PCA3 Score Research Articles

The performance and limitations of PCA3, TMPRSS2:ERG, HOXC6 and DLX1 urinary markers combined in the improvement of prostate cancer diagnostics

BackgroundProstate cancer (PCa) is the second most commonly diagnosed cancer in men. To date, the role of the combined application of long non-coding RNAs (PCA3, DLX1, HOXC6, TMPRSS2:ERG) for obtaining the most accurate method of detection of PCa has not yet been comprehensively investigated. MethodsIn total 240 persons were included in the retrospective study. Among them were 150 patients with confirmed PCa, 30 patients with benign prostatic hyperplasia, 30 patients with active chronic prostatitis and 30 healthy volunteers. In all patients, the urine samples were collected prior to biopsy or treatment. Polymerase chain reaction with reverse transcription was performed to detect the expression level of PCA3, HOXC6, DLX1 and the presence of the TMPRSS2:ERG transcript. ResultsPCA3 was detected in urine samples in all cases. Using a PCA3 score of 56 allowed the differentiation between PCa and all other cases with a sensitivity of 61% and specificity of 96% (p < 0.001) while a PCA3 score threshold value of 50 resulted in a differentiation between clinically significant PCa (ISUP grades 2–5) and all other cases with a sensitivity of 93% and specificity of 93% (p < 0.001). The TMPRSS2:ERG expression in urine was detected exclusively in the group of patients with PCa and only in 16% of all cases. ConclusionsPCA3 score detected in urine demonstrated moderate sensitivity and good specificity in differentiation between PCa and non-PCa and high sensitivity and specificity in differentiation between clinically significant PCa and non-PCa.

Role of PCA3 and SelectMDx in the optimization of active surveillance in prostate cancer

Introduction & objectivesA not negligible percentage of patients included in active surveillance (AS) for low and very low risk prostate cancer (PCa) are reclassified in the confirmatory biopsy or have disease progression during follow-up. Our aim is to evaluate the role of PCA3 and SelectMDx, in an individual and combined way, in the prediction of pathological progression (PP) in a standard AS program. Materials & methodsProspective and observational study comprised of 86 patients enrolled in an AS program from 2009 to 2019, with results for PCA3 and SelectMDx previous to PCa diagnosis or during their confirmatory period. Univariate and multivariate analysis were performed to correlate PCA3 and SelectMDx scores as well as clinical and pathological variables with PP-free survival (PPFS). The most reliable cut-offs for both biomarkers in the context of AS were defined. ResultsSelectMDx showed statistically significant differences related to PPFS (HR 1.035, 95%CI: 1.012−1.057) (p = 0.002) with a C-index of 0.670 (95%CI: 0.529−0.810) and AUC of 0.714 (95%CI: 0.603−0.825) at 5 years. In our series, the most reliable cut-off point for SelectMDx was 5, with a sensitivity and specificity for PP of 69.8% and 67.4%, respectively. Same figure for PCA3 was 65, with a sensitivity and specificity for PP of 51.16% and 74.42%, respectively. The combination of both biomarkers did not improve the prediction of PP, C-index 0.630 (95%CI: 0.455−0.805). ConclusionsIn the context of low or very low risk PCa, SelectMDx > 5 predicted 5 years PP free survival with a moderate discrimination ability outperforming PCA3. The combination of both tests did not improved outcomes.

Association of Urinary MyProstateScore, Age, and Prostate Volume in a Longitudinal Cohort of Healthy Men: Long-term Findings from the Olmsted County Study

