Lower risk of prostate cancer in patients with sedentary occupations presenting for a prostate biopsy: Analysis of a Veterans Affairs cohort.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 257-257
Author(s):  
Rimaz M. Khadir ◽  
Rashid K. Sayyid ◽  
Martha K. Terris
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
High Volume ◽  
Veterans Affairs ◽  
High Grade ◽  
Increased Risk ◽  
Patient Reported

257 Background: Sedentary behavior has been associated with increased serum prostate-specific antigen (PSA) levels. It is currently unknown whether this correlates with an increased risk of underlying prostate cancer (PCa). Our objective was to determine whether patients with sedentary occupations presenting for a prostate biopsy were at increased risk of PCa diagnosis. Methods: A prospectively collected registry of patients undergoing a prostate biopsy between July 1995 and June 2016 at the Veterans Affairs Medical Center in Augusta, GA was utilized. The occupation was classified as sedentary if it was associated with prolonged periods of sitting (i.e. >50% work hours). This was determined via patient reported history at time of biopsy. The associations between a sedentary lifestyle and risk of a positive prostate biopsy, high grade cancer (i.e. Gleason score 8 or higher), and high volume cancer (i.e. at least 50% of total cores were positive) were evaluated using multivariable logistic regression analyses, controlling for age, race, body mass index, PSA level, free PSA ratio, clinical stage, prostate volume, and family history of prostate cancer. Statistical significance was set at p<0.05. All statistical analyses were performed using R version 3.6.1. Results: Our cohort included 1,914 patients. 271 (14.2%) patients had sedentary jobs. Median patient age was 61.0 years (Interquartile range [IQR] 57.0 – 66.0). Median PSA at time of biopsy was 5.7 ng/ml (IQR 4.4 – 8.2). Of the 1,914 initial biopsies performed, 974 (50.9%) were positive for malignancy. Of patients diagnosed with PCa, 229 (23.5%) had high-grade disease and 316 (32.4%) had high volume disease. On multivariable analysis, patients with a sedentary job had a significantly decreased risk of PCa diagnosis (Odds ratio [OR] 0.43, 95% confidence interval [CI] 0.18-1.03, p= 0.058), but no difference in odds of high grade (OR 0.63, 95% CI 0.089-2.99, p= 0.60) or high volume disease (OR 1.07, 95% CI 0.93-1.21, p= 0.89). Conclusions: Patients with sedentary occupations presenting for a prostate biopsy are at a lower apparent risk for a positive prostate biopsy. These results suggest that the serum PSA levels in such patients may be artificially elevated secondary to increased recumbence with no corresponding increase in risk of malignancy. [Table: see text]

scholarly journals Impact of early hypothalamic-pituitary-gonadal axis maturation on prostate cancer:Cross-sectional analysis of a Veterans Affairs cohort.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 255-255
Author(s):  
Rimaz M. Khadir ◽  
Rashid K. Sayyid ◽  
Martha K. Terris
Keyword(s):  
Prostate Specific Antigen ◽  
Prostate Biopsy ◽  
Odds Ratio ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Veterans Affairs ◽  
High Grade ◽  
Increased Risk ◽  
Risk Of Cancer

