Indication For Prostate Biopsy Research Articles

Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency.

Due to a lack of time and staff, informed consent (IC) in clinical practice often lacks clarity, comprehensibility and scope of information. Digital media offer great potential to enhance IC. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC. In the randomized, controlled, three-arm DICon (Digital Informed Consent for urological surgery) study 70 patients with an indication for prostate biopsy were randomized 1:1:1 to receive traditional paper-based IC vs. multimedia-supported information before IC vs. multimedia-supported information during IC. Patient satisfaction, anxiety and information gain were measured by validated questionnaires 2 weeks and directly before the procedure and time efficiency was recorded. Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test). Multimedia information prior to the consultation saved 32.9% time compared to paper-based (5.3 min. vs. 9.5 min; p < 0.05) and 60.4% time compared to shared multimedia information (5.3 min. vs. 13.9 min.; p < 0.001), with no difference in satisfaction (62.6 vs. 62.7 vs. 68.6 of max. 80; p = 0.07), anxiety (8 vs. 8.1 vs. 7 of max. 16; p = 0.35), or information gain (6.5 vs. 5.7 vs. 6.7 of max. 10; p = 0.23). Results on satisfaction (56.6 vs. 62.6 vs. 66; p = 0.06), anxiety (7.2 vs. 7.2 vs. 6.8; p = 0.84), and information gain (7 vs. 6.4 vs. 5.9; p = 0.43) remained stable over time. Multimedia-supported IC prior to consultation provided improved time efficiency (33% gain) compared to traditional paper-based IC, with comparable satisfaction, anxiety and information gain. Multimedia-supported information materials should therefore be used more frequently in patient education.

How to avoid prostate biopsy in men with Prostate Image-Reporting and Data System 3 lesion? Development and external validation of new biopsy indication using prostate health index density.

To develop a customized prostate biopsy indication using prostate health index density (PHID) combined with multiparametric magnetic resonance imaging (mpMRI) and assess the reliability of the PHID cutoff value in external populations. A total of 521 cognitive MRI/ultrasonography fusion prostate biopsies and biomarker tests for prostate-specific antigen (PSA), free PSA, and PHI were performed after mpMRI. The predictive value for clinically significant prostate cancer (csPCa; Gleason score≥7) of PSA derivatives was examined using the ROC curve. We developed a new biopsy indication utilizing a PHID cutoff based on the Prostate Image-Reporting and Data System (PI-RADS) score, which was externally validated. The combination of PHID and mpMRI (AUC=0.884) demonstrated the highest predictive ability for csPCa, although PHID (AUC=0.843) and PI-RADS (AUC=0.806) individually also showed a high diagnostic value. When a PHID cutoff of 0.75 was used in men with PI-RADS 3 lesions, the negative predictive value of csPCa was 100%, and approximately half of the biopsies could be safely avoided. Compared to PHID or PI-RADS scores alone, the combination of PHID and PI-RADS scores increased the accuracy of csPCa detection and the number of cases in which biopsy could be avoided. In men with PI-RADS 3 lesions, the optimal PHID cutoff ≥0.75 can prevent half of the unnecessary biopsies without missing csPCa. In men with PI-RADS 4-5 lesions, biopsies are warranted regardless of PHID values because csPCa could be accompanied by low PHID.

Inherited risk for prostate cancer (PCa): Following the natural history of men with high-risk genetics using multiparametric MRI (mpMRI).

390 Background: PCa has inherited risk factors including high genetic risk variants such as BRCA1/2, HOXB13, and DNA mismatch repair genes. mpMRI has been shown to be effective for detection and staging of localized PCa. This study follows participants (prts), born biologically male, without a diagnosis of PCa with known germline pathogenic or likely pathogenic variants (PV) in BRCA1/2, MLH1, MSH2, MSH6, PMS2, EPCAM, HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C/D, BRIP1, or FANCA-FANCM (NCT03805919). Methods: Up to 500 eligible prts 30-75 years old (yo) with a documented germline PV will enroll. Prts undergo biennial clinical exam and mpMRI, and annual PSA monitoring and are followed at 12-month intervals to determine PSA, prostate cancer diagnosis, and/or disease/survival status until death. Indication for prostate biopsy includes clinical or imaging findings. Biopsy specimens undergo molecular analyses. Results: To date, 175 prts have been enrolled: 169 (97%) White, 3 Hispanic (2%), 1 African American (1%), 1 Asian (1%), and 1 biethnic (1%). Median age is 47 yo. The most common monoallelic PV are: 48.6% BRCA2, 25.1% BRCA1, 6.3% CHEK2 and 5.7% MSH2. PVs in ATM, PALB2, HOXB13, PMS2, MLH1, MSH6, BRIP1, EPCAM and RAD51D are ≤4%. One subject carries three distinct PVs ( BRCA2, CHEK2, BRIP1). Indication for biopsy was found in 26.3% of prts with 22/46 (47.8%) with a PIRADS 4 lesion, 6/46 (13.0%) PIRADS 3 lesion, 12/46 (26.1%) elevated PSA (median=2.8 ng/mL) or 6/46 (13.0%) due to clinical discretion. Adenocarcinoma was diagnosed on 13/39 (33.3%) biopsies with median age at diagnosis=59 yo. 9/13 (69%) prts had a PSA &lt;3 ng/ml at diagnosis. Nine prts were diagnosed with ISUP Grade Group (GG) 1, 3 with GG2, and 1 with GG3. Eight prts opted for active surveillance (AS), 2 for radiation therapy (RT), and 3 for prostatectomy (RP). Two prts on AS converted to definitive treatment (one RP and one RT) due to progression in GG on the year 1 AS biopsy. Conclusions: mpMRI screening in men with germline PV can be used for diagnosis and monitoring of PCa and facilitates detection below conventional PSA thresholds in a high genetic risk setting. Access to genetic testing and other variables need to be addressed in underrepresented minorities. Correlative studies, including cfDNA and PBMCs, are ongoing. Clinical trial information: NCT03805919 . [Table: see text]

