Diagnosis Of Prostate Cancer In Men Research Articles

The risk of prostate cancer diagnosis in men with an elevated PSA but low IsoPSA.

292 Background: IsoPSA is a structure-based serum assay. Initial studies demonstrated that it outperformed total and percent-free PSA in detecting clinically significant prostate cancer (csPCa) (i.e., grade group (GG) ≥2) on biopsy. This led to an overall reduction in invasive testing and magnetic resonance imaging (MRI). We sought to compare the risk of csPCa in patients with an initially normal or high IsoPSA, thus assessing IsoPSA’s prospective predictive ability of csPCa. Methods: We performed a single-center retrospective review of patients (n=1578) who underwent IsoPSA testing from November 2016 to August 2022. Data was dichotomized into patients with normal (≤6) and high IsoPSA (>6). We collected the outcomes of any follow-up IsoPSA, prostate biopsy, MRI, and diagnosis of prostate cancer. In the case of multiple follow-up tests, the most recent one was recorded. Results: The median follow-up time of 1578 patients who underwent IsoPSA testing was 24 months (IQR 16-29). Among 541 patients with an initial normal IsoPSA, 60 (11.1%) had a subsequent high IsoPSA, 23 (4.3%) had csPCa on a subsequent biopsy, and 48 (8.9%) had suspicious lesions on MRI (PI-RADS 4-5). Among 1037 patients with an initial high IsoPSA, 366 (35.3%) had csPCa on a subsequent biopsy and 342 (33%) had suspicious lesions on MRI. The sensitivity of IsoPSA to predict csPCa was 94.1%, and its negative predictive value was 89.3%. Conclusions: With 24-month follow-up, 4.3% of patients with normal IsoPSA developed csPCa, suggesting that a low baseline IsoPSA provides durable information about the 2-year risk of csPCa.[Table: see text]

Clinical performance of magnetic resonance imaging and biomarkers for prostate cancer diagnosis in men at high genetic risk.

To evaluate different scenarios for the management of early diagnosis of cancer (PCa) in men at high genetic risk, using recently developed blood and urinary molecular biomarkers in combination with clinical information alongside multiparametric magnetic resonance imaging (mpMRI). A total of 322 patients with a high genetic risk (familial or personal history of cancers or a predisposing germline variant) were included in this study. The primary outcome was the detection rates of PCa (positive biopsy) or clinically significant PCa (biopsy with International Society of Urological Pathology [ISUP] grade >1). Clinical parameters included age, body mass index, ancestry, and germline mutational status,mpMRI, prostate-specific antigen density (PSAD), Prostate Health Index and urinary markers (Prostate Cancer Associated 3, SelectMdx™ and T2:ERG score) were assessed. Sensitivity (Se) and specificity (Sp) for each marker at their recommended cut-off for clinical practice were calculated. Comparison between diagnoses accuracy of each procedure and scenario was computed using mutual information based and direct effect contribution using a supervised Bayesian network approach. A mpMRI Prostate Imaging-Reporting and Data System (PI-RADS) score ≥3 showed higher Se than mpMRI PI-RADS score ≥4 for detection of PCa (82% vs 61%) and for the detection of ISUP grade >1 lesions (96% vs 80%). mpMRI PI-RADS score ≥3 performed better than a PSA level of ≥3 ng/mL (Se 96%, Sp 53% vs Se 91%, Sp 8%) for detection of clinically significant PCa. In case of negative mpMRI results, the supervised Bayesian network approach showed that urinary markers (with the same accuracy for all) and PSAD of ≥0.10 ng/mL/mL were the most useful indicators of decision to biopsy. We found that screening men at high genetic risk of PCa must be based on mpMRI without pre-screening based on a PSA level of >3 ng/mL, to avoid missing too many ISUP grade >1 tumours and to significantly reduce the number of unnecessary biopsies. However, urinary markers or a PSAD of ≥0.10 ng/mL/mL when mpMRI was negative increased the detection of ISUP grade >1 cancers. We suggest that a baseline mpMRI be discussed for men at high genetic risk from the age of 40 years.