255 Background: Early onset of puberty, resulting in more prolonged exposure to higher androgen levels, has been hypothesized to be a risk factor for more aggressive prostate cancer (PCa) later in life. We sought to determine whether earlier age of first shave and height, as surrogates of pubertal onset, were associated with worsening PCa characteristics. Methods: A prospectively collected registry of patients presenting for a prostate biopsy at the Charlie Norwood Veterans Affairs Medical Center in Augusta, GA between July 1995 and June 2016 was utilized. Age of first shave and height were compared to the risk of cancer on prostate biopsy, high grade cancer (i.e. Gleason score 8 or higher), and high volume disease (i.e. at least 50% of total cores were positive) using univariable and multivariable logistic regression analysis, controlling for patient age, race, prostate specific antigen, percent free prostate specific antigen, clinical stage, prostate volume, body mass index, family history. Statistical significance was set at p < 0.05 and all statistical analyses were performed using R version 3.6.1. Results: Of the 1,176 patients analyzed, 599 (50.9%) had a cancer on prostate biopsy, of which 141 (23.5%) and 194 (32.4%) had high grade and volume disease, respectively. Median age of first shave was 17.0 years (interquartile range 16.0-19.0) and height was 177.8 cm (172.7-182.9). On multivariable analysis, later age of first shave was significantly associated with increased odds of a positive prostate biopsy (odds ratio for > 18 years versus < 16 years: 5.36, p = 0.03) and taller patients had significantly increased odds of high-grade cancer (odds ratio for 175-180 cm versus < 175 cm 7.41, p = 0.038). Conclusions: Among patients presenting for a prostate biopsy, those with a later age of first shave and taller height had an increased risk of a positive prostate biopsy and high-grade PCa, respectively. This suggests that patients with later age of puberty, and thus later testosterone surges, are at increased risk of overall and high-grade PCa. [Table: see text]

scholarly journals Vasectomy and Risk of Aggressive Prostate Cancer: A 24-Year Follow-Up Study

2014 ◽  
Vol 32 (27) ◽  
pp. 3033-3038 ◽  
Author(s):  
Mohummad Minhaj Siddiqui ◽  
Kathryn M. Wilson ◽  
Mara M. Epstein ◽  
Jennifer R. Rider ◽  
Neil E. Martin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Treatment ◽  
Specific Antigen ◽  
Prostate Cancer Risk ◽  
The United States ◽  
Low Grade ◽  
High Grade ◽  
Follow Up Study ◽  
Increased Risk

Purpose Conflicting reports remain regarding the association between vasectomy, a common form of male contraception in the United States, and prostate cancer risk. We examined prospectively this association with extended follow-up and an emphasis on advanced and lethal disease. Patients and Methods Among 49,405 US men in the Health Professionals Follow-Up Study, age 40 to 75 years at baseline in 1986, 6,023 patients with prostate cancer were diagnosed during the follow-up to 2010, including 811 lethal cases. In total, 12,321 men (25%) had vasectomies. We used Cox proportional hazards models to estimate the relative risk (RR) and 95% CIs of total, advanced, high-grade, and lethal disease, with adjustment for a variety of possible confounders. Results Vasectomy was associated with a small increased risk of prostate cancer overall (RR, 1.10; 95% CI, 1.04 to 1.17). Risk was elevated for high-grade (Gleason score 8 to 10; RR, 1.22; 95% CI, 1.03 to 1.45) and lethal disease (death or distant metastasis; RR, 1.19; 95% CI, 1.00 to 1.43). Among a subcohort of men receiving regular prostate-specific antigen screening, the association with lethal cancer was stronger (RR, 1.56; 95% CI, 1.03 to 2.36). Vasectomy was not associated with the risk of low-grade or localized disease. Additional analyses suggested that the associations were not driven by differences in sex hormone levels, sexually transmitted infections, or cancer treatment. Conclusion Our data support the hypothesis that vasectomy is associated with a modest increased incidence of lethal prostate cancer. The results do not appear to be due to detection bias, and confounding by infections or cancer treatment is unlikely.

scholarly journals Tumor-Associated Release of Prostatic Cells into the Blood after Transrectal Ultrasound-Guided Biopsy in Patients with Histologically Confirmed Prostate Cancer

2019 ◽  
Vol 66 (1) ◽  
pp. 161-168 ◽  
Author(s):  
Simon A Joosse ◽  
Burkhard Beyer ◽  
Christin Gasch ◽  
Paulina Nastały ◽  
Andra Kuske ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Tumor Cells ◽  
Prostate Biopsy ◽  
Standard Procedure ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Ultrasound Guided ◽  
Systemic Spread

