Prostate cancer detection after a negative prostate biopsy: Lessons learnt in the Cleveland Clinic experience

Zaytoun, Osama; Jones, J. Stephen

doi:10.1111/j.1442-2042.2011.02798.x

Cited by 25 publications

(21 citation statements)

References 117 publications

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“…ASAP without any findings of malignancy was noted in 5.1% of the results of the initial prostate biopsies. ASAP is described as the presence of atypical glands not diagnostic of prostate cancer, and/or the absence of definitive architectural or cytological features of carcinoma (7,9). A repeat biopsy was performed on patients in whom ASAP was identified in the initial biopsy and who accepted a repeat biopsy.…”

Section: Methodsmentioning

confidence: 99%

How many cores should be taken in a repeat biopsy on patients in whom atypical small acinar proliferation has been identified in an initial transrectal prostate biopsy?

Aglamis

Kocaarslan

Yücetaş³

et al. 2014

Int. braz j urol.

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ARTICLE INfO ______________________________________________________________ ______________________Objective: To compare cancer detection rates according to the number of biopsy cores in patients on whom a repeat prostate biopsy was performed for atypical small acinar proliferation (ASAP). Materials and Methods:The data of 4950 consecutive patients on whom prostate biopsies were performed were assessed retrospectively. A total of 107 patients were identified as having ASAP following an initial prostate biopsy, and they were included in the study. A six-core prostate biopsy (PBx) was performed on 15 of the 107 patients, 12 PBx on 32 patients, and 20 PBx on 60 patients. Cancer detection rates were compared according to the number of biopsy cores. The localization of the cancer foci was also evaluated.Results: The cancer detection rates in patients on whom 6 PBx, 12 PBx, and 20 PBx were performed were 20% (3/15), 31% (10/32), and 58% (35/60), respectively, and a statistically significant difference was found (p = 0.005). When cancer detection rates in patients with total prostate specific antigen (PSA) < 10ng/mL, PSA density ≥ 0.15, normal digital rectal examination, and prostate volume ≥ 55mL were compared according to the number of biopsy cores, a significant difference was identified (p = 0.02, 0.03, 0.006, and 0.04, respectively). Seventy-five percent of the foci where cancer was detected were at the same and/or adjacent sites as the ASAP foci in the initial biopsy, and 54% were identified in contralateral biopsies in which ASAP foci were present. Conclusion: As the biopsy core number increases, the cancer detection rate increases significantly in patients on whom a repeat biopsy is performed due to ASAP. The highest cancer rate is found in 20-core repeat biopsies performed equally from all foci.

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Section: Methodsmentioning

confidence: 99%

How many cores should be taken in a repeat biopsy on patients in whom atypical small acinar proliferation has been identified in an initial transrectal prostate biopsy?

Aglamis

Kocaarslan

Yücetaş³

et al. 2014

Int. braz j urol.

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“…Various PSA derivatives were also devised to enhance the predictive accuracy for PCa detection, and these have also become widely used (4). However, clinical evidence regarding the efficacy of PSA and its derivatives to identify PCa in patients referred for a repeated PBx is still lacking (5,6), although the clinical utilities of these parameters in guiding repeated PBx decisions have been reported (2,(19)(20)(21).…”

Section: Discussionmentioning

confidence: 99%

“…Thirty percent of prostate cancer (PCa) cases are unfortunately missed during the initial prostate biopsy (PBx), although PBx is the diagnostic procedure of choice for PCa detection (1,2). Since negative initial PBx cannot conclusively exclude the presence of PCa, many men undergo repeated Various clinical and pathological findings have historically been considered risk factors for PCa after a negative initial PBx.…”

Section: Introductionmentioning

confidence: 99%

Clinical utility of prostate-specific antigen mass ratio for prediction of prostate cancer detection on a repeated prostate biopsy

Lee

Hong

et al. 2014

Int. braz j urol.

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ARTICLE INFO ______________________________________________________________ ______________________Purpose: To assess the clinical utility of the prostate-specific antigen mass ratio (PSA--MR), a newly developed PSA derivative, simply defined as the (i) PSA density (PSA-D) multiplied by the plasma volume or (ii) total PSA amount in circulation per prostate volume, for predicting prostate cancer (PCa) among men undergoing repeated prostate biopsy (PBx). Materials and Methods:Patients (n = 286), who underwent a repeated PBx, were analyzed. The various parameters associated with PCa detection were noted in each patient. PSA-MR was also calculated.Results: PCa was detected in 63 (22.0%) of 286 patients. PSA-MR was the independent predictor in the univariate-and multivariate logistic regression analyses (OR = 3.448, p = 0.001 and OR = 13.430, p = 0.033, respectively). A nomogram that incorporated PSA--MR was considered a useful tool (predictive accuracy: 79.2%, 95% CI: 0.726-0.858, p < 0.001). Furthermore, a nomogram that incorporated PSA-MR would have avoided 59.6% of unnecessary repeated PBx. The predictive accuracy of PSA-MR was also superior to that of PSA or PSA-D (p = 0.013 and 0.009, respectively). Conclusions: PSA-MR was an independent predictor, and its consideration would have avoided 59.6% of unnecessary repeated PBx for PCa detection. PSA-MR was also superior than PSA or PSA-D. Our results support the use of PSA-MR to facilitate counseling with patients after a negative initial PBx, and use of PSA-MR might reduce further unnecessary biopsies.

