False-positive screening results in the European randomized study of screening for prostate cancer

Kilpeläinen, Tuomas P.; Tammela, Teuvo L.J.; Roobol, Monique J.; Hugosson, Jonas; Ciatto, Stefano; Nelen, Vera; Moss, Sue; Määttänen, Liisa; Auvinen, Anssi

doi:10.1016/j.ejca.2011.06.055

Cited by 61 publications

(46 citation statements)

References 30 publications

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“…One major trial in men screened every 2 to 4 years concluded that, over 10 years, more than 15% of men experienced at least 1 false-positive test result. 5 Harms of diagnostic procedures include complications of prostate biopsy, such as pain, hematospermia (blood in semen or ejaculate), and infection. Approximately 1% of…”

Section: Harms Of Early Detection and Treatmentmentioning

confidence: 99%

“…In Sweden, where a low PSA threshold (3.0 ng/mL) was used to determine a positive test result and men were screened every 2 years, more than 45% of men who participated in all screening rounds had a false-positive result over 10 years of screening. 5 In the PLCO trial, more than two-thirds of men who underwent a prostate biopsy because of a positive PSA test result were found not to have prostate cancer. 13 In addition to false-positive results, there are other harms associated with screening and subsequent diagnostic evaluation; biopsies may result in pain, fever, hematospermia, and hospitalization.…”

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confidence: 99%

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Screening for Prostate Cancer

Grossman

Curry

Owens

et al. 2018

JAMA

1,009

223

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US Preventive Services Task Force IMPORTANCEIn the United States, the lifetime risk of being diagnosed with prostate cancer is approximately 11%, and the lifetime risk of dying of prostate cancer is 2.5%. The median age of death from prostate cancer is 80 years. Many men with prostate cancer never experience symptoms and, without screening, would never know they have the disease. African American men and men with a family history of prostate cancer have an increased risk of prostate cancer compared with other men.OBJECTIVE To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on prostate-specific antigen (PSA)-based screening for prostate cancer.EVIDENCE REVIEW The USPSTF reviewed the evidence on the benefits and harms of PSA-based screening for prostate cancer and subsequent treatment of screen-detected prostate cancer. The USPSTF also commissioned a review of existing decision analysis models and the overdiagnosis rate of PSA-based screening. The reviews also examined the benefits and harms of PSA-based screening in patient subpopulations at higher risk of prostate cancer, including older men, African American men, and men with a family history of prostate cancer.FINDINGS Adequate evidence from randomized clinical trials shows that PSA-based screening programs in men aged 55 to 69 years may prevent approximately 1.3 deaths from prostate cancer over approximately 13 years per 1000 men screened. Screening programs may also prevent approximately 3 cases of metastatic prostate cancer per 1000 men screened. Potential harms of screening include frequent false-positive results and psychological harms. Harms of prostate cancer treatment include erectile dysfunction, urinary incontinence, and bowel symptoms. About 1 in 5 men who undergo radical prostatectomy develop long-term urinary incontinence, and 2 in 3 men will experience long-term erectile dysfunction. Adequate evidence shows that the harms of screening in men older than 70 years are at least moderate and greater than in younger men because of increased risk of false-positive results, diagnostic harms from biopsies, and harms from treatment. The USPSTF concludes with moderate certainty that the net benefit of PSA-based screening for prostate cancer in men aged 55 to 69 years is small for some men. How each man weighs specific benefits and harms will determine whether the overall net benefit is small. The USPSTF concludes with moderate certainty that the potential benefits of PSA-based screening for prostate cancer in men 70 years and older do not outweigh the expected harms.CONCLUSIONS AND RECOMMENDATION For men aged 55 to 69 years, the decision to undergo periodic PSA-based screening for prostate cancer should be an individual one and should include discussion of the potential benefits and harms of screening with their clinician. Screening offers a small potential benefit of reducing the chance of death from prostate cancer in some men. However, many men will experience potential harms of screening, including false-positive results that r...

