Prostate-specific antigen 1.5-4.0 ng/mL: A diagnostic challenge and danger zone

University of Colorado, Anschutz Medical Campus, Aurora, 80045, USA.
BJU International (Impact Factor: 3.53). 06/2011; 108(11):1743-9. DOI: 10.1111/j.1464-410X.2011.10224.x
Source: PubMed


What's known on the subject? and What does the study add? Large population screening trials like the ERSPC, PCPT and PLCO have noted that men with seemingly low PSA (even as low as 0.5 ng/dL) still can have prostate cancer. Despite these findings, PSA is still predominantly used as a current indicator for possible presence of prostate cancer rather than also serving as a prognostic marker. This study examines a larger number of men in a diverse US population to determine the prognostic value of a man's baseline or first PSA.
• To assess the value of a PSA threshold of 1.5 ng/mL as a predictor of increased prostate cancer risk over a four-year period based on a man's first PSA test, including racial differences. • To review the risk of progression of benign prostatic hyperplasia (BPH) based on a similar PSA threshold.
• A retrospective review involving 21,502 men from a large Midwestern health system was performed. • Men at least 40 years old with baseline PSA values between 0 and 4.0 ng/mL and at least four years of follow-up after initial PSA test were included. • Optimal PSA threshold and predictive value of PSA for development of prostate cancer were calculated.
• Prostate cancer rates were 15-fold higher in patients with PSA ≥1.5 ng/mL vs patients with PSA <1.5 ng/mL (7.85% vs 0.51%). • African American patients with baseline PSA <1.5 ng/mL faced prostate cancer rates similar to the whole study population (0.54% vs 0.51%, respectively), while African American patients with PSA 1.5-4.0 ng/mL faced a 19-fold increase in prostate cancer.
• Both Caucasian and African American men with baseline PSA values between 1.5 and 4.0 ng/mL are at increased risk for future prostate cancer compared with those who have an initial PSA value below the 1.5 ng/mL threshold. • Based on a growing body of literature and this analysis, it is recommended that a first PSA test threshold of 1.5 ng/mL and above, or somewhere between 1.5 and 4.0 ng/mL, represent the Early-Warning PSA Zone (EWP Zone). • This should serve to inform patients and clinicians alike to future clinical activities with respect to prostate cancer and BPH.

