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Thread: (C) Screening Diagnosis PSA Imaging Biopsies

  1. #121
    [#113]
    Prostate MRI, with or without MRI‐targeted biopsy, and systematic biopsy for detecting prostate cancer [2019, Review]

    Abstract

    Background
    Multiparametric magnetic resonance imaging (MRI), with or without MRI‐targeted biopsy, is an alternative test to systematic transrectal ultrasonography‐guided biopsy in men suspected of having prostate cancer. At present, evidence on which test to use is insufficient to inform detailed evidence‐based decision‐making.

    Objectives
    To determine the diagnostic accuracy of the index tests MRI only, MRI‐targeted biopsy, the MRI pathway (MRI with or without MRI‐targeted biopsy) and systematic biopsy as compared to template‐guided biopsy as the reference standard in detecting clinically significant prostate cancer as the target condition, defined as International Society of Urological Pathology (ISUP) grade 2 or higher. Secondary target conditions were the detection of grade 1 and grade 3 or higher‐grade prostate cancer, and a potential change in the number of biopsy procedures.

    Search methods
    We performed a comprehensive systematic literature search up to 31 July 2018. We searched CENTRAL, MEDLINE, Embase, eight other databases and one trials register.

    Selection criteria
    We considered for inclusion any cross‐sectional study if it investigated one or more index tests verified by the reference standard, or if it investigated the agreement between the MRI pathway and systematic biopsy, both performed in the same men. We included only studies on men who were biopsy nave or who previously had a negative biopsy (or a mix of both). Studies involving MRI had to report on both MRI‐positive and MRI‐negative men. All studies had to report on the primary target condition.

    Data collection and analysis
    Two reviewers independently extracted data and assessed the risk of bias using the QUADAS‐2 tool. To estimate test accuracy, we calculated sensitivity and specificity using the bivariate model. To estimate agreement between the MRI pathway and systematic biopsy, we synthesised detection ratios by performing random‐effects meta‐analyses. To estimate the proportions of participants with prostate cancer detected by only one of the index tests, we used random‐effects multinomial or binary logistic regression models. For the main comparisions, we assessed the certainty of evidence using GRADE.

    Main results
    The test accuracy analyses included 18 studies overall.

    MRI compared to template‐guided biopsy: Based on a pooled sensitivity of 0.91 (95% confidence interval (CI): 0.83 to 0.95; 12 studies; low certainty of evidence) and a pooled specificity of 0.37 (95% CI: 0.29 to 0.46; 12 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI may result in 273 (95% CI: 249 to 285) true positives, 441 false positives (95% CI: 378 to 497), 259 true negatives (95% CI: 203 to 322) and 27 (95% CI: 15 to 51) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.

    MRI‐targeted biopsy compared to template‐guided biopsy: Based on a pooled sensitivity of 0.80 (95% CI: 0.69 to 0.87; 8 studies; low certainty of evidence) and a pooled specificity of 0.94 (95% CI: 0.90 to 0.97; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, MRI‐targeted biopsy may result in 240 (95% CI: 207 to 261) true positives, 42 (95% CI: 21 to 70) false positives, 658 (95% CI: 630 to 679) true negatives and 60 (95% CI: 39 to 93) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.

    The MRI pathway compared to template‐guided biopsy: Based on a pooled sensitivity of 0.72 (95% CI: 0.60 to 0.82; 8 studies; low certainty of evidence) and a pooled specificity of 0.96 (95% CI: 0.94 to 0.98; 8 studies; low certainty of evidence) using a baseline prevalence of 30%, the MRI pathway may result in 216 (95% CI: 180 to 246) true positives, 28 (95% CI: 14 to 42) false positives, 672 (95% CI: 658 to 686) true negatives and 84 (95% CI: 54 to 120) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations, inconsistency and imprecision.

    Systemic biopsy compared to template‐guided biopsy: Based on a pooled sensitivity of 0.63 (95% CI: 0.19 to 0.93; 4 studies; low certainty of evidence) and a pooled specificity of 1.00 (95% CI: 0.91 to 1.00; 4 studies; low certainty of evidence) using a baseline prevalence of 30%, systematic biopsy may result in 189 (95% CI: 57 to 279) true positives, 0 (95% CI: 0 to 63) false positives, 700 (95% CI: 637 to 700) true negatives and 111 (95% CI: 21 to 243) false negatives per 1000 men. We downgraded the certainty of evidence for study limitations and inconsistency.