BackgroundSerum prostate-specific antigen (PSA), used in prostate cancer screening, is nonspecific for cancer and is affected by age and prostate volume. More specific biomarkers could be more accurate for early detection of prostate cancer and reduce unnecessary prostate biopsies. ObjectiveTo evaluate the association of age and prostate volume with urinary MyProstateScore (MPS) in a screened, longitudinal cohort without evidence of prostate cancer. Design, setting, and participantsThe Olmsted County Study included men aged 40–79 yr who underwent biennial prostate cancer screening. PSA ≥4.0 ng/ml or abnormal rectal examination triggered prostate biopsy, and patients with cancer were excluded. The remaining men submitted urinary specimens for PCA3 and TMPRSS2:ERG testing. Outcome measurements and statistical analysisMPS was calculated using the validated, locked model for grade group ≥2 cancer that includes serum PSA, urinary PCA3, and urinary TMPRSS2:ERG. The associations of age and volume with biomarkers were assessed in multivariable regression models. The t statistic was used to quantify the strength of associations independent of the unit of measurement, and R2 values were used to estimate the proportion of biomarker variance explained by each factor. Results and limitationsThe study included 314 screened men without evidence of cancer. In multivariable models including age and volume, PCA3 score was significantly associated with age (t = 7.51; p < 0.001), while T2:ERG score was not associated with age or volume. MPS was significantly associated with both age (t = 7.45; p < 0.001) and volume (t = 3.56; p < 0.001), but accounting for age alone explained the variability observed (R2 = 0.29) in a similar way to the model including age and volume (R2 = 0.31). The variability of PCA3, T2:ERG, and MPS was less dependent on age and volume than the variability for PSA (R2 = 0.45). ConclusionsIn a cohort of longitudinally screened men without evidence of cancer, we found that MPS demonstrated less variability with noncancer factors (age, prostate volume) than PSA did. These findings support the biology of these markers as more cancer-specific than PSA and highlight their promise in reducing the morbidity associated with PSA-based screening. Patient summaryIn a group of men with no evidence of prostate cancer, we found that each of three urine-based markers of cancer—PCA3, T2:ERG, and the commercially available MyProstateScore test—showed less variability with noncancer factors (age and prostate volume) than serum PSA (prostate-specific antigen) did. These findings support their proposed use as noninvasive markers of prostate cancer that could improve the accuracy of early detection.

Papel de PCA3 y SelectMDx en la optimización de la vigilancia activa en el cáncer de próstata

Introduction and objectivesA not negligible percentage of patients included in active surveillance (AS) for low and very low risk prostate cancer (PCa) are reclassified in the confirmatory biopsy or have disease progression during follow-up. Our aim is to evaluate the role of PCA3 and SelectMDx, in an individual and combined way, in the prediction of pathological progression (PP) in a standard AS program. Materials and methodsProspective and observational study comprised of 86 patients enrolled in an AS program from 2009 to 2019, with results for PCA3 and SelectMDx previous to PCa diagnosis or during their confirmatory period. Univariate and multivariate analysis were performed to correlate PCA3 and SelectMDx scores as well as clinical and pathological variables with PP-free survival (PPFS). The most reliable cut-offs for both biomarkers in the context of AS were defined. ResultsSelectMDx showed statistically significant differences related to PPFS (HR: 1.035; 95%CI: 1.012-1.057) (P=.002) with a C-index of 0.670 (95%CI: 0.529-0.810) and AUC of 0.714 (95%CI: 0.603-0.825) at 5years. In our series, the most reliable cut-off point for SelectMDx was 5, with a sensitivity and specificity for PP of 69.8% and 67.4%, respectively. Same figure for PCA3 was 65, with a sensitivity and specificity for PP of 51.16% and 74.42%, respectively. The combination of both biomarkers did not improve the prediction of PP, C-index 0.630 (95%CI: 0.455-0.805). ConclusionsIn the context of low or very low risk PCa, SelectMDx >5 predicted 5years PP free survival with a moderate discrimination ability outperforming PCA3. The combination of both tests did not improved outcomes.

Possibility of using PCA3 score without prostate massage in urine for diagnosing prostate cancer

Background. Prostate cancer holds one of the leading positions among malignant neoplasms in men. One of the most well-studied tumor-specific maskers is the PCA3 score in urine obtained after prostate massage. However, the study of the PCA3 score without prostate massage can significantly simplify the preanalytical phase of the study and minimize discomfort for the patient. Objective . Investigation of the diagnostic significance of PCA3, determined in urine sediment without prostate massage and its comparison with the PCA3 score after prostate massage. Materials and methods . The study included 2 groups of patients. In the first group (n = 50), the PCA3 score was assessed without prostate massage, and in the second group (n = 15) PCA3 was assessed in urine obtained before and after massage. Results. The area under the ROC-curve (AUC) for the PCA3 score without prostate massage was 0.722 (95 % confidence interval 0.579—0.865; p = 0.008). Using the ROC analysis, the threshold value, sensitivity and specificity were determined: 25, 72.41 % (95 % confidence interval 54.28— 85.30 %) and 57.14 % (95 % confidence interval 36.55—75.53 %), respectively. The PCA3 score after massage was found to be more sensitive than without prostate massage. A small volume of material, less than 20 ml, significantly affects the sensitivity of PCA3 without massage. Conclusion . PCA3 without prostate massage may serve as an option to improve the early diagnosis of prostate cancer, but its advantage over PCA3 after prostate massage has not been shown.