Comparison of Single Versus Multiple Doses of Fluoroquinolone (Levofloxacin) for Prophylaxis in Prostate Biopsy

Objective: To assess the efficacy of Levofloxacin 500 mg orally for prophylaxis in transrectal prostate biopsy guided by ultrasonography compared to three dosages. Study design: A comparative study Place and Duration: this study was done in Murshid Hospital and Health Care Centre Karachi from September 2021 to September 2022 Methodology: A total of 615 patients having the typical indications for prostate biopsy performed under transrectal ultrasonography guidance (increased PSA, abnormal digital rectal examination) were included in this study. Overall 425 patients were considered qualified for participation; using Graph Pad Prism 6.0, patients were assigned to one of two groups using random assignment, 205 individuals in Group A were given one oral dosage of 500 mg of levofloxacin 60 to 120 minutes before the procedure, Likewise, 220 patients in Group B received Levofloxacin (500 mg) once per 24 hours for two days before to the procedure as well as the day of it. Results: Patients in Group A were given orally a single dose of levofloxacin 500 mg there were 205 patients in this group. These individuals were diagnosed with diabetes mellitus (DM) at a rate of 43.9%, febrile urinary tract infections at a rate of 4.3%, and sepsis at a rate of 0.97%.In this group, 65.80cc,was the average prostate volume, and 90.17% were overweight.A total of 220 patients in groupB who received orally three doses of levofloxacin 500 mg, with an average age of 67.45 years and a PSA mean of 21.26 ng/mL; 31.8% of patients had diabetes mellitus, &amp; 4.45% had a febrile urinary tract infection (FUTI). In this group, no patients had sepsis, 75.61 cc was the mean prostate volume, and 72.74% of the patients were overweight, as in Group A. Conclusion: Because of how effective it is, a single dose of levofloxacin containing 500 milligrams is an excellent option for prophylaxis in patients who are going to have a transrectal prostate biopsy. Keywords: transrectal biopsy, flroquinolone, prophylaxis

Impact of virtual reality on pain management in transrectal MRI-guided prostate biopsy.

The beneficial effect of virtual reality (VR) on pain management in the context of transrectal MRI-guided prostate biopsy is not well established. However, it remains unclear whether an adjunctive of VR also improves pain management. This study aimed to evaluate the impact of VR as adjunctive in pain management in transrectal MRI-guided prostate biopsy (PB). We retrospectively evaluated the pain intensity incidence in the 153 patients with PB indication (of which 102 were naïve of PB) who were admitted to our hospital since the acquisition of the Healthy Mind virtual reality headset on 19 January 2021. Baseline characteristics of patients who received local anesthesia with 1% lidocaine periprostatic nerve block (PPNB) (Group SOC, N = 78) and patients who received VR associated with PPNB (Group VR, N = 75) were largely similar. One PB with general anesthesia was excluded. The mean pain score at day zero was respectively 3.4 (±2.5) and 2.9 (±2.3) for SOC and VR (p = 0.203). However, the mean pain score at day zero was significantly lower in naïve PB patients with VR [2.7 (±2.0)] than in naïve PB patients with SOC [3.8 (±2.5), p = 0.012] when patients were stratified in PB status. Similar results were found on day 3 for the analysis including naïve-PB patients with SOC vs. with VR [0.4 (±2.5) vs. 0.2 (±2.0); p = 0.023)]. The pain intensity was significantly lower in naïve PB patients with VR than in naïve PB patients with SOC. There were no side effects from VR and tolerability was excellent.

Urinary Zinc Loss Identifies Prostate Cancer Patients.

