Non-infectious adverse events of transperineal prostate biopsies performed under local anaesthesia.

OBJECTIVE: To report non-infectious adverse events associated with transperineal prostate biopsy (TPBx) performed under local anaesthesia (LA) in an outpatient setting. PATIENTS AND METHODS: This study reports secondary outcomes from the Norwegian arm of the prospective NORAPP study (ClinicalTrials.gov identifier NCT04146142) and included all patients referred for prostate biopsy from November 2019 to February 2021. Transperineal magnetic resonance imaging-transrectal ultrasonography fusion TPBx were taken using 40 mL 1% lidocaine with 4 mL of 8.4% sodium bicarbonate placed in the perineal skin, under the prostatic apex, in the m. levator ani bilaterally, and along the path of the needle. Follow-up using patient-reported questionnaires was done immediately after TPBx, and after 2 weeks and 2 months. Pain was reported using a visual analogue scale (VAS) during placement of the LA, and during and after TPBx. Haematuria and acute urinary retention (AUR) rates were recorded. RESULTS: We included 402 patients, and the response rate was 99.8% (401/402). The median (interquartile range [IQR]) age was 69 (63-74) years, the prostate volume was 40 (27-58) mL, the prostate-specific antigen level was 7.0 (4.5-11) ng/mL, and the number of biopsy cores taken was 8 (6-10). The median (IQR) VAS pain score was 1 (1-2) during placement of LA, 1 (0-2) during TPBx, and 0 (0-0) after TPBx. Haematuria and AUR rates were 64% (95% confidence interval [CI] 60-69%) and 0.5% (95% CI 0.1-1.8%), respectively. No patients were hospitalised or required after the TPBx surgical intervention. CONCLUSION: Transperineal prostate biopsies can be performed under LA with limited discomfort to the patient and few post-TPBx adverse events.

Computed tomography for visible haematuria - a single nephrographic phase is sufficient for detecting renal cell carcinoma.

OBJECTIVES: No previous studies have compared two computed tomography (CT) protocols in patients presenting with visible haematuria, and most patients undergo a multiphase CT in order to detect upper tract malignancies. We aimed to prospectively compare the diagnostic performance of single- and four-phase CT for detecting renal cell carcinoma (RCC) in patients with visible haematuria. MATERIALS & METHODS: 'A Prospective Trial for Examining Hematuria using Computed Tomography' (PROTEHCT) was a single-centre prospective paired diagnostic study in patients referred for CT due to painless visible haematuria between September 2019 and June 2021. All patients underwent four-phase CT (control) from which a single nephrographic phase dual energy CT (experimental) was extracted. Both were independently assessed for RCC by randomised radiologists. Histologically verified RCC defined a positive reference standard. Follow-up ascertainment of RCC diagnosis was completed in May 2022. Descriptive statistics were used to calculate the accuracies. Inter-reader agreement was assessed by kappa statistics. RESULTS: A total of 308 patients (median age, 68 years [interquartile range 53-77, range 18-96], 250 males) were included for analysis. RCC was diagnosed in seven (2.3%) patients during a median follow-up time of 19 months (interquartile range: 15-25). For the control and experimental CT, sensitivity was 100% versus 100%, specificity was 97% versus 98% and accuracy 97% versus 97%. The positive predictive value was 44% versus 50%, and the negative predictive value was 100% versus 100%. The agreement between the control and experimental CT was 98% (k = 0.79). CONCLUSION: A single nephrographic phase dual energy CT is sufficient for detecting RCC in patients with visible haematuria.

Is a Single Nephrographic Phase Computed Tomography Sufficient for Detecting Urothelial Carcinoma in Patients with Visible Haematuria? A Prospective Paired Noninferiority Comparison.