Prostatic aspirated cellular RNA analysis enables fast diagnosis and staging of prostate cancer

ObjectiveThe aim of this study is to investigate the potential application of prostatic aspirated cellular RNA analysis technique for fast diagnosing and staging prostate cancer. MethodsProstatic aspirated cells were obtained immediately after transrectal ultrasound (TRUS)-guided needle biopsy. Cellular RNA such as glyceraldehyde-3-phosphate dehydrogenase (GAPDH) mRNA, prostate specific antigen (PSA) mRNA and prostate-specific RNA (PCA3) mRNA were analyzed by using Reverse Transcription-Polymerase Chain Reaction (RT-PCR). PCA3 score was calculated as the ratio of PCA3 mRNA to PSA mRNA expression. Diagnostic performance of the fast-aspirated cellular RNA analysis technique for determining prostate cancer and metastatic status were evaluated by developing receiver operating characteristic curves (ROC), and the correlation between aspirated cellular RNA mRNA expressions and risk grouping was calculated, to investigate the underlying potential for PCa staging. ResultsPCA3 score was significantly higher in prostatic aspirated cells obtained from cancerous tissues than noncancerous tissues. The median aspirated cellular PCA3 score was higher in patients with PCa compared to BPH, and presenting an area under the ROC curve (AUC) of 0.87 (95%CI: 0.79–0.94) for PCa diagnosis. Multivariate regression analysis revealed that baseline median aspirated cellular PCA3 score (OR=9.316, 95%CI: 1.045–83.033, P<0.05) was an independent predictive factor for metastatic status in PCa patients. ConclusionThe ease of use and minimal complexity of fast prostatic aspirated cellular RNA analysis may be a valuable diagnostic technique, providing urgent diagnostic information for accurate PCa diagnosing and staging.

Identification of Clinically Significant Prostate Cancer by Combined PCA3 and AMACR mRNA Detection in Urine Samples.

PurposePreclinical evaluation of PCA3 and AMACR transcript simultaneous detection in urine to diagnose clinical significant prostate cancer (prostate cancer with Gleason score ≥7) in a Russian cohort.Patients and MethodsWe analyzed urine samples of patients with a total serum PSA ≥2 ng/mL: 31 men with prostate cancer scheduled for radical prostatectomy, 128 men scheduled for first diagnostic biopsy (prebiopsy cohort). PCA3, AMACR, PSA and GPI transcripts were detected by multiplex reverse transcription quantitative polymerase chain reaction, and the results were used for scores for calculation and statistical analysis.ResultsThere was no significant difference between clinically significant and nonsignificant prostate cancer PCA3 scores. However, there was a significant difference in the AMACR score (patients scheduled for radical prostatectomy p=0.0088, prebiopsy cohort p=0.029). We estimated AUCs, optimal cutoffs, sensitivities and specificities for PCa and csPCa detection in the prebiopsy cohort by tPSA, PCA3 score, PCPT Risk Calculator and classification models based on tPSA, PCA3 score and AMACR score. In the clinically significant prostate cancer ROC analysis, the PCA3 score AUC was 0.632 (95%CI: 0.511–0.752), the AMACR score AUC was 0.711 (95%CI: 0.617–0.806) and AUC of classification model based on the PCA3 score, the AMACR score and total PSA was 0.72 (95%CI: 0.58–0.83). In addition, the correlation of the AMACR score with the ratio of total RNA and RNA of prostate cells in urine was shown (tau=0.347, p=6.542e–09). Significant amounts of nonprostate RNA in urine may be a limitation for the AMACR score use.ConclusionThe AMACR score is a good predictor of clinically significant prostate cancer. Significant amounts of nonprostate RNA in urine may be a limitation for the AMACR score use. Evaluation of the AMACR score and classification models based on it for clinically significant prostate cancer detection with larger samples and a follow-up analysis is promising.