Prostate Cancer (PCa) is one of the most common malignancies in men worldwide, with 1.4 million diagnoses and 310,000 deaths in 2020. Currently, there is an intense debate regarding the serum prostatic specific antigen (PSA) test as a diagnostic tool in PCa due to the lack of specificity and high prevalence of over-diagnosis and over-treatments. One of the most consistent characteristics of PCa is the marked decrease in zinc; hence the lost ability to accumulate and secrete zinc represents a potential parameter for early detection of the disease. We quantified zinc levels in urine samples collected after a standardized prostatic massage from 633 male subjects that received an indication for prostate biopsy from 2015 and 2019 at AOU Città della Salute e della Scienza di Torino Hospital. We observed that the mean zinc levels were lower in the urine of cancer patients than in healthy subjects, with a decreasing trend in correlation with the progression of the disease. The combination of zinc with standard parameters, such as PSA, age, digital rectal exploration results, and magnetic resonance findings, displayed high diagnostic performance. These results suggest that urinary zinc may represent an early and non-invasive diagnostic biomarker for prostate cancer.

An Analysis of Prostate Biopsy Results at the Cape Coast Teaching Hospital, Ghana

Introduction: Prostate cancer is the commonly diagnosed male cancer worldwide. The best technique for the diagnosis of prostate cancer is prostate biopsy. Transrectal ultrasound (TRUS)-guided biopsy of the prostate enhances early diagnosis of prostate cancers. Objective: The aim of the study is to describe the clinical and pathological characteristics of Prostate cancers as seen at the Cape Coast Teaching Hospital Materials and Methods: A total of 62 patients who underwent TRUS-guided prostatic biopsy over a period of 3 years (January 2019- December 2021) participated in the study. Their data were analyzed retrospectively using the archives of the pathology department of the Cape Coast Teaching Hospital. Results: Of the 62 patients who underwent TRUS-guided prostrate biopsy from January 2019 to December 2021, their mean age was 68.3 with an age range of 34-89 years. 67.7% had adenocarcinoma of the prostate, 1.6% had spindle cell cancer, 24.2% had benign prostate hyperplasia and 6.5% had chronic prostatitis. Conclusion: The indications for prostate biopsy in our center detect more patients with prostate cancer than other prostate pathologies. The serum PSA significantly correlated with the Gleason grade.

Positive urine culture prior to transrectal prostate biopsy was not associated with infectious complications development.

Prostate cancer is one of the most common cancers worldwide. Its histological diagnosis is based on prostate biopsy. The transrectal procedure is one of the most common procedures performed by urologists. Although it is considered safe, post-biopsy infectious complications are frequently observed in practice. The aim of this study is to investigate the value of urine culture before the transrectal biopsy. Secondly, we assessed potential risk factors for infectious complications following TR-PB. We performed a retrospective analysis of all patients who underwent urine culture tests before transrectal prostate biopsy between January 2019 and July 2020. The inclusion criteria for the study were all indications for prostate biopsy (PSA>4ng/mL or abnormal digital rectal examination). Baseline characteristics and the incidence of post-biopsy urinary tract infection were compared between patients showing positive pre-biopsy culture results and those showing negative findings. Multivariate logistic regression analyses were used to determine risk factors for infectious complications following TR-PB. Out of 163 patients included in our study, 19 patients (11.65%) had positive urine culture results before the biopsy. Age (P=0.068); history of hospitalization (P>0.999), history previous of quinolone use (P=0.75), history of UTI (P=0.64); median PSA level at diagnosis (P=0.267); prostate volume (P=0.78); post-void residual volume (P=0.374); percentage of patients testing positive for cancer on biopsy (P=0.81); and percentages of patients with a history of biopsy (P=0.889), diabetes mellitus (P=0.524), hypertension (P=0.714) and immunosuppressive medication use (P>0.999) were similar between the two groups. One patient in the positive urine culture group had post-biopsy prostatitis. However, 3.24% (five patients) of the negative urine culture group had the disease (P=0.789) (four patients with prostatitis and one with epididymitis). Among them, four patients were diagnosed by urine culture at the time of post-biopsy urinary tract infection. Multivariate logistic regression analysis demonstrated that history of hospitalization and history of previous quinolone use were risk factors for infection after transrectal prostate biopsy. Our study suggests that systematically performing urine cultures before transrectal prostate biopsy does not reduce the rate of infectious complications after biopsy. Positive pre-biopsy cultures were not associated with the development of post-biopsy infectious complications.

A SelectMDx/magnetic resonance imaging-based nomogram to diagnose prostate cancer.