MP16-13 CAN WE USE THE PROSTATE HEALTH INDEX TO AVOID A PROSTATE BIOPSY IN AFRICAN AMERICAN MEN?

You have accessJournal of UrologyCME1 May 2022MP16-13 CAN WE USE THE PROSTATE HEALTH INDEX TO AVOID A PROSTATE BIOPSY IN AFRICAN AMERICAN MEN? Kostantinos Morris, Srinath Kotamarti, and Judd Moul Kostantinos MorrisKostantinos Morris More articles by this author , Srinath KotamartiSrinath Kotamarti More articles by this author , and Judd MoulJudd Moul More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002549.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: African American (AA) race is a well-known risk factor for prostate cancer (PCa). However, the aggressive push to maximize detection of clinically significant cancer (CSC) is inevitably prone to high rates of over-biopsy. Prostate Health Index (PHI) is a Food and Drug Administration-approved tool to aid in the diagnosis of PCa in men with PSA 4-10 ng/ml. We sought to assess the effectiveness of PHI to avoid a prostate biopsy in AA men with an equivocal PSA. METHODS: Within the Duke Health System, AA men undergoing prostate biopsy with a PSA 4-10 ng/ml and PHI scores from 2016-2020 were identified. The cohort was analyzed for a PHI score cutoff for which 10% or less of men would be identified with CSC, defined as Gleason score ≥7. Representative 95% confidence intervals (CI) were calculated along with cancer detection rates. ROC curves for all PCa and CSC at biopsy were used to identify the area under the curve (AUC) and the diagnostic value of the proposed cutoff point. RESULTS: A total of 236 AA men with an average age of 61.2 years met inclusion criteria out of the 1,131 men who had PHI testing during the study period. Mean PHI and PSA for the entire cohort were 48.5 (SD 21.6) and 6.5 ng/ml (SD 1.7), respectively. Using the established lowest PHI cutoff of 27 led to six of 25 (24.0%) men diagnosed with CSC and 12 of 25 (48%) diagnosed with all PCa. Below a proposed PHI level of 23, one of 12 men were diagnosed with CSC (8.3% [CI: 0.002 – 0.385]) and two of 12 men were diagnosed with any PCa (16.7% [CI: 0.021 – 0.484]). Overall, PHI showed an AUC for all PCa and CSC of 0.705 (0.636 – 0.774) and 0.688 (0.621 – 0.755), respectively. PHI cut point of 23 was associated with a 98.7% sensitivity for all PCa and 99.0% for CSC, at a cost of specificities of 11.8% and 8.4%, respectively. Using this cut point 11 negative biopsies could be avoided, equating to 4.7% of the cohort. CONCLUSIONS: The currently accepted lowest PHI cut point leads to an excessively high rate of PCa in this cohort of AA men. Alternatively, men with a PHI below a proposed cutoff of 23 had optimally low rates of cancer detection and excellent sensitivity to minimize false negative biopsies. While our cohort is the largest reported of AA men undergoing PHI, further validation is needed to confirm these findings. Though generally at higher risk, AA men with an equivocal PSA and a PHI below 23 should be considered candidates to avoid a prostate biopsy. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e280 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kostantinos Morris More articles by this author Srinath Kotamarti More articles by this author Judd Moul More articles by this author Expand All Advertisement PDF DownloadLoading ...

A0519 - Exploring the association between cardiovascular disease risk and gonadotropin releasing hormones agonists (GnRH) and prostate cancer diagnosis in men with type 2 diabetes mellitus: A nationwide, population-based cohort study

A0519 - Exploring the association between cardiovascular disease risk and gonadotropin releasing hormones agonists (GnRH) and prostate cancer diagnosis in men with type 2 diabetes mellitus: A nationwide, population-based cohort study

Are Proinflammatory Cytokines Relevant for the Diagnosis of Prostate Cancer?