    Agreement analyses: In a mixed population of both biopsy‐nave and prior‐negative biopsy men comparing the MRI pathway to systematic biopsy, we found a pooled detection ratio of 1.12 (95% CI: 1.02 to 1.23; 25 studies). We found pooled detection ratios of 1.44 (95% CI 1.19 to 1.75; 10 studies) in prior‐negative biopsy men and 1.05 (95% CI: 0.95 to 1.16; 20 studies) in biopsy‐nave men.

    Authors' conclusions
    Among the diagnostic strategies considered, the MRI pathway has the most favourable diagnostic accuracy in clinically significant prostate cancer detection. Compared to systematic biopsy, it increases the number of significant cancer detected while reducing the number of insignificant cancer diagnosed. The certainty in our findings was reduced by study limitations, specifically issues surrounding selection bias, as well as inconsistency. Based on these findings, further improvement of prostate cancer diagnostic pathways should be pursued.

    Plain language summary
    Is prostate MRI, with or without MRI‐targeted biopsy, better than systematic biopsy for detecting prostate cancer in men?

    Background

    Many prostate cancers are slow growing and may not have any harmful effects during a man's lifetime. Meanwhile, clinically significant cancers can cause problems such as blockage of the urinary tract, painful bone lesions and death. The prostate‐specific antigen (PSA) test followed by tissue samples of the prostate with ultrasound guidance is often used to detect these cancers early. More recently, magnetic resonance imaging (MRI) has also been used to help make the diagnosis.

    What is the aim of this review?

    The aim of this review was to compare MRI alone, MRI together with a biopsy, and a pathway that uses MRI to help decide whether to do a biopsy or not (hereinafter named ‘the MRI pathway’) with the standard ultrasound guided biopsy (hereinafter called ‘systematic biopsy’) in reference to template‐guided biopsy.

    What are the main results?

    We examined evidence up to July 2018. The review included 43 studies, mainly from Western countries, of men aged 61 to 73 years.

    In a population of 1000 men at risk for prostate cancer, where 300 men actually have clinically significant prostate cancer, MRI will correctly identify 273 men as having clinically significant prostate cancer but miss the remaining 27 men; for the 700 men that do not have clinically significant prostate cancer, MRI will correctly identify 259 as not having prostate cancer but will misclassify 441 men as having clinically significant prostate cancer.

    In the same population, MRI‐targeted biopsy will correctly identify 240 of 300 men as having clinically significant prostate cancer but miss the remaining 60 men; for the 700 men that do not have clinically significant prostate cancer, MRI will correctly identify 658 as not having prostate cancer but misclassify 42 men as having clinically significant prostate cancer.

    The MRI pathway will correctly identify 216 of 300 men as having clinically significant prostate cancer but miss the remaining 84 men; for the 700 men that do not have clinically significant prostate cancer, MRI pathway will correctly identify 672 as not having prostate cancer but will misclassify 28 men as having clinically significant prostate cancer.

    Systematic biopsies will correctly identify 189 of 300 men as having clinically significant prostate cancer but miss the remaining 111 men; for the 700 men that do not have clinically significant prostate cancer, systematic biopsies may correctly identify all 700 as not having prostate cancer and will not misclassify any men as having clinically significant prostate cancer.

    When comparing the MRI pathway to systematic biopsy in a mixed group of men who may or may not have had a prior biopsy, we found that MRI pathway is 12% more likely to make the correct diagnosis. In men without a prior biopsy, the MRI pathway is 5% more likely to make the correct diagnosis, whereas in men who have had a negative biospy, it is 44% more likely to make the correct diagnosis.

    How reliable is the evidence?

    We rated the quality of evidence for the main findings of this review as low. Additional high‐quality research is likely to change these findings.

    What are the implications of this review?

    The findings of this Cochrane review suggest that the MRI pathway is better than systematic biopsies in making a correct diagnosis of clinically significant prostate cancer. However, the MRI pathway still misses some men with clinically significant prostate cancer. Therefore, further research in this area is important.