70%-80% of prostate cancer (PCa) biopsies performed in the US annually may be unnecessary. Specific antigen testing (PSA) and tans rectal ultrasound (TRUS) are imprecise predictive methods for risk of PCa. Novel strategies are critical to guide biopsy decision-making. We assessed the utility and accuracy of combining Select MDx and multiparametric magnetic resonance imaging (mpMRI) scores for predicting risk of PCa. Our study was conducted at Mount Sinai hospital at Urology department in New York City from January 2020 to April 2021. Total 129 men performed select MDx test. Indications for prostate biopsy were high-risk Select MDx score, suspicious DRE, PI-RADS scores 3/4/5 on mpMRI, or any combination of these. Fifty-one percentage of 129 patients underwent systemic or combined systemic and MRI/US (ultrasound) fusion biopsy; All men underwent 3 T MRI of Prostate w/wo contrast using standard protocols prior to biopsy. A single surgeon performed prostate biopsies. Gleason score ≥3+3 on biopsy is defined as outcome. Descriptive statistics were calculated as cross tables. Binary logistic regression model is used to determine the outcome. The nomogram was based on the coefficients of the logit function. ROCs were plotted and decision curve analysis was performed. Using both high-risk Select MDx and PI-RADS scores of 4/5, 87% of biopsies could have been avoided, while detecting 64% of PCa and missing 36%. If biopsies were performed on men with positive Select MDx or PI-RADS 4/5 results, 16% of biopsies could have been avoided while detecting all PCa. Combining these scores improved specificity and accuracy for the detection of PCa over either used alone. Study limitations include limited sample size, sole institution study, and risk or overfitting for the proposed model which may limit generalizability. Combining SelectMDx and mpMRI PI-PADS scores of 4/5 may be useful for PCa biopsy decision-making.

MP32-11 FREE-HAND VERSUS GRID-ASSISTED TRANSPERINEAL ULTRASOUND MRI-FUSION PROSTATE BIOPSY: AN INITIAL EXPERIENCE

You have accessJournal of UrologyCME1 May 2022MP32-11 FREE-HAND VERSUS GRID-ASSISTED TRANSPERINEAL ULTRASOUND MRI-FUSION PROSTATE BIOPSY: AN INITIAL EXPERIENCE Jacob Enders, Nicole Varble, Michael Rothberg, Zach Kozel, Sheng Xu, Patrick Gomella, Michael Daneshvar, Reza Seifabadi, Maria Merino, Baris Turkbey, Bradford Wood, and Peter Pinto Jacob EndersJacob Enders More articles by this author , Nicole VarbleNicole Varble More articles by this author , Michael RothbergMichael Rothberg More articles by this author , Zach KozelZach Kozel More articles by this author , Sheng XuSheng Xu More articles by this author , Patrick GomellaPatrick Gomella More articles by this author , Michael DaneshvarMichael Daneshvar More articles by this author , Reza SeifabadiReza Seifabadi More articles by this author , Maria MerinoMaria Merino More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Bradford WoodBradford Wood More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002581.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Transperineal (TP) prostate biopsy has been shown to reduce rates of bleeding, sepsis, and other infectious complications compared to the traditional transrectal (TR) approach. Recent efforts have focused on using free-hand TP ultrasound (US) rather than TRUS for TP biopsy, with the objective of facilitating prostate biopsies in patients with post-TRUS biopsy urosepsis or in those without a rectum. We sought to compare cancer detection and upgrading rates between free-hand TPUS TP biopsy versus grid-assisted TP biopsy with TRUS. METHODS: Patients with an indication for prostate biopsy were enrolled in an IRB-approved clinical trial at our institution and underwent multiparametric MRI (mpMRI) of the prostate prior to biopsy. Under monitored anesthesia care or deep sedation, patients were placed in the dorsal lithotomy position. Registration of 2D TPUS sweeps with mpMRI was performed and, using the UroNav platform (Invivo/Philips, Gainesville, FL), two biopsy cores per MR-visible target lesion were obtained via the free-hand TPUS TP biopsy and grid-assisted TP biopsy with TRUS guidance techniques. A modified Barzell scheme was then used for systematic TP biopsy. Clinically significant prostate cancer was defined as Gleason grade group 2 or higher. Concordance of pathology of targeted biopsy cores and rates of upgrading between free-hand and grid-assisted TP biopsy techniques were compared. RESULTS: 49 patients have undergone free-hand and grid-assisted TP biopsy at our institution. 33/49 patients (67.3%) with a median PSA of 7.3 ng/mL (IQR: 5.2 – 11.0) were positive for cancer on biopsy. The mean number of cores obtained from targeted lesions per patient was 5.0±2.2 for the grid-assisted technique and 3.8±2.1 with free-hand technique. 40% and 34% of targeted cores were positive on grid-assisted and free-hand TP biopsy, respectively. 17/49 patients (34.7%) had a higher grade cancer on grid-assisted than free-hand biopsy, and in 6 cases this discordance was clinically significant. There were zero infection-related complications following the procedure. CONCLUSIONS: Free-hand TP prostate biopsy with TPUS guidance allows for diagnosis of prostate cancer with comparable rates to the grid assisted TP biopsy technique with TRUS. This may facilitate biopsies in patients who have had prior post-TRUS biopsy urosepsis or in patients without a rectum. Further work is necessary to refine needle placement with the free-hand technique to ensure accurate lesion sampling and validate the technique in a larger patient cohort. Source of Funding: The National Institute of Health (NIH) Medical Research Scholars Program, Foundation for the NIH, NIH Intramural Research Program © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e535 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jacob Enders More articles by this author Nicole Varble More articles by this author Michael Rothberg More articles by this author Zach Kozel More articles by this author Sheng Xu More articles by this author Patrick Gomella More articles by this author Michael Daneshvar More articles by this author Reza Seifabadi More articles by this author Maria Merino More articles by this author Baris Turkbey More articles by this author Bradford Wood More articles by this author Peter Pinto More articles by this author Expand All Advertisement PDF DownloadLoading ...

