Accuracy of PI-RADS v2 categories to predict prostate cancer at prostate biopsy in a large institutional cohort of men with previous negative biopsy

The association between PSA density, prostate cancer (PCa) and BPH is well established. The aim of the present study was to establish whether PSA density can be used as a reliable parameter to predict csPCa and to determine its optimal cutoff to exclude increased PSA levels due to intraprostatic inflammation. This is a large prospective single-center, observational study evaluating the role of PSA density in the discrimination between intraprostatic inflammation and clinically significant PCa (csPCa). Patients with PSA ≥ 4 ng/ml and/or positive digito-rectal examination (DRE) and scheduled for prostate biopsy were enrolled. Prostatic inflammation (PI) was assessed and graded using the Irani Scores. Multivariable binary logistic regression analysis was used to assess if PSA density was associated with clinically significant PCa (csPCa) rather than prostatic inflammation. A total of 1988 patients met the inclusion criteria. Any PCa and csPCa rates were 47% and 24% respectively. In the group without csPCa, patients with prostatic inflammation had a higher PSA (6.0 vs 5.0 ng/ml; p=0.0003), higher prostate volume (58 vs 52 cc; p<0.0001), were more likely to have a previous negative biopsy (29% vs 21%; p=0.0005) and a negative DRE (70% vs 65%; p=0.023) but no difference in PSA density (0.1 vs 0.11; p=0.2). Conversely in the group with csPCa, patients with prostatic inflammation had a higher prostate volume (43 vs 40 cc; p=0.007) but no difference in the other clinical parameters. At multivariable analysis adjusting for age, biopsy history, DRE and prostate volume, PSA density emerged as a strong predictor of csPCA but was not associated with prostatic inflammation. The optimal cutoffs of PSA density to diagnose csPCa and rule out the presence of prostatic inflammation in patients with an elevated PSA (>4 ng/ml) were 0.10 ng/ml2 in biopsy naïve patients and 0.15 ng/ml2 in patients with a previous negative biopsy. PSA density rather than PSA, should be used to evaluate patients at risk of prostate cancer who may need additional testing or prostate biopsy. This readily available parameter can potentially identify men who do not have PCa but have an elevated PSA secondary to benign conditions.

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68Ga-PSMA PET/CT Combined with PET/Ultrasound-Guided Prostate Biopsy Can Diagnose Clinically Significant Prostate Cancer in Men with Previous Negative Biopsy Results

Journal of Nuclear Medicine ◽

10.2967/jnumed.119.235333 ◽

2020 ◽

Vol 61 (9) ◽

pp. 1314-1319

Author(s):

Chen Liu ◽

Teli Liu ◽

Zhongyi Zhang ◽

Ning Zhang ◽

Peng Du ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Ultrasound Guided ◽

Negative Biopsy ◽

Psma Pet ◽

Pet Ct ◽

Clinically Significant

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MRI/US fusion prostate biopsy: Our initial experience

Archivio Italiano di Urologia e Andrologia ◽

10.4081/aiua.2016.4.296 ◽

2016 ◽

Vol 88 (4) ◽

pp. 296 ◽

Cited By ~ 3

Author(s):

Vito Lacetera ◽

Bernardo Cervelli ◽

Antonio Cicetti ◽

Giuliana Gabrielloni ◽

Michele Montesi ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Detection Rate ◽