  2. #122
    [#114]
    Liquid biopsy: Where did it come from, what is it, and where is it going?
    [2019]

    https://www.icurology.org/DOIx.php?i....2019.60.3.139

    If it seems like the term “liquid biopsy” is becoming as commonplace as “precision medicine,” that's because it probably is. While the phrase has been around for many years, recent interest has dramatically increased in parallel with major scientific advances in the field. The term is generally thought of as it relates to measuring tumor cells or nucleic acids circulating in the blood. However, as the expression has grown in popularity, it has been applied to urine and saliva in addition to sets of protein markers, such as in the 4Kscore which measures prostate specific antigen and related isoforms.

    Defining what constitutes a liquid biopsy is important here. The term biopsy implies direct measurement of a tumor, so the liquid biopsy moniker should be restricted to tests with specificity approaching that of a tissue biopsy. PCA3 is a long non-coding RNA measurable in urine and with strong performance characteristics for predicting the presence of prostate cancer. But with a specificity of approximately 75% at a commonly used cutoff of 35, it is nowhere near a surrogate for an actual biopsy. Further, a test that is based solely on measuring elevated serum levels of a protein (or proteins) secreted by a tumor, may be a great circulating tumor marker but not represent a liquid biopsy. Alpha-fetoprotein and human chorionic gonadotropin, for example, do not constitute a liquid biopsy for testis cancer any more than the prostate health index (PHI) does for prostate cancer.

    Notably, over the past several years, a number of exciting— and highly tumor-specific—approaches to performing liquid biopsies have been described. These methods are largely centered around the capture and analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the blood of patients with cancer. It is worth considering each of these approaches separately, as they provide different, and potentially complementary, information.

    CTC technologies are not new, but there remains only one US Food and Drug Administration (FDA)-approved platform (CellSearch; Menarini-Silicon Biosystems, Bryn Athyn, PA, USA). Like CellSearch, most CTC-enrichment methodologies rely on epithelial cell capture. There is an abundance of data in breast, colon, and prostate cancer demonstrating that the presence of these circulating epithelial cells is associated with more aggressive disease [1]. However, many CTCs may have downregulated expression of epithelial cell surface markers used for capture (such as through the process of epithelial-mesenchymal transition), highlighting a well-known potential weakness of epithelial capture-based approaches. Even most of the recent and highly innovative microfluidic-driven approaches to CTC capture include some reliance on epithelial marker expression in defining CTCs. While such CTC selection strategies may be effective in the vast majority of cases, a more agnostic, morphology-driven approach may allow detection of a wider variety of CTCs. For example, recent work using the Epic Sciences CTC platform demonstrated that prostate cancer CTCs can possess a great deal of phenotypic heterogeneity [2]. This heterogeneity itself can serve as a prognostic marker, with metastatic castration-resistant prostate cancer (mCRPC) patients demonstrating decreased overall survival in the context of greater heterogeneity.

    The tremendous challenges inherent to collecting clinically meaningful information from CTCs can't be overstated. A patient sample might have 10 CTCs in a background of 106 white blood cells and 109 red blood cells. With successful enrichment and isolation, however, there are numerous potential advantages of a CTC-based liquid biopsy. These advantages may be both logistical, such as the ease of collection and serial testing, and biological, as these CTCs may better reflect the whole-body burden of disease and provide a more encompassing snapshot than an isolated biopsy. Additionally, preservation of cellular contents by the cell membrane means gene expression information can be garnered from CTCs—even at the single cell level—in contrast to ctDNA-based liquid biopsy approaches. This is best exemplified by the work of Antonarakis and colleagues who demonstrated that expression of the AR-V7 splice variant in CTCs strongly predicts resistance to abiraterone and enzalutamide in mCRPC.

    Given the significant technical and biological challenges of CTC characterization, there has also been great enthusiasm for ctDNA detection and analysis. The ctDNA itself comes from apoptosis and necrosis of tumor cells, as well as from tumor cell exosome excretion, and it can account for anywhere from 0% to >50% of all detectable cell free DNA in circulation. In theory, ctDNA can be used to recapitulate existing precision medicine workflows, with analyses ranging from identification of point mutations to higher level assessment of copy number alterations and structural rearrangements. These assays often utilize polymerase chain reaction (PCR)-based approaches—effective for identifying tumor variants with known recurring mutations. Alternatively, next generation sequencing (NGS)-based techniques can be used to assay more genes and more mutations within each gene, along with copy number changes and gene fusions. NGS approaches are difficult, however, given the variable ctDNA content in the blood and potential need for expensive, ultra-deep sequencing to ensure detection of key alterations. We have recently proposed a stepwise approach, starting with ultra-low pass whole genome sequencing, as a potentially cost-effective strategy [3].