Comparing Micro-Ultrasound to mpMRI in Detecting Clinically Significant Prostate Cancer

Objectives To compare the performance of micro-ultrasound (mUS) with multi-parametric magnetic resonance imaging (mpMRI) in detecting clinically significant prostate cancer. Materials and Methods Retrospective data from consecutive patients with any indication for prostate biopsy in 2 academic institutions were included. The operator, blinded to mpMRI, would first scan the prostate and annotate any mUS lesions. All mUS lesions were biopsied. Any mpMRI lesions that did not correspond to mUS lesion upon unblinding were additionally biopsied. Grade group (GG) ≥ 2 was considered clinically significant cancer. The Jeffreys interval method was used to compare performance of mUS with mpMRI with the non-inferiority limit set at −5%. Results Imaging and biopsy were performed in 82 patients with 153 lesions. mUS had similar sensitivity to mpMRI (per-lesion analysis: 78.4% versus 72.5%), but lower specificity, positive predictive value, negative predictive value, and area under the curve. Micro-ultrasound found GG ≥ 2 in 13% of cases missed by mpMRI, while mpMRI found GG ≥ 2 in 11% of cases missed by mUS. The difference 0.020 (95% CI −0.070 to 0.110) was not statistically significant (P = 0.33). Conclusion The sensitivity of mUS in detecting GG ≥ 2 disease was similar to that of mpMRI, but the specificity was lower. Further evaluation with a larger sample size and experienced operators is warranted.

ROLE OF POVIDONE-IODINE-SOAKED GAUZE IN PREVENTING INFECTIOUS COMPLICATIONS FOLLOWING TRANS RECTAL DIGITAL GUIDED PROSTATE BIOPSY

Objective: To identify the role of povidone iodine-soaked gauze following transrectal digital guided prostate biopsy in the prevention of infectious complications. Methodology: This prospective comparative study was conducted in the urology department of Lady Reading Hospital including 201 patients. Patients who had indications for prostate biopsy, including an elevated pros­tate-specific antigen (PSA) or abnormal prostatic nodule on digital rectal findings were included. Patients were distributed into two groups by the closed envelop method. Group, I (n=101) received a povidone-iodine-soaked gauze intrarectally along with xylocaine lubricant for 5 minutes just before biopsy, while group 2 (n=100) did not receive povidone-soaked gauze. The transrectal digital guided prostate biopsy guided method was used in this study. The rectal swab was taken before using povidone-soaked gauze and after doing biopsy in both groups The bacterial colonies were counted in swabs before using povidone-soaked gauze and after biopsy using biopsy Mueller-Hinton agar medium. Results: The mean age of group 1 was 64 years (range, 39–80) and group 2 was 61.7 years (range, 35–82). The average PSA values were 7.3 ng/ml and 8.34 ng/ml in groups 1 and 2, respectively. The rate of infectious complications in group1 was 0.9% (n=1) whereas in group 2 was 10% (n=10). A single-use of povidone-soaked rectal gauze significantly lowered the risk of infectious complications P&lt;0.05. There was a 99.9% decrease in the mean number of colony-forming units after rectal preparation. Conclusion: Findings concluded that using povidone iodine-soaked gauze before doing digital guided prostate biopsy is a significant method to minimize complications.