Abstract BACKGROUND Transrectal ultrasound-guided prostate biopsy (TRUS) is a standard procedure for prostate cancer diagnosis. Because prostate cancer is a multifocal disease in many patients, multiple sampling (n ≥ 10) is required, which may bear the risk of systemic spread of cancer cells. DESIGN Using the standardized CellSearch® system that allows for the detection of single epithelial cell adhesion molecule-positive circulating tumor cells (CTCs) in blood, we investigated whether prostate biopsy is associated with release of prostatic tumor cells into the circulation. Peripheral blood was obtained before and within 30 min after performing prostate biopsy from 115 men with increased serum prostate-specific antigen. RESULTS The number of CTCs significantly increased after biopsy in men with histologically confirmed prostate cancer (odds ratio, 7.8; 95% CI, 4.8–12.8), whereas no biopsy-related changes could be detected in men without confirmed prostate cancer. Multivariable analysis showed that biopsy-related increase of CTCs was significantly correlated with a worse progression-free survival (hazard ratio, 12.4; 95% CI, 3.2–48.6) within the median follow-up of 41 months. CONCLUSIONS Prostate biopsies may lead to a tumor-associated release of CTCs into the blood circulation. Larger confirmatory trials with longer follow-up periods are required before any change in clinical practice can be recommended.

Association of baseline prostate atrophy with lower tumor volume in men with prostate cancer on repeat biopsy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 122-122
Author(s):  
Daniel M. Moreira ◽  
Gerald L. Andriole ◽  
Ramiro Castro ◽  
Stephen J. Freedland
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Tumor Volume ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Repeat Biopsy ◽  
Lower Baseline ◽  
Tumor Involvement ◽  
Biopsy Methods ◽  
Central Pathology

122 Background: We have previously shown baseline prostate atrophy (PA) was independently associated with lower prostate cancer (PC) risk. Beyond PC risk, for those who develop PC it is unclear whether PA is associated with smaller, less aggressive and/or less advanced tumors. Thus, we evaluated whether baseline PA and PA severity in men with initial negative biopsy for PC was associated with PC volume at the 2-year repeat prostate biopsy. Methods: Retrospective analysis of 763 men 50-75 years-old with negative baseline prostate biopsy and positive 2-year repeat biopsy for PC with complete data in the REDUCE study. Presence and severity of PA, and tumor volume were determined by central pathology. The association of PA at baseline biopsies with 2-year repeat biopsy cancer volume variables was evaluated with linear and Poisson regressions and controlling for age, race, body-mass index (BMI), digital rectal exam (DRE), prostate volume, baseline and pre-repeat biopsy prostate-specific antigen (PSA) and treatment arm. Results: PA was detected in 458 (60%) baseline biopsies and was considered mild in 398 (87%) and moderate in 60 (13%) cases. Patients with PA had significantly larger prostates and lower baseline and pre-repeat biopsy PSA (P < 0.01). PA was unrelated to race, BMI, DRE or treatment arm. At 2-year biopsy, men with baseline PA had significantly lower overall mean total tumor volume (2.04µL vs 3.02µL; P = 0.006), mean number of biopsy cores involved (1.79 vs 2.11; P = 0.001), mean percent of cores involved (17.9% vs 21.2%; P = 0.001), average core involvement (0.20µL vs 0.30µL; P = 0.001) and overall mean percent tumor involvement (1.64% vs 2.35%; P = 0.006) than those without PA. The results were virtually unchanged in multivariable analysis (all P < 0.05 except for overall percent tumor involvement where P = 0.061). In the analysis of PA severity, a biological gradient was observed where moderate PA was associated with greater reduction in tumor volume compared to mild PA (data not shown). Conclusions: In a cohort of men with 2-year repeat prostate biopsy positive for PC after a negative baseline biopsy, baseline PA was associated with lower PC volume. These results suggest PA may be associated with less aggressive PC.