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“…Following this approach, assuming that approximately 25% of cancers are detected by repeat TRUS-guided needle biopsy 15 and that the cancer detection rate is approximately 25%, 16,17 then, based on a figure of 37,913 cases of prostate cancer in England and Wales, it can be assumed that 38,000 repeat biopsies are undertaken. The 2012-13 NHS reference costs 18 for the Healthcare Resource Group (HRG) of a needle biopsy of the prostate maps (LB27Z, outpatient procedure, urology) is £224, leading to a total cost to the NHS of approximately £8.5M in 2012-13.…”

Section: Biopsy Costmentioning

confidence: 99%

“…1,15,[66][67][68][69][70] As in all searches, the US FDA website was searched for the following terms: PCA3, phi and p2PSA.…”

Section: Searching Other Resourcesmentioning

confidence: 99%

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

Nicholson

Mahon

Boland

et al. 2015

Health Technol Assess

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BackgroundThere is no single definitive test to identify prostate cancer in men. Biopsies are commonly used to obtain samples of prostate tissue for histopathological examination. However, this approach frequently misses cases of cancer, meaning that repeat biopsies may be necessary to obtain a diagnosis. The PROGENSA®prostate cancer antigen 3 (PCA3) assay (Hologic Gen-Probe, Marlborough, MA, USA) and the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) are two new tests (a urine test and a blood test, respectively) that are designed to be used to help clinicians decide whether or not to recommend a repeat biopsy.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of the PCA3 assay and the phi in the diagnosis of prostate cancer.Data sourcesMultiple publication databases and trial registers were searched in May 2014 (from 2000 to May 2014), including MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science, Medion, Aggressive Research Intelligence Facility database, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register and World Health Organization International Clinical Trials Registry Platform.Review methodsThe assessment of clinical effectiveness involved three separate systematic reviews, namely reviews of the analytical validity, the clinical validity of these tests and the clinical utility of these tests. The assessment of cost-effectiveness comprised a systematic review of full economic evaluations and the development of a de novo economic model.SettingThe perspective of the evaluation was the NHS in England and Wales.ParticipantsMen suspected of having prostate cancer for whom the results of an initial prostate biopsy were negative or equivocal.InterventionsThe use of the PCA3 score or phi in combination with existing tests (including histopathology results, prostate-specific antigen level and digital rectal examination), multiparametric magnetic resonance imaging and clinical judgement.ResultsIn addition to documents published by the manufacturers, six studies were identified for inclusion in the analytical validity review. The review identified issues concerning the precision of the PCA3 assay measurements. It also highlighted issues relating to the storage requirements and stability of samples intended for analysis using the phi assay. Fifteen studies met the inclusion criteria for the clinical validity review. These studies reported results for 10 different clinical comparisons. There was insufficient evidence to enable the identification of appropriate test threshold values for use in a clinical setting. In addition, the implications of adding either the PCA3 assay or the phi to clinical assessment were not clear. Furthermore, the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination. No published papers met the inclusion criteria for either the clinical utility review or the cost-effectiveness review. The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective.LimitationsThe main limitations of the systematic review of clinical validity are that the review conclusions are over-reliant on findings from one study, the descriptions of clinical assessment vary widely within reviewed studies and many of the reported results for the clinical validity outcomes do not include either standard errors or confidence intervals.ConclusionsThe clinical benefit of using the PCA3 assay or the phi in combination with existing tests, scans and clinical judgement has not yet been confirmed. The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective.Study registrationThis study is registered as PROSPERO CRD42014009595.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Prostate cancer detection after a negative prostate biopsy: Lessons learnt in the Cleveland Clinic experience

Cited by 25 publications

References 117 publications

How many cores should be taken in a repeat biopsy on patients in whom atypical small acinar proliferation has been identified in an initial transrectal prostate biopsy?

How many cores should be taken in a repeat biopsy on patients in whom atypical small acinar proliferation has been identified in an initial transrectal prostate biopsy?

Clinical utility of prostate-specific antigen mass ratio for prediction of prostate cancer detection on a repeated prostate biopsy

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

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