    Critically, ctDNA does appear to be an accurate representation of the tumor itself, which is an integral requirement for any liquid biopsy. Wyatt et al. [4] performed targeted sequencing of ctDNA and matched metastatic tissue biopsies in 45 patients with mCRPC. Copy number profiles and other gene alterations were identified from ctDNA in the majority of patients and were highly concordant with tissue sequencing. Of particular interest, a number of patients harbored clinically relevant alterations in their ctDNA that were not identified in their tumor biopsy, potentially indicative of tumor heterogeneity that isn't captured by a needle core. There is already one FDA-approved ctDNA assay, the Cobas epidermal growth factor receptor (EGFR) Mutation Test (Roche, Basel, Switzerland). This PCR-based assay detects specific EGFR mutations and may be used to direct use of EGFR tyrosine kinase inhibitor therapy in non-small cell lung cancer. Notably, though, patients with a negative test are still required to undergo tissue biopsy due to concern of false negative results. In prostate cancer, there is now evidence that ctDNA can be used to identify alterations in BRCA2, ATM, TP53, and AR that are associated with de novo resistance to abiraterone and enzalutamide [5].

    While these advances are encouraging, there is also reason for caution. Torga and Pienta [6] published a brief report after sending 40 paired patient samples for analysis on two CLIA-certified commercially available ctDNA platforms. The Guardant360 (Guardant Health, Inc., Redwood City, CA, USA) panel assess 73 genes while the PlasmaSelect (Personal Genome Diagnostics, Inc., Baltimore, MD, USA) test is a 64-gene panel. Findings for the 42 genes covered by both panels were compared, and, strikingly, there was little concordance between the two assays for the same patients. In this context, a potentially paradigm changing paper just published in Science deserves a similar level of caution. Cohen et al. [7] report on the CancerSEEK assay, which assesses for both ctDNA mutations and a panel of eight circulating protein markers. Developed as an early detection test for multiple cancer types (ovary, liver, stomach, pancreas, esophagus, colorectal, lung, and breast), the assay demonstrated a median sensitivity of 70% and a specificity >99%. While these data are exciting, the assay requires rigorous prospective study before being considered for clinical use.

    Going forward, technical advances and clinical implementation of liquid biopsy approaches will likely mirror that of tissue-based platforms for precision medicine. As tumor gene alterations are identified that can guide therapy choice, CTC and ctDNA-based tests will be developed to assess for these changes in a simple blood draw. As these advances continue, however, the core EGAPP (Evaluation of Genomic Applications in Practice and Prevention) framework of establishing both validity and utility will be absolutely essential prior to wide adoption of these tests in the clinic. The blood profiling atlas in cancer (BloodPAC) is large public-private collaborative seeking to systematically address these issues in order to help safely bring liquid biopsies into routine clinical care. To quote my colleague and former American Society of Clinical Oncology president Daniel Hayes, MD, “a bad biomarker test is as bad as a bad drug.” We need rigorous, prospective, randomized testing of these assays before we begin to use them to guide our clinical care.

  3. #123
    [#115]
    Observed racial disparity in the negative predictive value of multi-parametric MRI for the diagnosis for prostate cancer
    [2019]

    https://link.springer.com/article/10...55-019-02158-6

    Abstract

    Objective
    To evaluate the trend that despite recent advances in the screening, diagnosis, and management of prostate cancer (PCa), African-Americans (AAs) continue to have poorer outcomes compared to their Caucasian (CAU) counterparts. The reason for this may be rooted in biological differences in the cancer between the two groups; however, there may be some inherent disparities within the efficacy of the screening modalities. In this study, we aim to evaluate the negative predictive value (NPV) of multi-parametric MRI (mpMRI) between AA compared to CAUs.

    Methods
    All mpMRI between January 2014 and June 2017 were evaluated. The MRIs were read by dedicated genitourinary radiologists. Subsequently, the readings were correlated to final pathology after the patients underwent radical prostatectomy. The NPV and negative likelihood ratios (−LR) of mpMRI were evaluated in AAs versus CAUs based on four cutoffs (≥ Grade I, ≥ Grade II, ≥ Grade III and ≥ Grade IV).