Saddle Block for Transrectal Prostate Biopsy: A Comparison of the Analgesic Efficacy of 0.25% Bupivacaine and 0.375% Ropivacaine

Background: Prostate biopsy is a painful procedure, and the degree of pain is related to the number of core biopsies taken.&#x0D; Objective: To compare the analgesic properties of hyperbaric bupivacaine 0.25% with 0.375% ropivacaine for saddle block in transrectal prostate biopsy.&#x0D; Methods: This was a randomised double-blinded study. Eighty patients with indications for prostate biopsy presenting at the Day-Case Theatre in a Nigerian tertiary facility were randomised into two equal groups: B (Bupivacaine) and R (Ropivacaine). Group B received 1ml of 0.25% bupivacaine, while Group R received 1ml of 0.375% ropivacaine for saddle block, respectively. Pain assessment, home readiness, patients' satisfaction, and time to first analgesic request were assessed and compared between the two groups.&#x0D; Results: The Bupivacaine group had an earlier onset of sensory block (11.90±4.10 minutes vs 23.70±8.65 minutes, p = 0.000), slower sensory block regression (48.73±9.32 minutes vs 24.88±4.21 minutes, p = 0.000), but delayed home readiness (47.23±15.93 minutes vs 29.88±8.58 minutes, p = 0.000), than patients in the Ropivacaine group. The pain scores during, immediately after and 30 minutes post-biopsy were lower in the Bupivacaine group: p = 0.010, p = 0.028 and p = 0.023 respectively. The time to first analgesic request was also longer in the Bupivacaine group (48.73±9.33 minutes) than for those in the Ropivacaine group (24.88±4.21 minutes) with statistical significance (p = 0.000).&#x0D; Conclusion: Intraoperative analgesic properties were better in the Bupivacaine group than in the Ropivacaine group. However, home readiness was earlier in the Ropivacaine group.

Abstract 2605: A natural history study of men with high-risk genetics for prostate cancer (PCa) using multiparametric MRI (mpMRI)

Abstract Introduction: The understanding of molecular genetics in PCa provides insight into disease progression and treatment. Less is known about PCa development in men with known high-risk germline pathogenic/likely pathogenic variants in PCa related genes, particularly DNA damage repair (DDR). mpMRI can localize and detect PCa lesions in this population. We are conducting a multicenter natural history study of male participants (prts) with documented germline variant(s) in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51D, BRIP1, or FANCA who do not have a PCa diagnosis using mpMRI (NCT03805919). Methods: Up to 500 men, 30-75 years old (y/o) will undergo mpMRI evaluation at baseline and every 2 years (yrs). Prts are followed at 12-mo intervals to determine PSA, PCa diagnosis, and/or disease/survival status until death. Indication for prostate biopsy includes PSA &amp;gt;2.0 for 30 - 49 y/o; &amp;gt;2.5 ng/mL for 50 - 75 y/o and/or PIRADS 3+ MRI lesion or clinical discretion. Tissue obtained will undergo full transcriptome analysis. Results: 100 prts have enrolled. Median age is 47 y/o. Median on-study PSA is 0.87 (0.16-10.05 ng/mL). Median PSA density is 0.029. Gene mutations are BRCA2 (40%), BRCA1 (33%), MSH2 (9%), and CHEK2 (4%). Mutations in ATM, HOXB13, MLH1, MSH6, PMS2, and EPCAM are ≤3%. No significant AEs have been observed. Of 96 prts, 25 (26%), had indication for biopsy [PIRADS 4 lesion: 16 (64%), PIRADS 3 lesion: 4 (16%), elevated PSA: 6 (24%), or clinical indication 1: (4%)]. 22 prostate biopsies were performed and 6 prts were diagnosed with PCa. One prt was upstaged on radical prostatectomy (RP). Conclusions: We found mpMRI-based PCa screening in men with high-risk gene mutations, especially DDR genes, is feasible and can be used to identify clinically significant PCa and monitor for disease progression. Future guidelines should consider age, mutation specificity and mpMRI. Accrual and correlative studies (biomarkers, PBMCs) are on-going. AgeMutationPSA (ng/mL)Biopsy Gleason ScoreTreatment65BRCA22.253+3RP52BRCA10.693+3Active Surveillance (AS)62CHEK22.493+3AS59PMS21.033+3AS59CHEK22.243+4Radiation55BRCA21.683+3RP: 4+4=8 Citation Format: Fatima Karzai, Anna Couvillon, Yolanda McKinney, Katherine Lee-Wisdom, Peter L. Choyke, Veda N. Giri, Todd M. Morgan, Heather H. Cheng, Maria J. Merino, Peter A. Pinto, Baris Turkbey, William L. Dahut. A natural history study of men with high-risk genetics for prostate cancer (PCa) using multiparametric MRI (mpMRI) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2605.