Association of prostate specific-antigen doubling time (PSADT) with metastasis-free survival (MFS) and overall survival (OS) in non-metastatic castration-resistant prostate cancer (nmCRPC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16525-e16525 ◽  
Author(s):  
Jennifer H Lin ◽  
Brian Macomson ◽  
Ozgur Tunceli ◽  
Chris Pericone ◽  
Ajay S. Behl ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Linear Trend ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Continuous Variable ◽  
Castration Resistant Prostate Cancer ◽  
Increased Risk ◽  
Bone Scans ◽  
Practice Methods

e16525 Background: For optimal nmCRPC management, it is important to assess the rate of disease progression and its predictors. MFS and OS endpoints are likely to be important determinants in evaluating the relative impact of treatments in nmCRPC patients. This study assessed the association of PSADT with MFS and OS in real world practice. Methods: A retrospective cohort study of men ≥18 years old was conducted using the Optum electronic health record (EHR) database (2007-2016). nmCRPC was defined as a prostate cancer diagnosis, no ICD-9/10 code or therapy indicating metastatic disease, a testosterone (T) level < 50 ng/dL (castrate level) and 2 rising PSAs (relative rise ≥25%; absolute rise ≥2 ng/mL above nadir) ≥1 week apart. Baseline PSADT, calculated from the PSA nadir until 2nd rise of PSA, was grouped into < 6, 6-18 or > 18 months. A Cox proportional hazard model was used to assess the association of baseline PSADT with MFS and OS, comparing PSADT < 6 and 6-18 months against PSADT > 18 months. Multivariable analysis was adjusted for age, race, comorbidity index score, T levels, therapy and bone scans before nmCRPC. A linear trend was tested by taking PSADT as a continuous variable (median value in each group) in the model. Results: A total of 901 patients were identified. Mean nmCRPC onset age was 76 years and mean follow-up time was 2 years. The median PSADT was 7 months, ranging from 0.5 to 267 months. During follow-up, 477 patients developed metastasis and 384 died. MFS was 89%, 60%, and 47% at year 1, 3 and 5, respectively. Men with PSADT < 6 and 6-18 months had ≥50% increased risk of shorter MFS than men with PSADT > 18 months; hazard ratios (HR) were 1.87 (95% confidence interval [CI]: 1.39-2.54) and 1.50 (95%CI: 1.11-2.04), respectively. OS was 87%, 64% and 57% at year 1, 3 and 5, respectively. Shorter PSADT was associated with shorter OS (p for trend < 0.001). Men with a PSADT < 6 months had a 2-fold increased risk for decreased OS (HR = 2.04, 95% CI: 1.44-2.90). Conclusions: Patients with nmCPRC with shorter PSADT had significantly shorter MFS and OS compared to those with longer PSADT. Baseline PSADT may serve as a predictor for nmCRPC progression.

scholarly journals epiCaPture: A Urine DNA Methylation Test for Early Detection of Aggressive Prostate Cancer

2019 ◽  
pp. 1-18 ◽  
Author(s):  
Eve O’Reilly ◽  
Alexandra V. Tuzova ◽  
Anna L. Walsh ◽  
Niamh M. Russell ◽  
Odharnaith O’Brien ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dna Methylation ◽  
High Risk ◽  
Early Detection ◽  
Receiver Operating Characteristic ◽  
Prostate Biopsy ◽  
Operating Characteristic ◽  
Specific Antigen ◽  
High Grade ◽  
Cancer Of The Prostate

Purpose Liquid biopsies that noninvasively detect molecular correlates of aggressive prostate cancer (PCa) could be used to triage patients, reducing the burdens of unnecessary invasive prostate biopsy and enabling early detection of high-risk disease. DNA hypermethylation is among the earliest and most frequent aberrations in PCa. We investigated the accuracy of a six-gene DNA methylation panel (Epigenetic Cancer of the Prostate Test in Urine [epiCaPture]) at detecting PCa, high-grade (Gleason score greater than or equal to 8) and high-risk (D’Amico and Cancer of the Prostate Risk Assessment] PCa from urine. Patients and Methods Prognostic utility of epiCaPture genes was first validated in two independent prostate tissue cohorts. epiCaPture was assessed in a multicenter prospective study of 463 men undergoing prostate biopsy. epiCaPture was performed by quantitative methylation-specific polymerase chain reaction in DNA isolated from prebiopsy urine sediments and evaluated by receiver operating characteristic and decision curves (clinical benefit). The epiCaPture score was developed and validated on a two thirds training set to one third test set. Results Higher methylation of epiCaPture genes was significantly associated with increasing aggressiveness in PCa tissues. In urine, area under the receiver operating characteristic curve was 0.64, 0.86, and 0.83 for detecting PCa, high-grade PCa, and high-risk PCa, respectively. Decision curves revealed a net benefit across relevant threshold probabilities. Independent analysis of two epiCaPture genes in the same clinical cohort provided analytical validation. Parallel epiCaPture analysis in urine and matched biopsy cores showed added value of a liquid biopsy. Conclusion epiCaPture is a urine DNA methylation test for high-risk PCa. Its tumor specificity out-performs that of prostate-specific antigen (greater than 3 ng/mL). Used as an adjunct to prostate-specific antigen, epiCaPture could aid patient stratification to determine need for biopsy.