Inflammation plays an important role in prostate cancer (PCa). We evaluated proinflammatory cytokines regarding differential diagnosis of PCa in men with PSA levels between 2-10 ng/ml. Serum samples of 79 men (PSA 2-10 ng/ml) were analyzed for 10 proinflammatory cytokines (IL-6, IL-8, TNF-α, IFN-γ, IL-10, IL-1β, IL-2, IL-4, IL-12p70, IL-13) and results were evaluated regarding presence of PCa and disease severity. Significant differences between PCa patients and controls were found for IL-6 (p=0.002), IL-8 (p=0.030), and TNF-α (p=0.009), although they were not predictors of PCa in a logistic regression analysis. In addition, IL-6 and TNF-α levels were significantly higher in patients with high-risk PCa (p<0.05). No significant differences were observed regarding the other cytokines. In patients with PSA levels between 2-10 ng/ml, IL-6, IL-8, and TNF-α are associated with PCa, and IL-6 and TNF-α are associated with high-risk PCa.

Confirmatory biopsy of men under active surveillance: extended versus saturation versus multiparametric magnetic resonance imaging/transrectal ultrasound fusion prostate biopsy

Objective: The aim of this study was to evaluate the detection rate for clinically significant prostate cancer (PCa) after multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound (TRUS) fusion biopsy versus extended biopsy or saturation prostate biopsy (SPBx) in men enrolled on active surveillance (AS).Materials and methods: From May 2013 to January 2016, 100 men with very low-risk PCa were enrolled on AS. Eligible criteria were: life expectancy greater than 10 years, cT1c, prostate-specific antigen (PSA) below 10 ng/ml, PSA density less than 0.20 ng/ml², three or fewer unilateral positive biopsy cores, Gleason score (GS) equal to 6 and greatest percentage of cancer in a core 50% or lower. All patients underwent 3.0 T pelvic mpMRI before confirmatory transperineal extended biopsy (20 cores) and SPBx (median 30 cores) combined with mpMRI/TRUS fusion targeted biopsy (median four cores) of suspicious lesions [Prostate Imaging Reporting and Data System (PI-RADS) 3–5]. Clinically significant PCa was defined as the presence of at least one core with a GS of 4 or higher.Results: After confirmatory biopsy, 16 out of 60 (26.6%) patients showed significant PCa. Targeted biopsy of PI-RADS 4–5 versus PI-RADS 3–5 lesions diagnosed six out of 16 (37.5%) and 12 out of 16 (87.5%) significant PCa, respectively, with two false positives (5%). The detection rate for significant PCa was equal to 68.8% on mpMRI/TRUS fusion biopsy, 75% on extended biopsy and 100% on SPBx. mpMRI/TRUS targeted biopsy and extended biopsy missed five out of 16 (31.2%) and four out of 16 (25%) PCa, respectively.Conclusions: Although mpMRI may improve the diagnosis of significant PCa in men under AS, SPBx had a higher detection rate for clinically significant PCa.

Differences among Men on Active Surveillance for Very Low-Risk Prostate Cancer Detected Through Population-Based versus Opportunistic Prostate-Specific Antigen-Screening

Introduction: Very low-risk prostate cancer (PCa) is being increasingly managed by active surveillance (AS). Our aim was to assess the influence of the origin of diagnosis on PCa characteristics and treatment rates among men with very low-risk PCa in our prospective AS cohort. Methods: Overall, 191 men with very low-risk PCa fulfilling Epstein-criteria underwent protocol-based AS. These men originated either from the prospective population-based screening program (P-AS) or were diagnosed by opportunistic screening (O-AS). Results: Overall, n = 86 (45.0%) originated from the P-AS group, whereas n = 105 (55.0%) from the O-AS group. On univariate Cox regression analysis, age (HR 0.96, 95% CI 0.92-1.00; p = 0.05), origin of diagnosis (HR 0.72, 95% CI 0.41-1.28; p = 0.001), number of positive cores (HR 2.15, 95% CI 1.18-3.90; p = 0.01) and maximum core involvement (HR 1.03, 95% CI 0.99-1.05; p = 0.05) were predictors for treatment necessity. On multivariate analysis, age (HR 0.95, 95% CI 0.89-0.99; p = 0.05), number of positive cores (HR 2.07, 95% CI 1.10-3.88; p = 0.02), maximum core involvement (HR 1.03, 95% CI 1.00-1.06; p = 0.04) but not origin of diagnosis were independent predictors for treatment necessity. Four men developed biochemical recurrence (all from O-AS group [p = 0.05]). Conclusion: The origin of PCa diagnosis in men undergoing AS had no influence on disease progression and treatment necessity.