Rotterdam mobile phone app including MRI data for the prediction of prostate cancer: A multicenter external validation

ObjectivesThe Rotterdam Prostate Cancer Risk calculator (RPCRC) has been validated in the past years. Recently a new version including multiparametric magnetic resonance imaging (mpMRI) data has been released. The aim of our study was to analyze the performance of the mpMRI RPCRC app. MethodsA series of men undergoing prostate biopsies were enrolled in eleven Italian centers. Indications for prostate biopsy included: abnormal Prostate specific antigen levels (PSA>4 ng/ml), abnormal DRE and abnormal mpMRI. Patients’ characteristics were recorded. Prostate cancer (PCa) risk and high-grade PCa risk were assessed using the RPCRC app. The performance of the mpMRI RPCRC in the prediction of cancer and high-grade PCa was evaluated using receiver operator characteristics, calibration plots and decision curve analysis. ResultsOverall, 580 patients were enrolled: 404/580 (70%) presented PCa and out of them 224/404 (55%) presented high-grade PCa. In the prediction of cancer, the RC presented good discrimination (AUC = 0.74), poor calibration (p = 0.01) and a clinical net benefit in the range of probabilities between 50 and 90% for the prediction of PCa (Fig. 1). In the prediction of high-grade PCa, the RC presented good discrimination (AUC = 0.79), good calibration (p = 0.48) and a clinical net benefit in the range of probabilities between 20 and 80% (Fig. 1). ConclusionsThe Rotterdam prostate cancer risk App accurately predicts the risk of PCa and particularly high-grade cancer. The clinical net benefit is wide for high-grade cancer and therefore its implementation in clinical practice should be encouraged. Further studies should assess its definitive role in clinical practice.

SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study.

Simple SummaryProstate-specific antigen and digital rectal examination, used to guide prostate biopsy, often result in overdiagnosis of indolent prostate cancer (PCa) while missing clinically significant PCa (csPCa). The aim of this study was to evaluate the diagnostic accuracy of SelectMDx and its association with multiparametric magnetic resonance imaging (mpMRI) in predicting PCa in prostate biopsies. SelectMDx was revealed to be a good predictor of PCa, while with regards to csPCa detection, it was demonstrated to be less effective, showing results similar to mpMRI. The best diagnostic strategy to avoid unnecessary biopsy is performing SelectMDx after an initial negative mpMRI. Biopsy could be proposed for all cases of positive mpMRI and to those with a negative mpMRI followed by a positive SelectMDx.Prostate-specific antigen (PSA) testing as the sole indication for prostate biopsy lacks specificity, resulting in overdiagnosis of indolent prostate cancer (PCa) and missing clinically significant PCa (csPCa). SelectMDx is a biomarker-based risk score to assess urinary HOXC6 and DLX1 mRNA expression combined with traditional clinical risk factors. The aim of this prospective multi-institutional study was to evaluate the diagnostic accuracy of SelectMDx and its association with multiparametric magnetic resonance (mpMRI) when predicting PCa in prostate biopsies. Overall, 310 consecutive subjects were included. All patients underwent mpMRI and SelectMDx prior to prostate biopsy. SelectMDx and mpMRI showed sensitivity and specificity of 86.5% vs. 51.9%, and 73.8% vs. 88.3%, respectively, in predicting PCa at biopsy, and 87.1% vs. 61.3%, and 63.7% vs. 83.9%, respectively, in predicting csPCa at biopsy. SelectMDx was revealed to be a good predictor of PCa, while with regards to csPCa detection, it was demonstrated to be less effective, showing results similar to mpMRI. With analysis of strategies assessed to define the best diagnostic strategy to avoid unnecessary biopsy, SelectMDx appeared to be a reliable pathway after an initial negative mpMRI. Thus, biopsy could be proposed for all cases of mpMRI PI-RADS 4–5 score, and to those with Prostate Imaging-Reporting and Data System (PI-RADS) 1–3 score followed by a positive SelectMDx.

Association of local anesthetic method and prostate volume with the occurrence of prostate biopsy complications

Background: Due to the invasive nature of prostate biopsy, it is associated with various complications. The study aimed to determine the association of local anesthetic method and prostate volume with the occurrence of these prostate biopsy complications. Materials and Methods: It was a prospective study carried out in 106 patients with indications for prostate biopsy. They were randomized into two equal groups receiving either intrarectal lidocaine gel or periprostatic nerve block. Prostate volume was determined using transrectal ultrasound, and patients were further divided into three prostate volume classes (20-40 ml, 40-100 ml, and ≥100 ml). Systematic sextant prostate biopsy was done, and the occurrence of complications (pain, bleeding, infection, and urinary retention) was documented. Data were analyzed using the Statistical Package for the Social Sciences (SPSS) software. Results: The pain scores of patients were similar irrespective of their prostate volume even with the use of different types of anesthesia. There was no significant tendency for the occurrence of bleeding, infection, and voiding complications when periprostatic nerve block or intrarectal lidocaine gel was used for pain relief. Postbiopsy cystourethritis was, however, significantly associated with the volume of the prostate (P = 0.006). Conclusion: The choice of local anesthesia does not affect the occurrence of complications following transrectal prostate biopsy. There is, however, a significant potential for the development of postbiopsy cystourethritis in patients with larger prostates.

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy.