Effects of testosterone deficiency or manipulation on prostate cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 229-229
Author(s):  
Aksam Yassin ◽  
Dany-Jan Yassin ◽  
Peter Hammerer
Keyword(s):  
Prostate Cancer ◽  
Replacement Therapy ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Testosterone Replacement ◽  
Testosterone Replacement Therapy ◽  
Gleason Grade ◽  
Testosterone Deficiency ◽  
Increased Risk ◽  
Male Patients

229 Background: There is controversy over whether testosterone replacement therapy is a risk factor for prostate cancer. Herein, we evaluate whether testosterone deficiency (TD), testosterone replacement therapy (TRT) or 5-alpha reductase inhibitor (5-ARI) therapy affect the risk of prostate cancer. Methods: Data were collected from 224 male patients who had an indication for prostate biopsy: Prostate specific antigen (PSA) greater than 4, PSA-Velocity >=0.75 in a year, hypogonadism with PSA >=1.5, positive digital rectal exam (DRE) and/or positive Transrectal Ultrasonography (TRUS) finding. Each patient was then subjected to a TRUS-guided 10 core prostate biopsy. Results: 25% (3 out of 12) of the patients on TRT were found to have prostate cancer via biopsy and 32.1% (68 out of 212) of patients who did not receive TRT were found to have prostate cancer; insignificant with p = 0.757. Seventeen our of 76 (22.4%) of the patients on 5-ARI treatment were found to have prostate cancer and 36.5% (54 out of 148) of the patients who did not receive 5-ARI were found to have prostate cancer; significant with p = 0.03. There was no significant statistical difference in Gleason grades among patients who were on TRT, no TRT, on 5-ARI and no 5-ARI. Conclusions: Our data suggest that TRT is not associated with increased risk of prevalence or Gleason grade of prostate cancer. 5-ARI therapy is associated with lower prevalence of prostate cancer but with no relationship to Gleason grade.

Elevated HOXC6/DLX1 mRNA biomarker levels in urine to help select patients at increased risk for high-grade prostate cancer detection upon prostate biopsy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 31-31
Author(s):  
Rianne Hendriks ◽  
Siebren Dijkstra ◽  
Erik Bastiaan Cornel ◽  
Sander Jannink ◽  
Hans de Jong ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Score ◽  
Prostate Biopsy ◽  
Area Under The Curve ◽  
Risk Scores ◽  
Grey Zone ◽  
High Grade ◽  
Multicenter Studies ◽  
Biopsy Procedure ◽  
Increased Risk