The Use of Free-Total Prostate Specific Antigen Ratio in Screening Prostate Cancer in Men with Specific Elevations of Prostate Specific Antigen

Aim: To evaluate the diagnostic performance of free-total PSA ratio using the criteria of total PSA > 4.0 ng/ml as the cut-off for prostate cancer diagnosis in men. Method: A total of sixty patients (mean age 58.03 ± 9.82) were recruited as test subjects from the cancer unit of National Obstetric Fistula Center (NOFIC), Abakaliki, Ebonyi State, Nigeria. All the patients had total PSA value above 4.0ng/ml. Free and total PSA estimations were done using the principle of Enzyme Linked Immunosorbent Assay (ELISA). Result: Free-total PSA ratio indicated high sensitivity (98.2% and 98.2%), specificity (87.9% and 82.9%) and positive predictive values (93.3% and 90%) for detecting undiagnosed prostate cancer at cut-offs of 0.25 and 0.19 respectively. High sensitivity (97.6%) and moderate specificity (61.7%) and positive predictive value (70.0%) were observed at cut off of 0.10. Using the free-total PSA ratio cut-off of ≤ 0.10 for prostate cancer, 70% of the test subjects were diagnosed of prostate cancer, on the other hand when a cutoff of > 0.25 was used, 6.7% of the test subjects were diagnosed of a possible benign prostatic hyperplasia. Conclusion: Free-total PSA ratio is a highly sensitive, specific and useful diagnostic tool alternative to total PSA assay for the screening of undiagnosed prostate cancer. Furthermore, it is highly predictive of the risk for developing prostate cancer at specific cutoff levels.

Dissecting the Association Between Metabolic Syndrome and Prostate Cancer Risk: Analysis of a Large Clinical Cohort

BackgroundA biologic rationale exists for the association between metabolic syndrome (MetS) and prostate cancer (PCa). However, epidemiologic studies have been conflicting. ObjectiveTo evaluate the association between MetS and the odds of PCa diagnosis in men referred for biopsy. Design, setting, and participantsPatients without prior PCa diagnosis undergoing prostate biopsy were identified from a large prostate biopsy cohort (in Toronto, Canada). The definition of MetS was based on the most recent interim joint consensus definition, requiring any three of five components (obesity, elevated blood pressure, diabetes or impaired fasting glucose, low high-density lipoprotein-cholesterol, and hypertriglyceridemia). Both the individual components of MetS and the cumulative number of MetS components were evaluated. Outcome measurements and statistical analysisThe outcomes were PCa detection overall, clinically significant PCa (CSPC; defined as any Gleason pattern ≥4, >50% involvement of a single biopsy core, or more than one of three total number of cores involved), and intermediate- or high-grade PCa (I-HGPC; Gleason 7–10). Tests for trend and multivariable logistic regression analyses were performed. Results and limitationsOf 2235 patients, 494 (22.1%) had MetS. No individual MetS component was independently associated with PCa. However, increasing number of MetS components was associated with higher PCa grade (p<0.001), as well as progressively higher odds of PCa outcomes (three or more; ie, MetS) compared with no MetS components: Odds ratios were 1.54 for PCa overall (95% confidence interval [CI], 1.17–2.04; p=0.002), 1.56 for CSPC (95% CI, 1.17–2.08; p=0.002), and 1.56 for I-HGPC (95% CI, 1.16–2.10; p=0.003) in multivariable analyses. The main limitation is the retrospective design. ConclusionsAlthough the individual MetS components are not independently associated with PCa outcomes, MetS is significantly associated with higher odds of PCa diagnosis, CSPC, and I-HGPC. There is a biologic gradient between the number of MetS components and the risk of PCa, as well as cancer grade. Patient summaryMetabolic syndrome is a collection of metabolic abnormalities that increases one's risk for heart disease. Our study shows that an increasing degree of metabolic abnormality is also associated with an increased risk of diagnosis of overall and aggressive prostate cancer.

