Lead Times and Overdetection Due to Prostate-Specific Antigen Screening: Estimates From the European Randomized Study of Screening for Prostate Cancer

Draisma, Gerrit; Boer, R. de; Otto, Suzie J.; Cruijsen, Ingrid W van der; Damhuis, Ronald A.; Schröder, Fritz H.; Koning, Harry J. de

doi:10.1093/jnci/95.12.868

Cited by 943 publications

(659 citation statements)

References 36 publications

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“…5 Recently, attention has been directed toward creating algorithms or nomograms that combine multiple clinical and laboratory features into risk scores to help in clinical decision making. [5][6][7][8] Nomograms are risk assessment tools that combine multiple clinical and laboratory risk factors to inform clinical decision making about biopsy, risk classification, and/or treatment options. Although there is wide variation in the manner in which the algorithms and nomograms have been developed and validated, a recent systematic review suggested that these tools tend to provide more accurate diagnostic predictions for cancer-positive biopsies than the use of PSA testing or other factors alone.…”

Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

“…Although there is wide variation in the manner in which the algorithms and nomograms have been developed and validated, a recent systematic review suggested that these tools tend to provide more accurate diagnostic predictions for cancer-positive biopsies than the use of PSA testing or other factors alone. 6 Recent reports described the use of PCA3 testing to identify patients with aggressive versus indolent prostate cancer. [9][10][11][12][13][14][15][16][17][18][19][20][21] Results of studies have been mixed.…”

Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

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Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Calonge

Klein

Berg

et al. 2014

Genetics in Medicine

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Summary of recommendations:The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend prostate cancer antigen 3 (PCA3) testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination).The EGAPP Working Group found insufficient evidence to recommend PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using PCA3 is deemed "low. " The EGAPP Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.Based on the available evidence, the overall certainty of net health benefit is deemed "low. " The EGAPP Working Group discourages clinical use unless further evidence supports improved clinical outcomes.Rationale: It has been suggested that PCA3 testing in the general male population might lead to earlier diagnosis and management changes (e.g., earlier detection and earlier initiation or higher rates of medical interventions) that improve outcomes. EGAPP Working Group found no direct evidence to support this possibility, so we sought indirect evidence aimed at documenting the extent to which PCA3 testing alters prostate cancer diagnosis or management, alone and in combination with traditional clinical management factors, and the extent to which this testing improves health outcomes.Analytic validity: Assay-related evidence was deemed adequate for the PROGENSA PCA3 assay approved by the US Food and Drug Administration, available from Gen-Probe. Very few studies were available that investigated preanalytical effects, analytical performance, and diagnostic accuracy of other quantitative assays for PCA3.Clinical validity: Evidence on clinical validity was rated inadequate to derive any conclusions about performance of PCA3 testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer, or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination). Furthermore, there was little evidence to derive any conclusions about performance of PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan. Clinical utility:No studies were available to provide direct evidence on the balance of benefits and harms related to PCA3 testing for diagnosis and management in the general male population. Evidence for other populations (e.g., high risk) was not evaluated in the review.

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Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Calonge

Klein

Berg

et al. 2014

Genetics in Medicine

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“…Within the screening arm of the ERSPC (section Rotterdam, the Netherlands), 27-56% of all cancers detected in men aged 55-75 years can be classified as potentially overdiagnosed. 18 …”

Section: Incidence and Mortality Of Pcmentioning

confidence: 99%

PSA-based prostate cancer screening: the role of active surveillance and informed and shared decision making

Venderbos¹,

Roobol²

2011

Asian J Androl

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Since the first publication describing the identification of prostate-specific antigen (PSA) in the 1960s, much progress has been made. The PSA test changed from being initially a monitoring tool to being also used as a diagnostic tool. Over time, the test has been heavily debated due to its lack of sensitivity and specificity. However, up to now the PSA test is still the only biomarker for the detection and monitoring of prostate cancer. PSA-based screening for prostate cancer is associated with a high proportion of unnecessary testing and overdiagnosis with subsequent overtreatment. In the early years of screening for prostate cancer, high rates of uptake were very important. However, over time the opinion on PSA-based screening has shifted towards the notion of informed choice. Nowadays, it is thought to be unethical to screen men without them being aware of the pros and cons of PSA testing, as well as the fact that an informed choice is related to better patient outcomes. Now, as the results of three major screening studies have been presented and the downsides of screening are becoming better understood, informed choice is becoming more relevant.

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“…It is estimated that a PSA screening programme will detect prostate cancers an average of 10-14 y prior to when they would have been diagnosed clinically (lead time bias). 4 Furthermore, given that prostate cancer often progresses only slowly, and that men are typically diagnosed in late middle age, early detection using PSA testing risks overdiagnosis, that is death from other causes before the cancer would have become symptomatic. The proportion of cases identified by PSA screening that are overdiagnosed is uncertain, and estimates vary between 29% 5 and 84%.…”

Section: The Natural History Of Early Prostate Cancermentioning

confidence: 99%

Active surveillance of early prostate cancer: rationale, initial results and future developments

Parker

2004

Prostate Cancer Prostatic Dis

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Active surveillance is a new strategy that aims to individualise therapy by selecting only those men with significant cancers for curative therapy based on early evidence of disease progression. Active surveillance must be distinguished from watchful waiting, which for decades has described a policy of observation with the use of palliative treatment for symptomatic progression. The rationale for active surveillance is discussed, based on our knowledge of the natural history of PSA-detected early prostate cancer. The initial results of active surveillance have demonstrated its feasibility. Ongoing studies seek to optimise the active surveillance protocol, and to determine the long-term outcomes. Looking ahead, dietary intervention in men on active surveillance could become an important new paradigm for prostate cancer management.

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Lead Times and Overdetection Due to Prostate-Specific Antigen Screening: Estimates From the European Randomized Study of Screening for Prostate Cancer

Abstract: These model-based lead-time estimates support a prostate cancer screening interval of more than 1 year.

Cited by 943 publications

References 36 publications

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

PSA-based prostate cancer screening: the role of active surveillance and informed and shared decision making

Active surveillance of early prostate cancer: rationale, initial results and future developments

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