Prostate Cancer Detection in the “Grey Area” of Prostate-Specific Antigen Below 10 ng/ml: Head-to-Head Comparison of the Updated PCPT Calculator and Chun’s Nomogram, Two Risk Estimators Incorporating Prostate Cancer Antigen 3

Perdonà, Sisto; Cavadas, Vítor; Lorenzo, Giuseppe Di; Damiano, Rocco; Chiappetta, Gennaro; Prete, Paola Del; Franco, Renato; Azzarito, Giuseppina; Scala, Stefania; Arra, Claudio; Sio, Marco De; Autorino, Riccardo

doi:10.1016/j.eururo.2010.09.036

Cited by 76 publications

(49 citation statements)

References 17 publications

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“…Perdona et al 17 There are several limitations to this study. First, the retrospective nature of these data may create bias as not all individuals receiving a PCA3 assay underwent repeat biopsy.…”

Section: Discussionmentioning

confidence: 88%

Utility of PCA3 in patients undergoing repeat biopsy for prostate cancer

Reese

Cooperberg

et al. 2011

Prostate Cancer Prostatic Dis

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BACKGROUND: Men with persistently elevated and/or rising PSA levels after negative prostate biopsy often undergo multiple repeat biopsies. Prostate cancer antigen 3 (PCA3) has emerged as a predictor of prostate cancer. METHODS:We sought to define the utility of PCA3 in combination with other clinical data in predicting the risk of prostate cancer on repeat biopsy. We retrospectively obtained PCA3, PSA, PSA density (PSAD), digital rectal examination (DRE) and transrectal ultrasound (TRUS) findings from 103 patients at a single institution who had at least one prior negative prostate biopsy. The sensitivity and specificity of PCA3 in detecting prostate cancer was determined. Receiver operating characteristics curves were produced for each variable individually and in multivariable analysis, controlling for PCA3, PSAD, TRUS, PSA and DRE. A nomogram was created, internally validated and compared to another recently published nomogram. RESULTS:Of the 103 patients, 37 (31%) had prostate cancer on repeat biopsy. The sensitivity and specificity of PCA3 (using a cut point of 25) was 0.67 and 0.64, respectively. In multivariable analyses, PCA3 was independently associated with prostate cancer (odds ratio: 1.02, 95% confidence interval: 1.01-1.04), with area under the curve (AUC) of 0.64. A multivariable model containing PCA3, PSAD, PSA, DRE and TRUS findings showed the most diagnostic accuracy (AUC: 0.82). CONCLUSIONS:In the setting of prior negative biopsies, PCA3 was independently associated with prostate cancer in a multivariable model. In combination with other clinical data, PCA3 is a valuable tool in assessing the risk of prostate cancer on repeat biopsy.

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Section: Discussionmentioning

confidence: 88%

Utility of PCA3 in patients undergoing repeat biopsy for prostate cancer

Reese

Cooperberg

et al. 2011

Prostate Cancer Prostatic Dis

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“…However, 12 additional studies included matched results of PCA3 and the comparators but enrolled men with both initial and repeat biopsies or they did not report biopsy history. 10,11,[35][36][37][38][39][40][41][42][43][44] Most often, the results from these studies were not stratified by biopsy history.…”

Section: Clinical Validitymentioning

confidence: 99%

“…Fifteen studies [9][10][11]30,32,[34][35][36][37][38][39][40][41][42][43]46 reported AUC estimates for tPSA and PCA3 in the same population. Overall, 13 [9][10][11]30,32,34,35,37,38,[40][41][42]46 of the15 studies found that the AUC of PCA3 was higher than that of tPSA.…”

Section: Clinical Utilitymentioning

confidence: 99%

“…Four studies 32,35,39,40 provided sufficient data for analysis, and none of these reported a logarithmic SD. These were estimated from interquartile ranges or ranges.…”

Section: Clinical Utilitymentioning

confidence: 99%

“…A second study reported all but the interquartile range, which was estimated from the first study so that both data sets could be evaluated. These two studies 9,35 restricted recruitment patients in the "grey zone. " In both studies, the ratio of the odds ratios (PCA3/tPSA) was greater than 1 (1.38 and 1.97), and therefore, these calculations are likely to overestimate the relative superiority of PCA3 by underestimating tPSA performance.…”

Section: Clinical Utilitymentioning

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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Assessment of long‐term outcomes associated with urinary prostate cancer antigen 3 and TMPRSS2:ERG gene fusion at repeat biopsy

Merdan

Tomlins

Barnett

et al. 2015

Cancer

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BACKGROUND The long-term health outcomes associated with the use of urinary prostate cancer antigen 3 (PCA3) and TMPRSS2:ERG (T2:ERG) fusion in men with at least one previous negative biopsy and elevated serum prostate specific antigen (PSA) when making repeat biopsy decisions have not been investigated for clinically localized prostate cancer (PCa). METHODS We performed decision analysis using a decision tree for men with elevated PSA. The probability of cancer was estimated using the Prostate Cancer Prevention Trial risk calculator (PCPTRC version 2.0). We compared the use of PSA alone with PCA3 and T2:ERG, each used independently, in combination with PSA to trigger a repeat biopsy. When PCA3 and T2:ERG were used, a predefined threshold was used to determine whether to perform a repeat biopsy. Biopsy outcomes were defined as positive biopsy with Gleason Score (GS) of <7, 7, or >7, or negative biopsy. Probabilities and estimates of 10-year overall survival and 15-year cancer-specific survival were derived from previous studies and literature review. Outcomes were defined as age and GS dependent 10-year overall survival and 15-year cancer-specific survival, and percentage of biopsies avoided. RESULTS Incorporating PCA3 (biopsy threshold 25) or T2:ERG (biopsy threshold 10) into repeat biopsy decisions would have avoided 55.4% and 64.7% of repeat biopsies for the base case patient, respectively; changes in 10-year survival were only 0.93% and 1.41% percent, respectively. Multi-way sensitivity analysis suggests that our results are robust with respect to model parameters. CONCLUSIONS The use of PCA3 testing or T2:ERG for repeat biopsy decisions can reduce the number of biopsies substantially without significantly affecting 10-year survival.

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Prostate Cancer Detection in the “Grey Area” of Prostate-Specific Antigen Below 10 ng/ml: Head-to-Head Comparison of the Updated PCPT Calculator and Chun’s Nomogram, Two Risk Estimators Incorporating Prostate Cancer Antigen 3

Cited by 76 publications

References 17 publications

Utility of PCA3 in patients undergoing repeat biopsy for prostate cancer

Utility of PCA3 in patients undergoing repeat biopsy for prostate cancer

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

Assessment of long‐term outcomes associated with urinary prostate cancer antigen 3 and TMPRSS2:ERG gene fusion at repeat biopsy

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