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Section: Harms Of Early Detection and Treatmentmentioning

confidence: 99%

mentioning

confidence: 99%

Screening for Prostate Cancer

Grossman

Curry

Owens

et al. 2018

JAMA

1,009

223

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“…13,15,19,21 False-positive results The rate of false-positive results varies depending on the PSA test threshold, ranging from 11.3% of all screened men at a threshold of 4.0 ng/mL to 19.8% at a threshold of 3.0 ng/mL. 23,24 The PLCO study used a threshold of 4.0 ng/mL (annual screening), and most sites in the ERSPC study used a threshold of 3.0 ng/mL (screening every 4 yr). Lower thresholds can increase the number of cases of cancer detected, but they also increase the risk of a false-positive result and diagnosis of indolent tumours of no clinical significance.…”

Section: Harms Of Screeningmentioning

confidence: 99%

Recommendations on screening for prostate cancer with the prostate-specific antigen test

Bell

Gorber

Shane

et al. 2014

CMAJ

166

136

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• The prevalence of undiagnosed prostate cancer at autopsy is high and increases with age (> 40% among men aged 40-49 yr to > 70% among men aged 70-79 yr).• Only a small proportion of men with prostate cancer have symptoms or die from the disease; most prostate cancers are slowly progressive and not life threatening.• Screening with the PSA test may lead to a small reduction in prostate cancer mortality but not a reduction in all-cause mortality.• Thresholds for PSA of 2.5 to 4.0 ng/mL are commonly used for screening; lower thresholds increase the probability of false-positive results, and no threshold completely excludes prostate cancer.• Harms associated with PSA screening (e.g., bleeding, infection, urinary incontinence, a false-positive result and overdiagnosis) are common.• The PSA test should not be used for screening without a detailed discussion with the patient, ideally with the use of decision aids to facilitate comprehension.

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“…(20–22) To examine the impact of PSA based PCa screening and the early detection of PCa, two large randomized controlled screening trials were conducted. (2, 3) The American Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial did not demonstrate a life saving benefit and the European Randomized Study of Screening for Prostate Cancer suggested that over 1000 men needed to be screened in order to save 1 life.…”

Section: Discussionmentioning

confidence: 99%

Impact of Prostate-specific Antigen on a Baseline Prostate Cancer Risk Assessment Including Genetic Risk

Kader

Liss

Trottier

et al. 2015

Urology

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Objective To determine to what extent prostate cancer risk prediction is improved by adding PSA to a baseline model including genetic risk. Materials and Methods Peripheral blood DNA was obtained from Caucasian men undergoing prostate biopsy at the University of Toronto (9/1/2008 – 1/31/2010). Thirty-Three PCa risk-associated single neucleotide polymorphisms (SNPs) were genotyped to generate the PGS-33. Primary outcome is PCa on study prostate biopsy. Logistic regression, area under the receiver-operating characteristic curves (AUC) and net reclassification improvement (NRI) were used to compare models. Results Among 670 subjects, 323 (48.2%) were diagnosed with PCa. The PGS-33 was highly associated with biopsy detectable PCa (OR 1.66, p=5.86E-05, AUC 0.59) compared to PSA (OR 1.33, p=0.01, AUC 0.55). PSA did not improve risk prediction when added to a baseline model (age, family history, DRE, and PGS-33) for overall risk (AUC 0.66 vs. 0.66; p=0.86) or Gleason ≥ 7 PCa (AUC 0.71 vs. 0.73; p=0.15). NRI analyses demonstrated no appropriate reclassifications with the addition of PSA to the baseline model for overall PCa but did show some benefit for reclassification of men thought to be at higher baseline risk in the high-grade PCa analysis. Conclusion In a baseline model of PCa risk including the PGS-33, PSA does not add to risk prediction for overall PCa for men presenting for “for cause” biopsy. These findings suggest that PSA screening may be minimized in men at low baseline risk.

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False-positive screening results in the European randomized study of screening for prostate cancer

Cited by 61 publications

References 30 publications

Screening for Prostate Cancer

Screening for Prostate Cancer

Recommendations on screening for prostate cancer with the prostate-specific antigen test

Impact of Prostate-specific Antigen on a Baseline Prostate Cancer Risk Assessment Including Genetic Risk

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