Prostate Volume ◽

Initial Experience ◽

Fusion Biopsy ◽

Negative Biopsy ◽

Group A ◽

Group B ◽

Target Biopsy

Aim: The objective of this study is to present our initial experience with magnetic resonance imaging/ultrasound (MRI/US) fusion biopsy using the Koelis Trinity device after the first consecutive 59 patients. Materials and methods: 59 consecutive patients with suspected prostate cancer (PCA) underwent prostate biopsy using Trinity Koelis® (Koelis, Grenoble, France). We divided the patients into 2 groups: patients with a previous negative mapping underwent to a MRI/US fusion re-biopsy (Group A); and biopsy-naïve patients who underwent to a first stereotactic 3-D mapping of the prostate (Group B). Group A (22 patients):mean age 64 years (CI 48-73), mean PSA = 7.7 ng/ml (CI 4.2- 9.9); mean prostate volume 55 ml(CI 45-82), Digital Rectal Examination (DRE) positive in 2/22, number of lesions detected by MRI 1.4, mean cores from each MRI target lesion 3 (CI 2-5), mean total cores 15 ( CI 12-19). Group B (37 patients): mean age 66 years (CI 49-77), mean PSA= 4.7 (3.2- 7.9); mean prostate volume 45 ml (33-67), DRE positive in 5/37, mean total cores 14 ( CI 10-16) Results: In Group A 10/22 patients were positive for PCA (overall detection rate of 45.5%): 6 PCA were detected by target biopsy and 4 cancer by random biopsy. Significant prostate cancer (defined as the presence of Gleason pattern 4) was detected in 4/10 patients (Significant PCA detection rate of 40%) and all significant PCA were detected by MRI target biopsy. All PCA detected by random biopsy had Gleason score 3 + 3 = 6. In Group B (biopsy naïve patients) 14/37 patients were positive for PCA (overall detection rate of 37.8%), Significant prostate cancer was detected in 5/14 patients (Significant PCA detection rate of 35,7%). No significant side effects were recorded. Conclusions: Our overall detection rate was 45.5% and 37.8% in Group A (patients with previous negative biopsy and persistent suspicion of PCA) and in Group B (biopsy naïve patients) respectively; clinical significant PCA detection rate was respectively 40% and 35.7%. These results are similar to current literature and promising for the future. We believe that using platforms of co-registered MRI/US fusion biopsy can potentially improve risk stratification and reduces understaging, undergrading and the need for repeat biopsies in biopsy naïve patients (using a stereotactic first mapping) and in patients with previous negative biopsy and persistent suspicion of PCA ( using a second MRI/US fusion biopsy).

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Extensive prostate biopsy in patients suspicous for prostate cancer after at least 2 negative biopsy series

European Urology Supplements ◽

10.1016/s1569-9056(02)80643-1 ◽

2002 ◽

Vol 1 (1) ◽

pp. 165

Author(s):

Hans-Werner Gottfried ◽

Bjoern Volkmer ◽

Thomas Nesslauer ◽

Richard Hautmann

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Negative Biopsy

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LONG-TERM RISK OF DEVELOPING CLINICALLY MANIFESTED PROSTATE CANCER IN MEN WITH NEGATIVE BIOPSY RESULTS AT THE INITIAL MULTIPLE-CORE PROSTATE BIOPSY

The Journal of Urology ◽

10.1016/s0022-5347(09)62093-0 ◽

2009 ◽

Vol 181 (4S) ◽

pp. 750-751

Author(s):

Kazuto Ito ◽

Takumi Yamamoto ◽

Mai Miyakubo ◽

Hiroyuki Takechi ◽

Masaru Ohi ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Negative Biopsy

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Systematic and MRI-Cognitive Targeted Transperineal Prostate Biopsy Accuracy in Detecting Clinically Significant Prostate Cancer after Previous Negative Biopsy and Persisting Suspicion of Malignancy

Medicina ◽

10.3390/medicina57010057 ◽

2021 ◽

Vol 57 (1) ◽

pp. 57

Author(s):

Alvydas Vėželis ◽

Gediminas Platkevičius ◽

Marius Kinčius ◽

Liutauras Gumbys ◽

Ieva Naruševičiūtė ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Biopsy ◽

Specific Antigen ◽

Transrectal Ultrasound ◽

Targeted Biopsy ◽

Negative Biopsy ◽

Prostate Biopsies ◽

Clinically Significant ◽

Systematic Biopsy ◽

Targeted Biopsies

Background and objectives: Overdiagnosis, overtreatment, and the need for repeated procedures caused by transrectal ultrasound guided prostate biopsies and their related complications places a heavy burden on healthcare systems. This was a prospective cohort validating study to access the clinical accuracy of systematic and MRI-cognitive targeted transperineal prostate biopsies in detecting clinically significant prostate cancer after a previous negative biopsy and persistent suspicion of malignancy. The primary goal was to assess the ability of multiparametric magnetic resonance imaging (mpMRI) to detect clinically significant prostate cancer with an additional goal to assess the diagnostic value of systematic and MRI-cognitive transperineal biopsies. Materials and Methods: In total, 200 patients were enrolled who had rising serum prostate specific antigen (PSA) levels for at least 4 months after a previous negative transrectal ultrasound (TRUS) biopsy. All eligible men underwent 1.5T prostate mpMRI, reported using the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2), followed by a 20-region transperineal prostate systematic biopsy and additional targeted biopsies. Results: Systematic 20-core transperineal prostate biopsies (TPBs) were performed for 38 (19%) patients. Systemic 20-core TPB with additional cognitive targeted biopsies were performed for 162 (81%) patients. Clinically significant prostate cancer (csPC) was detected for 31 (15.5%) patients, of which 20 (64.5%) cases of csPC were detected by systematic biopsy, eight (25.8%) cases were detected by targeted biopsy, and three (9.7%) both by systematic and targeted biopsies. Conclusions: Cognitive mpMRI guided transperineal target biopsies increase the detection rate of clinically significant prostate cancer after a previously negative biopsy. However, in a repeat prostate biopsy setting, we recommend applying a cognitive targeted biopsy with the addition of a systematic biopsy.