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Available from: Judd W Moul, Mar 27, 2014
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    • "Ultimately, the optimal baseline cut-off PSA value for determining the risk of prostate cancer was 2.0 ng/mL for men in their 50s and 60s. The cut-off value for men in their 50s and 60s was slightly higher than those of western populations (9, 10). This difference is likely due to the lower rate of developing CaP in Korean men in this study. "
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    ABSTRACT: The present study evaluated optimal baseline prostate-specific antigen (PSA) level at different ages in order to determine the risk of developing prostate cancer (CaP). We analyzed 6,651 Korean men, aged 40-69 yr. The serum PSA levels for these men were measured at one institute from 2000 to 2004 and were determined to be between 0-4 ng/mL. Patients were divided into 4 groups of 25th-percentile intervals, based on initial PSA level. Of these, the group with an increased risk was selected, and the optimal value was determined by the maximal area under a receiver-operating characteristic curve within the selected group. The risk of CaP diagnosis was evaluated by Cox regression. The mean follow-up period was 8.3 yr. CaP was detected in 27 of the 6,651 subjects. CaP detection rate was increased according to age. The optimal PSA value to distinguish the risk of CaP was 2.0 ng/mL for 50- to 69-yr-olds. Patients with a baseline PSA level greater than the optimal value had a 27.78 fold increase in the prostate cancer risk. Baseline PSA values are useful for determining the risk of developing CaP in Korean men for 50- and 69-yr-old. We suggest that PSA testing intervals be modified based on their baseline PSA levels.
    Journal of Korean medical science 01/2012; 27(1):40-5. DOI:10.3346/jkms.2012.27.1.40 · 1.27 Impact Factor
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    ABSTRACT: This article aims to review the merits of the use of prostate-specific antigen (PSA) as a screening tool in the detection of prostate cancer and the evidence presented by the US and European population-based, randomized controlled trials evaluating screening. Many studies have attempted to ascertain whether PSA screening is beneficial with respect to cancer-specific mortality. This report aims to clarify the issues specific to the PSA test, prostate cancer, sources of bias, and the future of screening. We performed an Ovid-Medline literature search for articles pertaining to the introduction of the PSA test, its use for screening for prostate cancer, confounders and biases specific to PSA and prostate cancer's natural history, and reports specific to the Prostate, Lung, Colon, and Ovarian Cancer Screening Trial (PLCO), and the European Randomized Study of Screening for Prostate Cancer (ERSPC). We reviewed these articles and present relevant data. PSA emerged as one of the most-used serum tests to screen for cancer, particularly in the US, but in Europe as well. The PLCO trial showed no benefit to screening, and the ERSPC showed a 20% relative risk reduction of cancer-specific mortality. This translated to an absolute reduction of PCa-related deaths of 0.71 per 1,000. Each trial has criticisms that may or may not have affected power and outcome, although the rate ratios comparing screening to not screening are similar. Definitive evidence for or against screening is still lacking, as interim analyses from the ERSPC and PLCO await further follow-up in the years to come.
    World Journal of Urology 11/2011; 30(2):137-42. DOI:10.1007/s00345-011-0799-4 · 2.67 Impact Factor
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    ABSTRACT: RESUMEN Los motivos de ésta presentación es manifestar la preocupación que existe en el medio urológico mundial acerca de la controversia entre la asociación americana de urología (AUA) y la asociación europea de urología (EAU) en relación a la practica de los Cribados o Tamizaje de Población (Screening), que para los primeros no son procedentes por los costos económicos y psicológicos que causan y para los segundos son vitales ya que disminuye la mortalidad enfermedad-especifica en los pacientes detectados con elevaciones del PSA y que son llevados a diagnostico y tratamientos definitivos. El segundo motivo es que vemos como se están haciendo biopsias prostáticas innecesarias relacionadas con los valores absolutos de PSA total, ocasionando problemas de detección de canceres indolentes o clínicamente insignificantes y problemas de angustia tanto en el paciente como en su medio familiar circundante. El punto culminante de la investigación médica actual es dilucidar que cánceres prostáticos son indolentes y que cánceres son letales. Para eso se están dedicando miles de millones de dólares al año en investigaciones para sacar a la luz marcadores tumorales prostáticos que sean más específicos. Ahora bien no hay duda que el PSA es el mejor marcador tumoral que tenemos en la actualidad y desde 1980 cambió para siempre la expectativa de vida de los pacientes con cáncer de próstata, al punto que antes 3 de cada 4 pacientes al momento de su diagnostico eran incurables, hoy en día es lo contrario 3 de cada 4 pacientes son curables y eso gracias al antígeno prostático especifico que permite diagnósticos precoces. De lo que se trata es de hacer más juiciosa las indicaciones de estudios diagnósticos en pacientes con PSA total fuera de rango, ya que ocasionan deterioro en la calidad de vida de los pacientes y muchas veces ocasionan tratamientos innecesarios. ABSTRACT The reasons of this presentation is to show the concern in the media about the global urological dispute between the American Urological Association (AUA) and European Association of Urology (EAU) in relation to the practice of screening, that the former are not coming for economic and psychological costs that cause and for the latter are vital as it reduces disease-specific mortality in patients with elevations of PSA detected and are brought to definitive diagnosis and treatment. The second reason is that we see as unnecessary prostate biopsies are doing related to the absolute values of total PSA, causing problems of detecting indolent or clinically insignificant cancers and anxiety problems in both the patient and their family environment surrounding. The highlight of current medical research is to elucidate which prostate cancers are indolent and lethal cancers. For that you are spending billions of dollars a year on research to expose prostate tumor markers that are more specific. Now there is no doubt that the PSA is the best tumor marker that we have today and since 1980 has forever changed the life expectancy of patients with prostate cancer, to the
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