ObjectivesTo study high‐frequency 29 MHz transrectal side‐fire micro‐ultrasound (micro‐US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro‐US imaging of the prostate.Materials and methodsA prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro‐US vs conventional end‐fire ultrasound (conv‐US) transrectal‐guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro‐US image interpretation protocol that was developed during the trial using data from the pre‐training micro‐US arm. Investigators received a standardized training program mid‐trial, and the post‐training micro‐US data were used to examine the training effect.ResultsDetection of csPCa (the primary outcome) was no better with the first‐generation micro‐US system than with conv‐US in the overall population (34.6% vs 36.6%, respectively, P = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI‐MUS in order to address the lack of understanding of the appearance of cancer under micro‐US. Micro‐US sensitivity in the post‐training group improved to 60.8% from 24.6% (P < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro‐US arm increased by 7% after training (32% to 39%, P < .03), but training instituted mid‐trial did not affect the overall results of the comparison between arms.ConclusionMicro‐US provided no clear benefit over conv‐US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first‐generation system.

The role of immune PSA complex (iXip) in the prediction of prostate cancer

Purpose To analyse the performance of iXip in the prediction of prostate cancer (PCa) and high-grade PCa. Methods A consecutive series of men undergoing MRI/FUSION prostate biopsies were enrolled in one centre. Indications for prostate biopsy included abnormal prostate-specific antigen (PSA) levels (PSA > 4 ng/ml) and/or abnormal digital rectal examination (DRE) and/or abnormal MRI. All patients underwent the evaluation of serum PSA-IgM concentration and the iXip ratio was calculated. Accuracy iXip for the prediction of PCa was evaluated using multivariable binary regression analysis and receiver operator characteristics (ROC) curves. Results Overall 160 patients with a median age of 65 (62/73) years were enrolled. Overall, 42% patients were diagnosed with PCa and 75% of them had high-grade cancer (Epstein ≥ 3). Patients with PCa were older and presented higher PSA levels, higher PIRADS scores and lower prostate volumes (PVs). On ROC analysis iXip presented an area under the curve (AUC) of 0.57 in the prediction of PCa and of 0.54 for the prediction of high-grade PCa. Conclusions In our experience, immune PSA complexes are not predictors of PCa. iXip analysis should not be included in the diagnostic pathway of patients at increased risk of PCa.

Occurrence of Carcinoma Prostate in Different Levels of Serum PSA ≥ 2.5 NG/ML in Bangladesh

Background: Prostate cancer is the most common cancer in men. Serum prostatespecific antigen (PSA) is the screening test for the prostate cancer. This test is usually done for the first step in any prostate cancer diagnosis. Prostate biopsy is the procedure for final diagnosis of carcinoma prostate. Objective: To detect the occurrence of prostate cancer at different level of serum PSA ≥2.5ng/ml Method: This hospital based cross sectional analytical study was conducted between the periods of January 2012 to April 2013. A total of 105 patients with features of lower urinary tract symptoms with enlarged prostate attending to the Department of Urology, National Institute of Kidney Diseases &amp; Urology (NIKDU), Sher-E-Bangla Nagar, Dhaka were purposively selected as study population. Patients more than 50 years old with lower urinary tract symptoms at S. PSA level ≥ 2.5 ng/ml and enlarged prostate in DRE were selected as study population. Patients with bleeding disorder, anorectal pathology, active UTI or prostatitis or urethral stricture were excluded from this study. DRE was done to see the size, consistency and nodularity of prostate. Those who had enlarged prostate found on DRE having S. PSA levele” 2.5 ng/ml, they were sent for biopsy. Result: The mean age of the patients was 66.87±10.13 years with a range of 51-92 years. Among 105 patients 19 (18.10%) were in the age group of 51-60 years, 35 (33.33%) were in the age group of 61 - 70 years, 27 (25.71%) were in the age group of 71 - 80 years and 24 (22.86%) were in the age group &gt;80 years. Among 105 patients 45 (42.9%) had malignant lesion and 60 (57.10%) had benign lesion. Mean serum PSA level among the patients with histopathological findings benign and malignant were 7.87±5.18 and 27.42±22.25 ng/ ml respectively. Out of 45 patients with malignant lesion, 3(16.7%) had serum PSA level within 2.50-2.99 ng/ml, another 5(14.3%) had 4.00-9.99 ng/ml, 11(56.0%) had serum PSA level within 10.00-20.00 ng/ml and 26(57.8%) There is a statistically significant difference observed in serum PSA level among the patients with histopathological findings benign and malignant (P&lt;0.001). Conclusion: For early diagnosis of prostate cancer cut-off value of serum PSA≥ 2.5 ng/ ml may be used as an indication for prostate biopsy. Bangladesh Journal of Urology, Vol. 20, No. 1, January 2017 p.13-17