Diagnostic value of PCA3, TMPRSS2:ERG and prostatic specific antigen derivatives in the detection of prostate cancer

Background . Prostate cancer (PCa) is one of the most common malignancy in men. A traditional marker in the laboratory diagnosis ofPCa is the prostatic specific antigen (PSA). However, the low specificity of this marker leads to a large number of unnecessary biopsies. The emergence of various modifications of PSA and tumor-specific genetic markers such as PCA3 and TMPRSS2ERG, have improved the diagnosis of PCa. Objective . Investigation of the diagnostic significance of molecular genetic markers, PCA3 and TMPRSS2:ERG, and their comparison with markers based on PSA isoforms: free/total PSA ratio (%fPSA) and prostate health index (PHI). Materials and methods. The study included 58 men with suspected PCa. All patients were defined PCA3 score and the presence of TMPRSS2:ERG fusion transcript in the urine sediment. Also, PHI and %fPSA were determined in 48 and 51 men, respectively. Results. The area under the ROC-curve regardless of the value of PSA was higher for PCA3 score (0.773, p 95 % PCA3 score had the highest specificity, positive and negative predictive values in men, regardless of the level of PSA: 65.22, 80.95, and 93.75 %, respectively. In men with PSA level of 2—10 ng/ml the area under the ROC-curve for PCA3, %fPSA and PHI was 0.776 (p = 0.001), 0.629 (p = 0.144) and 0.729 (p = 0.009), respectively. At high sensitivity (>95 %) characteristics of the diagnostic test PCA3 in men with a PSA level of 2—10 ng/ml also also exceeded those for PHIand %>fPSA. The negative predictive valuefor PCA3score in this group ofmen was 100 %. The sensitivity ofdetection ofthe TMPRSS2:ERG fusion transcript in urine was 37.14 %, specificity 86.96 %, and the positive predictive value was 81.25 %. Conclusion. The use ofthe PCA3 score in combination with the detection of TMPRSS2:ERG fusion will improve the assessment of PCa risk in men with PSA levels between 2 and 10ng/ml (the “grey zone”).

Correlation of mRNA-PCA3 urine levels with the new grading system in prostate cancer

PurposeTo evaluate the PCA3 (Prostate Cancer 3 gene) as a tool to improve prostate cancer (PCa) screening and its capability to predict PCa aggressiveness. Patients and methodsA retrospective study with data from consecutive patients with suspected PCa seen in the urology department between November 2009 and April 2016 and who were candidates for prostate biopsy. A total of 1038 urine samples were tested in our laboratory with a kit that generated a PCA3 score (s-PCA3). A prostate biopsy was recommended only in those patients with s-PCA3≥35. Associations between variables were analyzed using the R software. ResultsIn patients with a positive s-PCA3 (44.5%), a subsequent biopsy was recommended. Of a total of 151 biopsies studied, 56.3% yielded a diagnosis of PCa. The probability of a positive biopsy increased as the s-PCA3 increased (p=0.041). The percentage of affected cylinders increased as the s-PCA3 increased (p=0.015). A statistically significant relationship was observed between s-PCA3 and both the Gleason score and the Grade Group (p=0.001 and 0.008, respectively). The best log-linear models and a logistic model confirmed the relationships shown previously with Fisher's exact tests. ConclusionsS-PCA3 may serve as an additional marker to reduce the indication for biopsies and avoid overdiagnosis and overtreatment of patients with suspected PCa. The prognostic significance of s-PCA3 was confirmed, as it was associated with tumor volume and Gleason score. Importantly, to our knowledge this is the first time that an association has been demonstrated between s-PCA3 and the new Grade Group.

Emerging biomarkers in the diagnosis of prostate cancer.