Prostate health index (phi) and prostate cancer antigen 3 (PCA3) significantly improve diagnostic accuracy in patients undergoing prostate biopsy

Prostate health index (phi) and prostate cancer antigen 3 (PCA3) have been recently proposed as novel biomarkers for prostate cancer (PCa). We assessed the diagnostic performance of these biomarkers, alone or in combination, in men undergoing first prostate biopsy for suspicion of PCa. One hundred sixty male subjects were enrolled in this prospective observational study. PSA molecular forms, phi index (Beckman coulter immunoassay), PCA3 score (Progensa PCA3 assay), and other established biomarkers (tPSA, fPSA, and %fPSA) were assessed before patients underwent a 18-core first prostate biopsy. The discriminating ability between PCa-negative and PCa-positive biopsies of Beckman coulter phi and PCA3 score and other used biomarkers were determined. One hundred sixty patients met inclusion criteria. %p2PSA (p2PSA/fPSA × 100), phi and PCA3 were significantly higher in patients with PCa compared to PCa-negative group (median values: 1.92 vs. 1.55, 49.97 vs. 36.84, and 50 vs. 32, respectively, P ≤ 0.001). ROC curve analysis showed that %p2PSA, phi, and PCA3 are good indicator of malignancy (AUCs = 0.68, 0.71, and 0.66, respectively). A multivariable logistic regression model consisting of both the phi index and PCA3 score allowed to reach an overall diagnostic accuracy of 0.77. Decision curve analysis revealed that this "combined" marker achieved the highest net benefit over the examined range of the threshold probability. phi and PCA3 showed no significant difference in the ability to predict PCa diagnosis in men undergoing first prostate biopsy. However, diagnostic performance is significantly improved by combining phi and PCA3.

Abstract 1820: Genetic polymorphisms in microRNA target sites in IL-16 and IL-18 may be informative of time to prostate cancer diagnosis in African American men

Abstract Background: MicroRNAs (miRNAs) have recently been identified as promising markers to study for genetic susceptibility to cancer and have potential clinical utility in prostate cancer (PCA) risk assessment. Single nucleotide polymorphisms (SNPs) in genes encoding miRNA target sites for mRNA may interfere with miRNA binding to the mRNA, leading to aberrant mRNA expression and carcinogenesis. Here, we studied SNPs in 4 genes (ALOX15, IL-16, IL-18, and RAF1) with biologic relevance to PCA that encode mRNA with miRNA target sites. We evaluated these SNPs for association to race and time to PCA diagnosis in men at high risk for PCA (men with a family history [FH] of PCA and African American [AA] men) enrolled in a prospective early detection program to determine their future role in personalizing PCA early detection. Methods: The Prostate Cancer Risk Assessment Program (PRAP) is a prospective screening program for high risk men. PRAP has &amp;gt; 800 participants, and 60% are AA. Average follow-up is 4 years. Eligibility for PRAP includes men ages 35-69 years with one first degree relative with PCA, two second degree relatives with PCA on the same side of the family, any AA man regardless of FH of PCA, and men with BRCA1/2 mutations. Criteria for biopsy and biopsy approach have been reported previously. Genotyping methods included either Taqman® SNP Genotyping Assay (Applied Biosystems) or pyrosequencing. Standard sequencing was performed on 2% of the samples to confirm genotype calls. Standard statistical methods were used to determine risk-genotype distributions. Cox models were used for time to PCA diagnosis by risk genotype. Results: SNP genotypes were available for the following: n=749 for ALOX15, n=754 for RAF1, n=753 for IL-16, and n=766 for IL-18. There was a significant difference in distribution of miRNA target SNPs by race in ALOX15 (p&amp;lt;0.0001), RAF1 (p&amp;lt;0.0001), and IL-18 (p&amp;lt;0.0001). Among 278 AA men with &amp;gt; one follow-up visit, the TT genotype at rs1131445 in IL-16 was found to be significantly associated with earlier time to PCA diagnosis vs. the CC/CT genotypes (p=0.013). Hazard ratio after controlling for age and PSA for TT vs. CC/CT among AA men was 2.27 (p=0.0091). In addition, among 283 AA men with &amp;gt; one follow-up visit, the TT genotype at rs360727 in IL-18 was found to predict earlier time to PCA diagnosis vs CC/CT (p=0.017). Hazard ratio for PCA after controlling for age and PSA for TT vs. CC/CT among AA men was 4.44 (p=0.042). No trends in time to PCA diagnosis were seen among Caucasian men in PRAP for any of the miRNA target SNP genotypes. Conclusions: Genetic polymorphisms in miRNA target sites in IL-16 and IL-18 may be informative of time to PCA diagnosis among AA men enrolled in PCA risk assessment and may help to tailor screening and prevention recommendations in the future. Further study among high-risk men is warranted. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 1820. doi:10.1158/1538-7445.AM2011-1820