    Results
    The mpMRI was almost equally as effective between AAs and CAUs in excluding Grade III (NPV = 89 and 94, respectively), and Grade IV or above (NPV = 96 and 98, respectively) PCa; however, the NPV of mpMRI was significantly lower for Grade I (NPV = 32 and 52, respectively) and Grade II (NPV = 50 and 79, respectively) PCa.

    Conclusion
    Despite advances in the screening for PCa, there are disparities noted in the efficacy of screening tools between AAs and CAUs. For this reason, patients should be risk stratified and their screening results should be evaluated with consideration given to their baseline risk.

  4. #124
    [#116]
    Prostate cancer upgrading or downgrading of biopsy Gleason scores at radical prostatectomy: prediction of "regression to the mean" using routine clinical features with correlating biochemical relapse rates
    [2019, Full Text]

    http://www.ajandrology.com/preprinta....asp?id=258497

    Abstract

    Recommendations for managing clinically localized prostate cancer are structured around clinical risk criteria, with prostate biopsy (PB) Gleason score (GS) being the most important factor. Biopsy to radical prostatectomy (RP) specimen upgrading/downgrading is well described, and is often the rationale for costly imaging or genomic studies. We present simple, no-cost analyses of clinical parameters to predict which GS 6 and GS 8 patients will change to GS 7 at prostatectomy. From May 2006 to December 2012, 1590 patients underwent robot-assisted radical prostatectomy (RARP). After exclusions, we identified a GS 6 cohort of 374 patients and a GS 8 cohort of 91 patients. During this era, >1000 additional patients were enrolled in an active surveillance (AS) program. For GS 6, 265 (70.9%) of 374 patients were upgraded, and the cohort included 183 (48.9%) patients eligible for AS by the Prostate Cancer Research International Active Surveillance Study (PRIAS) standards, of which 57.9% were upgraded. PB features that predicted a >90% chance of upgrading included ≥ 7 cores positive, maximum foci length ≥ 8 mm in any core, and total tumor involvement ≥ 30%. For GS 8, downgrading occurred in 46 (50.5%), which was significantly higher for single core versus multiple cores (80.4% vs 19.6%, P = 0.011). Biochemical recurrence (BCR) occurred in 3.4% of GS 6 upgraded versus 0% nonupgraded, and in GS 8, 19.6% downgraded versus 42.2% nondowngraded. In counseling men with clinically localized prostate cancer, the odds of GS change should be presented, and certain men with high-volume GS 6 or low-volume GS 8 can be counseled with GS 7-based recommendations.

  5. #125
    [#117]
    Early detection of prostate cancer using prostate-specific antigen testing: an empirical evaluation among general practitioners and urologists
    [2019]

    https://www.ncbi.nlm.nih.gov/pubmed/31114352

    Abstract

    Background: Prostate cancer (PCa) is the most frequent cancer and the third leading cause of cancer death among German men. One option for PCa early detection is prostate-specific antigen (PSA) testing, which is still under debate regarding its risk benefits. Besides recommendations on the early PCa detection, daily practice on PSA testing varies in, for example, information communication and usage of the test. This pilot study assessed potential differences between general practitioners (GPs) and urologists in handling PSA testing and guidelines on early detection of PCa. Methods: 172 GPs belonging to the teaching network of the University of Oldenburg in Lower Saxony and Bremen and 128 practicing urologists were included in the online survey focusing on PSA testing. The questionnaire covered 43 questions on topics as the usage of the test, information communication, handling of test results and handling of/knowledge about national and international guidelines on PCa. Wether PSA testing is used in accordance with guidelines was also explored in four standardized case scenarios. Statistical analysis was done at a descriptive level. Results: In total, 65 doctors participated in the survey (response proportion: 21.7%, n=65; 27.9%, n=48 [GPs]; 13.2%, n=17 [urologists]). Results of 41 GPs and 14 urologists were analyzed. The PSA test was judged as useful by all urologists, while almost half of the GPs valued the test as ambivalent or not useful. Urologists showed a more proactive approach of informing men on PSA testing. Regarding guidelines and recommendations on PSA testing, GPs were less familiar with them compared to the urologists. Doctors of both specialties did not always treat men in consistence with the guidelines. This was partially in contradiction to their self-appraisal. Conclusion: This pilot study is highlighting differences in PSA testing practices between GPs and urologists in Germany. Urologists showed a more proactive approach. For further verification, we plan a more comprehensive study covering several German states.
    [Emphasis mine]