Prostate cancer (PCa) is the second most common cancer in men worldwide. A large proportion of PCa are latent, never destined to progress or affect the patients’ life. It is of utmost importance to identify which PCa are destined to progress and which would benefit from an early radical treatment. Prostate-specific antigen (PSA) remains the most used test to detect PCa. Its limited specificity and an elevated rate of overdiagnosis are the main problems associated with PSA testing. New PCa biomarkers have been proposed to improve the accuracy of PSA in the management of early PCa. Commercially available biomarkers such as PCA3 score, Prostate Health Index (PHI), and the four-kallikrein panel are used with the purpose of reducing the number of unnecessary biopsies and providing information related to the aggressiveness of the tumor. The relationship with PCa aggressiveness seems to be confirmed by PHI and the four-kallikrein panel, but not by the PCA3 score. In this review, we also summarize new promising biomarkers, such as PSA glycoforms, TMPRSS2:ERG fusion gene, microRNAs, circulating tumor cells, androgen receptor variants, and PTEN gene. All these emerging biomarkers could change the management of early PCa, offering more accurate results than PSA. Nonetheless, large prospective studies comparing these new biomarkers among them are required to know their real value in PCa detection and prognosis.

Modern urology perspectives on prostate cancer biomarkers.

IntroductionProstate cancer (PCa) is the most common type of cancer among men in Europe. Current recommendations for screening and diagnosis are based on prostate-specific antigen (PSA) measurements and the digital rectal examination (DRE). Both of them are triggers for prostate biopsy. Limited specificity of the PSA test brings, however, a need to develop new, better diagnostic tools. Several commercially available variations of the PSA test including: prostate health index (PHI), 4Kscore as well as molecular PCA3 score, have already revealed its value, lowering the number of unnecessary biopsies.Material and methodsThis review summarizes published results of the current most promising, clinically proven and experimentally evaluated PCa biomarkers which have potential for creation of new diagnostic tests.ResultsIn the last few years new approaches for providing significantly better biomarkers, an alternative to PSA, have been introduced. Modern biomarkers show improvement in being used as not only a diagnosis procedure, but also for staging, evaluating aggressiveness and managing the therapeutic process. The most promising group are molecular markers, among them microRNAs(miRNAs) and long noncoding RNAs (lncRNAs) are most frequent. Their superiority, over standard PSA, in predicting tumor formation in early stages, and clinically non-symptomatic metastases has been noticed. Extracellular vesicles presence in biofluids have brought focus of many research groups, indicating their potential significance. This group of nanoparticles has potential not only in diagnostic and therapy management process, but also as a potential therapeutic target.ConclusionsFinding better PCa biomarkers, replacing the current PSA measurement, is firmly needed in modern urology practice.

Clinical Utility of PCA3 Assay in Patients with Suspicious Prostate Cancer

Background: this study evaluated the clinical utility of the PCA3 assay in guiding initial biopsy decisions in prostate cancer. Subjects and Methods: this study was conducted on fifty patients selected from the Urology Department at Ain Shams University Hospitals and scheduled for prostate biopsy after digital rectal examination first catch urine was collected. PCA3 scores were determined using RT-PCR and compared to biopsy outcome. The diagnostic accuracy of PCA3 was compared to total prostate specific antigen and %free prostate specific antigen.Results: the best cutoff for PCA3 was 4.6 folds (RQ). This cutoff had a diagnostic sensitivity of 94.7%, specificity 95% and area under the curve (AUC) was 0.978. Total PSA at the cutoff 10 ng/mL had a diagnostic sensitivity 68%, specificity 70% and AUC was 0.766. At cut off 19%, f/t PSA ratio had a diagnostic sensitivity 38%, diagnostic specificity 90 %, and AUC was 0.529. Conclusions: the PCA3 assay can aid in guiding biopsy decisions. It is superior to total prostate specific antigen and %free prostate specific antigen in predicting initial biopsy outcome, and may be indicative of prostate cancer aggressiveness.

Urinary Biomarker Panel to Improve Accuracy in Predicting Prostate Biopsy Result in Chinese Men with PSA 4-10 ng/mL.