A Panel of Kallikrein Marker Predicts Prostate Cancer in a Large, Population-Based Cohort Followed for 15 Years without Screening

Prostate-specific antigen (PSA) has modest specificity for prostate cancer. A panel of four kallikrein markers (total PSA, free PSA, intact PSA, and kallikrein-related peptidase 2) is a highly accurate predictor of biopsy outcome. The clinical significance of biopsy-detectable cancers in men classified as low-risk by this panel remains unclear. The Malmö Diet and Cancer study is a population-based cohort of 11,063 Swedish men aged 45 to 73 providing a blood sample at baseline during 1991-1996. The Swedish Cancer Registry was used to identify 943 men diagnosed with prostate cancer by December 31, 2006. PSA testing was low. We assessed the predictive accuracy of our published statistical model to predict subsequent prostate cancer diagnosis in men with a total PSA level of 3.0 ng/mL or more at baseline. Compared with total PSA and age, the full kallikrein panel enhanced the predictive accuracy for clinically diagnosed prostate cancer (concordance index 0.65 vs. 0.75; P < 0.001). For every 1,000 men with a total PSA level of 3 ng/mL or more at baseline, the model would classify as high-risk 131 of 152 (86%) of the cancer cases diagnosed clinically within 5 years; 421 men would be classified as low-risk by the panel and recommended against biopsy. Of these, only 2 would be diagnosed with advanced prostate cancer (clinical T3-T4 or metastases) within 5 years. Men with a PSA level of 3 ng/mL or more but defined as low-risk by the panel of four kallikrein markers are unlikely to develop incurable prostate cancer. Use of the panel to determine referral to biopsy could substantially reduce the number of unnecessary prostate biopsies.

Effect of Dutasteride on Prostate Biopsy Rates and the Diagnosis of Prostate Cancer in Men with Lower Urinary Tract Symptoms and Enlarged Prostates in the Combination of Avodart and Tamsulosin Trial

BackgroundA 23% relative risk reduction (RRR) in prostate cancer (PCa) was shown in men receiving dutasteride in the 4-yr Reduction by Dutasteride of Prostate Cancer Events study, in whom biopsies were protocol dependent. ObjectiveOur aim was to explore PCa risk reduction in men with benign prostatic hyperplasia (BPH) from the Combination of Avodart and Tamsulosin (CombAT) study, in which biopsies were undertaken for cause. Design, setting, and participantsCombAT was a 4-yr randomized double-blind parallel group study in 4844 men ≥50 yr of age with clinically diagnosed moderate to severe BPH, International Prostate Symptom Score ≥12, prostate volume ≥30ml, and serum prostate-specific antigen (PSA) 1.5–10 ng/ml. Men underwent annual PSA measurement and digital rectal examination (DRE), and prostate biopsies were performed for cause. InterventionAll patients took tamsulosin 0.4mg/d, dutasteride 0.5mg/d, or a combination of both. MeasurementsThe primary end point was incidence of PCa. Secondary end points included postbaseline prostate biopsy rates and Gleason score of cancers. Results and limitationsDutasteride (alone or in combination with tamsulosin) was associated with a 40% RRR of PCa diagnosis compared with tamsulosin monotherapy (95% confidence interval, 16–57%; p=0.002) and a 40% reduction in the likelihood of biopsy. There were similar reductions in low- and high-grade Gleason score cancers. The biopsy rate in the groups receiving dutasteride trended toward a higher diagnostic yield (combination: 29%, dutasteride: 28%, tamsulosin: 24%). One limitation was the lack of a standardized approach to PCa diagnosis and grading. ConclusionsDutasteride, alone or in combination with tamsulosin, significantly reduced the relative risk of PCa diagnosis in men with BPH undergoing annual DRE and PSA screening. Consistent with the increased usefulness of PSA for PCa detection, men receiving dutasteride had a numerically lower biopsy rate and higher yield of PCa on biopsy. Trial registrationClinicaltrials.gov identifier: NCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).