  6. #126
    [#118]
    No added value of 18F-sodium fluoride PET/CT for the detection of bone metastases in patients with newly diagnosed prostate cancer with normal bone scintigraphy
    [2019]

    https://www.ncbi.nlm.nih.gov/pubmed/31147402

    Abstract

    Aim: To determine if additional 18F-sodium fluoride PET/CT (NaF-PET/CT) improves the prognostic accuracy in the initial staging of prostate cancer patients with normal bone scintigraphy undergoing prostatectomy. Methods: A prospective cohort study examined NaF-PET/CT in intermediate- or high-risk prostate cancer with negative bone scintigraphy who were scheduled for prostatectomy. Biochemical response: PSA levels<0.2 ng/mL at six weeks and six months postoperatively, PSA level≥0.2 ng/mL was biochemical failure. Results: Eighty-one patients were included in the study; seventy-five patients (93%) achieved biochemical responses, six patients had biochemical failure. NaF-PET/CT indicated bone metastasis in one patient (1.2%), was equivocal in seven patients (8.6%), without bone metastases in 73 patients (90.1%). Eight patients with bone metastases or equivocal results on NaF-PET/CT exhibited biochemical responses. All patients with biochemical failure had negative NaF-PET/CT and bone scintigraphy for bone metastases. Conclusion: NaF-PET/CT has no added value for bone staging in intermediate- and high-risk prostate cancer patients with normal bone scintigraphy results undergoing prostatectomy.

  7. #127
    [#119]
    Prostate Cancer Biopsy: Strategies
    [2018, Review, Full Text]

    https://link.springer.com/content/pd...603-7_70-1.pdf

    Abstract

    Prostate biopsy is the gold standard for the diagnosis of prostate cancer since many
    decades. Technical and material advances lead to a 10- to 12-core systematic biopsy as the state of the art to detect prostate cancer in
    case of an elevated PSA level or suspect digital rectal examination.
    Since prostate imaging modalities enable visualization of potentially malignant areas,
    biopsy paradigm started to change in favor of targeted biopsies for optimization of cancer detection. The implementation of the multiparametric magnetic resonance imaging (mpMRI) is now known to increase detection of clinically significant cancer, improve early risk stratification, and advise patients to an
    adequate therapy. A variety of different fusion techniques and biopsy platforms have been developed, showing not only diagnostic but also therapeutic relevance with great future
    potential by integrating biopsy and focal therapy.
    However, there is still a debate on the right indication to use systematic, targeted, or saturation biopsies and how to perform them. Biopsy strategies should pursue the following aims: accurate detection of clinically significant cancer, reduction of overdetection of insignificant cancer, high negative predictive value, immaculate risk assessment according to the final pathology in prostatectomy specimens, low morbidity, and clinical applicability

  8. #128
    [#120]
    Screening for prostate cancer: History, evidence, controversies and future perspectives toward individualized screening
    [2019, Review, Full Text]

    https://onlinelibrary.wiley.com/doi/...1111/iju.14039

    Abstract
    Differences in the incidence and mortality rate of prostate cancer between the USA and Japan have been decreasing over time, and were only twofold in 2017. Therefore, countermeasures against prostate cancer could be very important not only in Western countries, but also in developed Asian countries. Screening for prostate cancer in the general population using transrectal ultrasonography, digital rectal examination and/or prostate acid phosphatase began in Japan in the early 1980s, and screening with prostate‐specific antigen and digital rectal examination has been widespread in the USA since the late 1980s. Large‐ and mid‐scale randomized controlled trials on screening for prostate cancer began around 1990 in the USA, Canada and Europe. However, most of these studies failed as randomized controlled trials because of high contamination in the control arm, low compliance in the screening arm or insufficient screening setting about screening frequency and/or biopsy indication. The best available level 1 evidence is data from the European Randomized Study of Screening for Prostate Cancer and the Gteborg screening study. However, several non‐urological organizations and lay media around the world have mischaracterized the efficacy of prostate‐specific antigen screening. To avoid long‐term confusion about screening for prostate cancer, leading professional urological organizations, including the Japanese Urological Association, are moving toward the establishment of an optimal screening system that minimizes the drawbacks of overdetection, overtreatment and loss of quality of life due to treatment, and maximizes reductions in the risk of death as a result of prostate cancer and the development of metastatic prostate cancer.