This study aims to evaluate the effectiveness and clinical performance of a panel of urinary biomarkers to diagnose prostate cancer (PCa) in Chinese men with PSA levels between 4 and 10 ng/mL. A total of 122 patients with PSA levels between 4 and 10 ng/mL who underwent consecutive prostate biopsy at three hospitals in China were recruited. First-catch urine samples were collected after an attentive prostate massage. Urinary mRNA levels were measured by quantitative real-time polymerase chain reaction (qRT-PCR). The predictive accuracy of these biomarkers and prediction models was assessed by the area under the curve (AUC) of the receiver-operating characteristic (ROC) curve. The diagnostic accuracy of PCA3, PSGR, and MALAT-1 was superior to that of PSA. PCA3 performed best, with an AUC of 0.734 (95% CI: 0.641, 0.828) followed by MALAT-1 with an AUC of 0.727 (95% CI: 0.625, 0.829) and PSGR with an AUC of 0.666 (95% CI: 0.575, 0.749). The diagnostic panel with age, prostate volume, % fPSA, PCA3 score, PSGR score, and MALAT-1 score yielded an AUC of 0.857 (95% CI: 0.780, 0.933). At a threshold probability of 20%, 47.2% of unnecessary biopsies may be avoided whereas only 6.2% of PCa cases may be missed. This urinary panel may improve the current diagnostic modality in Chinese men with PSA levels between 4 and 10 ng/mL.

Prostate Cancer Detection and Prognosis: From Prostate Specific Antigen (PSA) to Exosomal Biomarkers.

Prostate specific antigen (PSA) remains the most used biomarker in the management of early prostate cancer (PCa), in spite of the problems related to false positive results and overdiagnosis. New biomarkers have been proposed in recent years with the aim of increasing specificity and distinguishing aggressive from non-aggressive PCa. The emerging role of the prostate health index and the 4Kscore is reviewed in this article. Both are blood-based tests related to the aggressiveness of the tumor, which provide the risk of suffering PCa and avoiding negative biopsies. Furthermore, the use of urine has emerged as a non-invasive way to identify new biomarkers in recent years, including the PCA3 and TMPRSS2:ERG fusion gene. Available results about the PCA3 score showed its usefulness to decide the repetition of biopsy in patients with a previous negative result, although its relationship with the aggressiveness of the tumor is controversial. More recently, aberrant microRNA expression in PCa has been reported by different authors. Preliminary results suggest the utility of circulating and urinary microRNAs in the detection and prognosis of PCa. Although several of these new biomarkers have been recommended by different guidelines, large prospective and comparative studies are necessary to establish their value in PCa detection and prognosis.

Evaluation of PCA3 and multiparametric MRI's: collective benefits before deciding initial prostate biopsy for patients with PSA level between 3-10ng/mL.

ABSTRACTObjective To analyze the contribution of multiparametric MRI and PCA3 assay, pre- decision of initial biopsy in PSA level between 3-10 ng/mL patients with normal digital rectal examination(DRE).Materials and Methods PSA level 3-10 ng/mL ,patients, with normal DRE results and no previous prostate biopsy history, were included in this study. Each patient underwent multiparametric MRI one week before biopsy. Urine sample taking for PCA3 examination preceded the biopsy. Systematic and targeted biopsies were conducted. Patients with high PSA levels were seperated into two groups as: high PCA3 scored and low PCA3 scored. Then each group was divided into two sub-groups as: MRI lesion positive and negative. Tumor incidence, positive predictive values(PPV) and negative predictive values(NPV) were calculated.Results 53 patients were included between February 2013 and March 2014.Mean age 61.22 ± 1.06. Mean PSA value 5.13 ± 0.19 ng / mL. Mean PCA3 score 98.01 ± 23.13 and mean prostate size was 48.96 ± 2.67 grams. Fourty nine patients had both PCA3 score and multiparametric MRI. The PCA3’s PPV value was 58.33%. If multiparametric MRI lesions are added to high PCA3 scores , the PPV appears to elevate to 91.66%. NPV of PCA3 was 96%. NPV was 95% when there was no lesion in the multiparametric MRI with low PCA3 scores. Sensitivity was 91.66% , specificity was 95% respectively.Conclusion Adding multimetric MRI can also support biopsy decision for patients with high PCA3 value. When PCA3 value is low, patients can be survailled without any need to take a MRI.

506 MRI guided prostate biopsy: What is the place of PCA3 score?

506 MRI guided prostate biopsy: What is the place of PCA3 score?

Race, inflammation, and prostate cancer: A comparison of African Americans and Caucasians.

