively. The pooled DOR for insigPCa and favorable disease were 0.44 (95%CI, 0.31-0.58) and 0.66 (95%CI, 0.61-0.71), respectively. According to a subgroup analysis, the DOR for favorable disease was significantly higher in US institutions than that in other regions. No significant heterogeneity or evidence of publication bias was identified.ConclusionsAmong the seven AS criteria evaluated in this study, EC was optimal for positively identifying insigPCa patients. The pooled diagnostic accuracy of EC was 0.44 for insigPCa and 0.66 when a more liberal endpoint, favorable disease, was used.Systematic review registration[https://www.crd.york.ac.uk/prospero/], PROSPERO [CRD42020157048].
| S-EPMC8785217 | biostudies-literature