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A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

10.21203/rs.3.rs-26752/v2 ◽

2020 ◽

Author(s):

James McKiernan ◽

Mikkel Noerholm ◽

Vasisht Tadigotla ◽

Sonia Kumar ◽

Phillipp Torkler ◽

...

Keyword(s):

Gene Expression ◽

Prostate Cancer ◽

Clinical Features ◽

Prostate Biopsy ◽

Repeat Biopsy ◽

Superior Performance ◽

High Grade ◽

Cut Point ◽

Negative Biopsy ◽

Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

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A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

10.21203/rs.3.rs-26752/v1 ◽

2020 ◽

Author(s):

James McKiernan ◽

Mikkel Noerholm ◽

Vasisht Tadigotla ◽

Sonia Kumar ◽

Phillipp Torkler ◽

...

Keyword(s):

Gene Expression ◽

Prostate Cancer ◽

Clinical Features ◽

Prostate Biopsy ◽

Specific Antigen ◽

Repeat Biopsy ◽

High Grade ◽

Cut Point ◽

Negative Biopsy ◽

Initial Biopsy

Abstract Background : Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate (IntelliScore) , or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods : As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results.Results : 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. Conclusions : The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

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A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

10.21203/rs.3.rs-26752/v3 ◽

2020 ◽

Author(s):

James McKiernan ◽

Mikkel Noerholm ◽

Vasisht Tadigotla ◽

Sonia Kumar ◽

Phillipp Torkler ◽

...

Keyword(s):

Gene Expression ◽

Prostate Cancer ◽

Clinical Features ◽

Prostate Biopsy ◽

Repeat Biopsy ◽

Superior Performance ◽

High Grade ◽

Cut Point ◽

Negative Biopsy ◽

Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

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Repeated biopsy in the detection of prostate cancer: When and how many cores

Archivio Italiano di Urologia e Andrologia ◽

10.4081/aiua.2014.4.311 ◽

2014 ◽

Vol 86 (4) ◽

pp. 311 ◽

Cited By ~ 1

Author(s):

Vincenzo Scattoni ◽

Andrea Russo ◽

Ettore Di Trapani ◽

Umberto Capitanio ◽

Giovanni La Croce ◽

...

Keyword(s):

Prostate Cancer ◽

Cancer Detection ◽

Prostate Biopsy ◽

English Language ◽

Transrectal Ultrasound ◽

Targeted Biopsy ◽

Negative Biopsy ◽

Transperineal Prostate Biopsy ◽

The Future ◽

Critical Literature

Purpose: We performed an analysis of the literature about the optimal prostate biopsy (PBX) scheme in the repeated setting Methods: We performed a clinical and critical literature review by searching Medline Database from January 2005 up to January 2014. Electronic searches were limited to the English language. The keywords were: prostate cancer, prostate biopsy, transrectal ultrasound, transperineal prostate biopsy. Results: The recommended approach in repeated setting is still the extended scheme (EPBx) (12 cores). An approach with more than 12 cores according to the clinical characteristics of the patients may optimize cancer detection. Saturation PBx (> 20 cores) clearly improves cancer detection if clinical suspicion persists after previous negative biopsy. Nevertheless international guidelines do not strongly recommended SPBx in all situations of repeated setting. EPBx or SPBX may be, in the future, substituted by multiparametric MRI-targeted biopsies. Conclusions: Since the scenario in which a PBx is changing, the issue about the number and location of the cores in PBx is still a matter of debate in repeated setting. At present, EPBx are still the gold standard even if SPBx seems to be necessary in many cases. However, random PBx does not represent the approach of the future, but rather imaging targeted biopsy.

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