246 Background: African-Americans (AA) have the highest rate of prostate cancer (PCa) incidence and mortality. Studies have shown higher rates of chronic prostate inflammation in AAs compared to Caucasians (CA). In order to better understand racial disparity in PCa and chronic inflammation (CI), this study examined the effects of race and CI on clinical parameters among PCa patients. Methods: This retrospective study sample consisted of 61 AA and 52 CA PCa patients who underwent radical prostatectomies (RP) at Tulane Hospital between 2013 and 2015. Clinical data was extracted from biopsy and RP pathology reports. The study examined the relationship between CI, race, percent of positive cores, extra-prostatic extension, PSA, PSA density, urinary PCA3 and TMPRSS2, and prostate size (g). Pearson’s chi-square, Fisher’s exact, and Kruskal-Wallis tests were used to analyze categorical, non-continuous data; ANOVA tests were used to analyze continuous data. Differences between biopsy and surgical/pathologic Gleason scores and clinical/pathological stages were also assessed. Results: 94 patients (52 AAs and 42 CAs) had CI to some degree and 19 did not (9 AAs and 10 CAs). There was no difference in rate of CI between AA and CA patients (P = 0.526). Among all patients sampled, AAs had higher percentages of positive cores (P = 0.005), PCA3 copy levels (P =0.004), and PCA3 scores (P &lt;0.001), lower TMPRSS2 scores (P =0.039), and were more likely to have “high” or “intermediate” NCCN risk strata (P =0.010). Among patients with CI, AAs were more likely than CAs to have extra-prostatic extension (P =0.026) and less likely to have undergone a prior prostate biopsy (P =0.043). Patients without CI were more likely than patients with CI to have positive tumor margins (P =0.035) and SV invasion (P =0.013). There were no significant relationships between race and CI, and changes in either total Gleason score or stage from biopsy to RP. Conclusions: This study showed that AAs and patients without CI had more advanced forms of PCa (possibly due to PSA detection biases). Findings did not reveal any significant link between race and CI. Larger studies are needed to confirm these results and better understand the relationship between race, CI, and PCa.

Urinary PCA3 to predict prostate cancer in a cohort of 1015 patients

Summary Aim To evaluate the performance of urinary PCA3 test to predict prostate biopsy outcome in a large French cohort. Patients and methods A urine sample was prospectively obtained from 1015 patients undergoing prostate biopsies to determine the PCA3 score. The predictive value of PCA3 was explored using receiver operating characteristic curve analysis (ROC), multivariable logistic regression analysis and decision curve analysis. Results The median PCA3 score was significantly higher in patients with positive biopsies. The PCA3 score AUC was 0.76 (0.73–0.79), significantly higher than that of PSA (0.55; 0.51–0.58). At the cutoff of 35, sensitivity was 68%, specificity 71%, positive and negative predictive values 67% and 71%, and accuracy 69%. Using multivariate analysis, PCA3 score appeared as an independent predictor of biopsy outcome and its addition to a base model including usual clinicobiological parameters resulted in a significant increase in predictive accuracy. At the cutoff of 20, about 1/2 of the ultimately unnecessary biopsies would have been avoided while ignoring 7% of cancers with Gleason score ≥ 7. PCA3 score did not correlate with Gleason score but did correlate with tumor volume (proportion of positive cores). Conclusion Urinary PCA3 is a useful test with high diagnostic performances for early prostate cancer diagnosis. Its correlation with cancer aggressiveness seems rather represented by a link to prostate volume than Gleason score. Level of evidence 5.

Test urinaire PCA3 et diagnostic du cancer prostatique : étude à partir de 1015 patients

To evaluate the performance of urinary PCA3 test to predict prostate biopsy outcome in a large French cohort. A urine sample was prospectively obtained in 1015 patients undergoing prostate biopsies to determine the PCA3 score. The predictive value of PCA3 was explored using receiver operating characteristic curve analysis (ROC), multivariable logistic regression analysis and decision curve analysis. The median PCA3 score was significantly higher in patients with positive biopsies. The PCA3 score AUC was 0.76 (0.73-0.79), significantly higher than that of PSA (0.55; 0.51-0.58). At the cut-off of 35, sensitivity was 68 %, specificity 71 %, positive and negative predictive values 67 % and 71 %, and accuracy 69 %. Using multivariate analysis, PCA3 score appeared as an independent predictor of biopsy outcome and its addition to a base model including usual clinico-biological parameters resulted in a significant increase in predictive accuracy. At the cut-off of 20, about 1/2 of the eventual useless biopsies would have been avoided while ignoring 7 % of cancers with Gleason score ≥ 7. PCA3 score did not correlate to Gleason score but correlated to tumor volume (proportion of invaded cores). Urinary PCA3 is a useful test with high diagnostic performance for early prostate cancer diagnosis. Its correlation with cancer aggressiveness seems rather represented by a link to prostate volume than Gleason score.