  9. #129
    [#121]
    PI-RADS Steering Committee: The PI-RADS Multiparametric MRI and MRI-directed Biopsy Pathway
    [2019, Full Text]

    https://pubs.rsna.org/doi/full/10.11...iol.2019182946

    Abstract

    High-quality evidence shows that MRI in biopsy-naive men can reduce the number of men who need prostate biopsy and can reduce the number of diagnoses of clinically insignificant cancers that are unlikely to cause harm. In men with prior negative biopsy results who remain under persistent suspicion, MRI improves the detection and localization of life-threatening prostate cancer with greater clinical utility than the current standard of care, systematic transrectal US-guided biopsy. Systematic analyses show that MRI-directed biopsy increases the effectiveness of the prostate cancer diagnosis pathway. The incorporation of MRI-directed pathways into clinical care guidelines in prostate cancer detection has begun. The widespread adoption of the Prostate Imaging Reporting and Data System (PI-RADS) for multiparametric MRI data acquisition, interpretation, and reporting has promoted these changes in practice. The PI-RADS MRI-directed biopsy pathway enables the delivery of key diagnostic benefits to men suspected of having cancer based on clinical suspicion. Herein, the PI-RADS Steering Committee discusses how the MRI pathway should be incorporated into routine clinical practice and the challenges in delivering the positive health impacts needed by men suspected of having clinically significant prostate cancer.

    Summary
    The Prostate Imaging Reporting and Data System MRI-directed biopsy pathway enables the delivery of key diagnostic benefits to men suspected of having cancer according to their clinical priorities.

    Key Points
    ■ High-quality Prostate Imaging Reporting and Data System (PI-RADS)-compliant multiparametric MRI should be performed before prostate biopsy in most men who are suspected of having clinically significant disease and are likely to be offered active treatment.

    ■ A monitoring safety net must be in place for patients who decline immediate biopsy after MRI reveals a low likelihood of disease and should include clinical examination, laboratory assays, and imaging, as per local clinical practice and as consistent with clinical goals for individual patients; the roles and responsibilities of the participants and the circumstances that should trigger reinvestigations should be clearly defined.

    ■ For men proceeding to biopsy after MRI reveals intermediate or high likelihood of disease (ie, PI-RADS category 3 or higher), a combination of systematic and targeted biopsies should be performed in biopsy-naive men; only targeted biopsies are needed in men with persistent suspicion after prior negative systematic transrectal US-guided biopsy findings.

  10. #130
    [#122]
    Performance of systematic, MRI-targeted biopsies alone or in combination for the prediction of unfavourable disease in MRI-positive low-risk prostate cancer patients eligible for active surveillance
    [2019]

    https://link.springer.com/article/10...45-019-02848-x

    Abstract

    PURPOSE:
    To assess the upstaging/upgrading rates of low-risk prostate cancer (PCa) according to the biopsy scheme used (systematic (SB), targeted biopsies (TB), or both) in the setting of positive pre-biopsy MRI.

    PATIENTS AND METHODS:
    We included 143 consecutive men fulfilling the Toronto University active surveillance (AS) criteria who underwent a pre-biopsy positive MRI, a combination of SB and software-based fusion TB, and a radical prostatectomy, in two expert centres. The primary endpoints were the pathological upgrading and upstaging rates. Overall unfavourable disease (OUD) was defined by any pT3-4 and/or pN1 and/or ≥ GG 3.

    RESULTS:
    Using TB alone would have missed 21.7% of cancers including 16.7% of ≥ GG 3. The use of TB was significantly associated with a lower risk of ≥ Grade Group (GG) 3 disease (p < 0.006) in RP specimens. Combination of SB and TB lowered this risk by 39%, compared with TB alone. The biopsy scheme did not affect the upstaging rates which were substantial even in case of combination scheme (from 37 to 46%). OUD was detected in approximately 50% of cases. The presence of high grade on TB was the only independent predictive factor for both ≥ GG 2 (p = 0.015) and ≥ GG 3 (p = 0.023) in RP specimens.

    CONCLUSIONS:
    High grade on TB biopsies represented the major predictor of upgrading. Combination of SB and TB better defined the sub-group of patients having the lowest risk of reclassification, compared with TB or SB alone. The risk of non-organ-confined disease remained high, and could not be accurately predicted by MRI or systematic/targeted biopsy features.

 

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