UP-1.100: Prediction of the Probability of Prostate Cancer Diagnosis in Men with Serum PSA Values >4 Ng/Ml, Based on a Novel Mathematical Model

We present a novel mathematical model that aims to predict the probability of prostate cancer in patients with PSA values >4.0 ng/ml and to estimate the need for further evaluation of cases with negative initial prostate biopsies.

Negative influence of changing biopsy practice patterns on the predictive value of prostate-specific antigen for cancer detection on prostate biopsy

A correlation between prostate specific antigen (PSA) level and positive prostate biopsy rate was established in an era when biopsy practice patterns were different from what they are today. We evaluated if changes in biopsy practice patterns have affected the ability of PSA to predict cancer detection on prostate biopsy in the current era. Of 3634 prostate biopsies performed from 1993-2005, 1607 met criteria for analysis. Biopsy data were divided into 3 time-cohorts (1993-1997, 1998-2001, and 2002-2005) to assess for practice patterns shifts and correlation between PSA and biopsy results. Significant changes in biopsy practice patterns included an increase in biopsy cores and more frequent use of PSA 2.5-3.99 ng/mL as a biopsy indication. In men with normal DRE, a moderate correlation between PSA and positive biopsy rate did exist from 1993-1997, but was subsequently lost. On multivariate analysis, PSA was not a significant predictor of biopsy result in men with normal DRE. Early in the PSA era, the predictive power of PSA depended on multiple factors: high prevalence of disease, higher prevalence of high-grade disease, and low likelihood of prostate cancer diagnosis in men with low PSA. Now, beyond the culling effect of increased biopsy incidence and with shifted biopsy practice patterns, the correlation between PSA and biopsy result is lost in men with normal DRE. Diagnosing a higher proportion of tumors in men with a PSA between 2.0-4.0 ng/mL has negatively influenced the predictive value of PSA for cancer detection.

Prostate biopsy in subjects with abnormal transrectal ultrasonography but normal digital examination findings and prostate-specific antigen levels

The aim of the present study was to evaluate the value of transrectal ultrasonography (TRUS) for prostate cancer diagnosis in men with no other indication for biopsy, such as an abnormal digital rectal examination or abnormally high prostate-specific antigen (PSA) levels. The study cohort contained a total of 104 men aged 41-78 years (median 62.5 years) who had suspicious findings on TRUS. The median prostate volume of the patients was 33.0 ml (range 15.0-90.9) and the serum PSA ranged from 0.2 to 4.0 ng/ml (median 2.5 ng/ml). Of 104 men, 12 (11.5%) were diagnosed with prostate cancer on initial biopsy. The positive predictive value (PPV) was 3.7% for PSA 0.1-1.0 ng/ml, 4.8% for PSA 1.1-2.0 ng/ml, 16.7% for PSA 2.1-3.0 ng/ml and 18.4% for PSA 3.1-4.0 ng/ml. The PPV for cancer with Gleason score 7 or higher was 0.0%, 0.0%, 16.7% and 7.9%, respectively. No statistically significant differences in patient characteristics and biopsy results were found between patients who received only systemic biopsy and those who received systemic plus lesion-directed biopsies. The results of this study do not provide a rationale to recommend the additional use of lesion-directed biopsy in patients with suspicious lesions at TRUS but with no other indication for biopsy. Furthermore, our data raise the question of whether serum PSA levels lower than 4.0 ng/ml should be considered normal in Asian men.