PD44-07 EFFECTIVENESS OF SERUM PSA, URINE PCA3 AND URINE TMPRSS2:ERG FUSION AS A NOVEL URINARY BIOMARKER PANEL IN CLINICAL PRACTICE

You have accessJournal of UrologyProstate Cancer: Detection and Screening IV1 Apr 2015PD44-07 EFFECTIVENESS OF SERUM PSA, URINE PCA3 AND URINE TMPRSS2:ERG FUSION AS A NOVEL URINARY BIOMARKER PANEL IN CLINICAL PRACTICE John Wei, Javed Siddiqui, Rabia Siddiqui, Arul M. Chinnaiyan, Lakshmi P. Kunju, Rohit Mehra, Debbie Snyder, and Scott A. Tomlins John WeiJohn Wei More articles by this author , Javed SiddiquiJaved Siddiqui More articles by this author , Rabia SiddiquiRabia Siddiqui More articles by this author , Arul M. ChinnaiyanArul M. Chinnaiyan More articles by this author , Lakshmi P. KunjuLakshmi P. Kunju More articles by this author , Rohit MehraRohit Mehra More articles by this author , Debbie SnyderDebbie Snyder More articles by this author , and Scott A. TomlinsScott A. Tomlins More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2553AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES When new technology enters clinical practice, effectiveness deviates from efficacy due to external patient, provider, and systems related factors that may moderate its effect. PCA3, a prostate-specific noncoding gene that is significantly over-expressed in cancer and TMPRSS2(T2):ERG, a prostate cancer specific gene fusion, are both quantifiable by urinary assays that along with serum PSA comprise the testing panel Michigan Prostate Score (MiPS). This novel panel reports individual patient risk estimates for biopsy detection of any prostate cancer (MiPS) and high grade (Gleason score >6) cancer (HG MiPS). We examined the impact of this new test panel on clinical decision-making in men without cancer who were presenting for a prostate biopsy. METHODS During the past year, men referred for prostate biopsy at a single institution were offered MiPS as an alternative to proceeding directly to a biopsy. Patient characteristics, PSA, PCA3, T2:ERG, and biopsy pathology were analyzed to see how MiPS and HG MiPS affected the decision for prostate biopsy and pathology at biopsy. One-way ANOVA was used to compare PCA3, T2:ERG and risk levels. RESULTS 121 men (21.5% with prior biopsy) underwent MiPS testing with a mean age of 64 years, median PSA of 7 ng/ml, PCA3 score of 22, T2:ERG score of 2. Based on MiPS, the average predicted risk for detection of any and high grade cancer were 42.4% and 26.6%, respectively. Men who then chose to have a biopsy (n=58/47.9%) had higher MiPS (54.1% vs 31.6%, p<0.05) and HG MiPS scores (35.3% vs 18.5%, p<0.05) than those who did not. Among those biopsied, MiPS, HG MiPS, PCA3, T2:ERG were higher in those with high grade cancer found on biopsy but only T2:ERG was significantly higher (178.2 vs 44.5, p<0.05). CONCLUSIONS The combination of PSA, PCA3 and T2:ERG as a test panel for prostate cancer reduced the use of prostate biopsy in half. T2:ERG was strongly associated with detection of high grade cancer. These findings support the use of MiPS for assessing prostate cancer risk. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e899-e900 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Wei More articles by this author Javed Siddiqui More articles by this author Rabia Siddiqui More articles by this author Arul M. Chinnaiyan More articles by this author Lakshmi P. Kunju More articles by this author Rohit Mehra More articles by this author Debbie Snyder More articles by this author Scott A. Tomlins More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...