31 Background: The major challenge in prostate cancer (PCa) diagnostics is to improve the early detection of clinically significant or high-grade PCa, especially in the sPSA "grey-zone" (4-10 ng/ml). Ideally, PCa-specific biomarkers would be obtained non-invasively, for example derived from urine. The aim of this study was to evaluate the expression levels and clinical utility of the recently identified urinary HOXC6-DLX1 mRNA biomarker combination in men at risk of having high-grade PCa. Methods: From two prospective, multicenter studies, a total of 863 post-DRE urine samples were collected from men with elevated sPSA levels before undergoing a prostate biopsy procedure. The HOXC6-DLX1 mRNA biomarkers were measured in urine using RT-qPCR and results were quantified using the Delta DeltaCt method (ΔΔCT), normalized and expressed in a score from 1 to 1421. Results: The HOXC6-DLX1 risk score was significantly higher in urine from patients with high-grade PCa upon prostate biopsy compared to no PCa and PCa Gleason score ≤6. In the sPSA "grey-zone", the HOXC6-DLX1 combination had the highest area-under-the-curve (AUC) of 0.67 (95% confidence interval (CI): 0.58-0.75) for prediction of high-grade PCa upon prostate biopsy in cohort A and 0.68 (95% CI: 0.59-0.76) in cohort B; as compared to sPSA with an AUC of 0.60 (95% CI: 0.51-0.70) and 0.62 (95% CI: 0.52-0.73) respectively. Overall, elevated HOXC6-DLX1 risk scores correlated with an increased risk of high-grade PCa detected on biopsy; 47% of men with a score >108 had significant cancer as compared to 6% with a risk score <17. Using a HOXC6-DLX1 risk score cut-off of 27.5 in the sPSA "grey-zone", 165 biopsies (31%) could have been avoided, and only 4% of patients with high-grade PCa would have been missed. Conclusions: The urine-based HOXC6-DLX1 assay provides a non-invasive solution to improve the selection of patients at increased risk for high-grade PCa who would benefit most from a prostate biopsy procedure, while reducing the number of unnecessary biopsies, particularly in the sPSA "grey-zone".

Validation of a two-gene mRNA urine test for detection of high-grade prostate cancer in German men.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 96-96
Author(s):  
Derya Tilki ◽  
Daphne Hessels ◽  
Geert Trooskens ◽  
Susan Mulders ◽  
Michael Brawer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Validation Study ◽  
Prostate Biopsy ◽  
Predictive Value ◽  
Clinical Performance ◽  
Unmet Need ◽  
High Grade ◽  
Grade Group ◽  
Increased Risk ◽  
Average Serum

96 Background: There is an unmet need for non-invasive methods that can accurately identify patients at increased risk for clinically significant prostate cancer (PCa). SelectMDx is a urine-based molecular test that has been clinically validated for the detection of high-grade PCa. We evaluated SelectMDx clinical performance in a cohort of German men undergoing initial prostate biopsy. Methods: The study population consisted of 443 men sequentially enrolled men who underwent initial prostate biopsy between July 2009 and December 2014 due to suspected PCa. Post-DRE urine was collected from all subjects prior to biopsy, and samples stored at -70C. Urinary HOXC6 and DLX-1 mRNAs were quantified by PCR in May 2018, and RNA results combined with clinical risk factors to determine the likelihood that biopsy would identify ISUP grade group (GG) ≥ 2 (Gleason Score ≥ 7) PCa. We assessed SelectMDx performance for detection of GG ≥ 2 PCa, compared to the PCPT Risk Calculator Version 2.0 (PCPTRC, http://myprostatecancerrisk.com , accessed Oct 7, 2018). Results: For the 443 subjects enrolled, average age was 66 years (median 66, interquartile range 61 to 71), and average serum PSA level 8.8 ng/mL (6.4, 4.8 to 9.7). Cancer was detected in 243/443 (55%) men biopsied (43% GG1, 36% GG2, 9% GG3 and 12% GG4-5). The prevalence of GG2-5 PCa in this population was 31.4% (139/443). For detection of GG2 or higher PCa versus GG1 or no PCa at biopsy, SelectMDx AUC was 0.82 (95% C.I. 0.78-0.86) and the PCPTRC yielded AUC 0.75 (0.70-0.80), P < 0.001. SelectMDx sensitivity was 94% (89-98%), specificity 46% (40-52%), positive predictive value 45% (42-47%) and negative predictive value (NPV) 95% (90-97%). If the initial biopsy had been performed based on SelectMDx results alone, 46% of potentially unnecessary biopsies and 34% of all biopsies would have been avoided, while 5.8% of men with biopsy-detectable high-grade PCa (seven GG2, one GG3) may have had their diagnosis delayed. Conclusions: In this first validation study of SelectMDx in German men, the test’s clinical performance was comparable to the published EU validation study, showing a high NPV for detection of GG2 or higher PCa. These results provide further evidence for the clinical validity of SelectMDx.

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