Background: There is uncertainty about the utility of multiphase computed tomography (CT) compared with single-phase CT in the routine examination of patients with visible haematuria (VH). Objective: To compare the accuracies of single nephrographic phase (NP) CT and four-phase CT in detecting urothelial carcinoma (UC). Design setting and participants: This was a single-centre, prospective, paired, noninferiority study of patients with painless VH referred for CT before cystoscopy between September 2019 and June 2021. Patients were followed up for 1 yr to ascertain UC diagnosis. Intervention: All patients underwent four-phase CT (control), from which single NP CT (experimental) was extracted. Both were independently assessed for UC. Outcome measurements and statistical analysis: The primary outcome was the difference in accuracy between the control and experimental CT using a 7.5% noninferiority limit. Histologically verified UC defined a positive reference standard. Secondary outcomes included differences in sensitivity, specificity, negative (NPV) and positive (PPV) predictive values, and area under the curve (AUC). All results are reported per patient. Results and limitations: Of the 308 patients included, UC was diagnosed in 45 (14.6%). The difference in accuracy between the control and experimental CT was 1.9% (95% confidence interval -2.8 to 6.7), demonstrating noninferiority. Sensitivity was 93.3% versus 91.1%, specificity was 83.7% versus 81.8%, NPV was 98.7% versus 98.2%, PPV was 49.4% versus 46.1%, and AUC was 0.96 versus 0.94 for the control versus experimental CT. Limitations included a low number of UC cases and no definite criteria for selecting a noninferiority limit. Conclusions: The accuracy of NP CT is not inferior to that of four-phase CT for detecting UC. Patient summary: This study shows that a computed tomography (CT) examination with only one contrast phase is no worse than a more complex CT examination for detecting cancer in the urinary tract among patients presenting with visible blood in the urine.

Validating the screening criteria for bone metastases in treatment-naïve unfavorable intermediate and high-risk prostate cancer - the prevalence and location of bone- and lymph node metastases.

OBJECTIVE: The European Association of Urology (EAU) recommends a bone scan for newly diagnosed unfavorable intermediate- and high-risk prostate cancer. We aimed to validate the screening criteria for bone metastases in patients with treatment-naïve prostate cancer. METHODS: This single-center retrospective study included all patients with treatment-naïve unfavorable intermediate- or high-risk prostate cancer. All underwent MRI of the lumbar column (T2Dixon) and pelvis (3DT2w, DWI, and T2 Dixon). The presence and location of lymph node and bone metastases were registered according to risk groups and radiological (rad) T-stage. The risk of lymph node metastases was assessed by odds ratio (OR). RESULTS: We included 390 patients, of which 68% were high-risk and 32% were unfavorable intermediate-risk. In the high-risk group, the rate of regional- and non-regional lymph node metastases was 11% and 6%, respectively, and the rate of bone metastases was 10%. In the unfavorable intermediate-risk group, the rate of regional- and non-regional lymph node metastases was 4% and 0.8%, respectively, and the rate of bone metastases was 0.8%. Metastases occurred exclusively in the lumbar column in 0.5% of all patients, in the pelvis in 4%, and the pelvis and lumbar column in 3%. All patients with bone metastases had radT3-4, and patients with radT3-4 showed a four-fold increased risk of lymph node metastases (OR 4.48, 95% CI: 2.1-9.5). CONCLUSION: Bone metastases were found in 10% with high-risk prostate cancer and 0.8% with unfavorable intermediate-risk. Therefore, we question the recommendation to screen the unfavorable intermediate-risk group for bone metastases. KEY POINTS: • The rate of bone metastases was 10% in high-risk patients and 0.8% in the unfavorable intermediate-risk group. • The rate of lymph-node metastases was 17% in high-risk patients and 5% in the unfavorable intermediate-risk group. • No bone metastases were seen in radiologically localized disease.

Antibiotic prophylaxis versus no antibiotic prophylaxis in transperineal prostate biopsies (NORAPP): a randomised, open-label, non-inferiority trial.

BACKGROUND: The benefit of antibiotic prophylaxis is uncertain when performing transperineal prostate biopsies. Judicious use of antibiotics is required as antimicrobial resistance increases worldwide. We aimed to assess whether antibiotic prophylaxis can be omitted when performing transperineal prostate biopsies under local anaesthesia as an outpatient procedure. METHODS: In this randomised, open-label, non-inferiority trial, we aimed to enrol all patients with a suspicion of prostate cancer undergoing transperineal prostate biopsies at two hospitals in Norway and Germany. Patients with a high risk of infection or ongoing infection were excluded. Patients were randomised (1:1) to receive intramuscular (in Norway) or intravenous (in Germany) 1·5 g cefuroxime antibiotic prophylaxis or not. Follow-up assessments were done after 2 weeks and 2 months. The primary outcome was rate of sepsis or urinary tract infections requiring hospitalisation within 2 months. The secondary outcome was the rate of urinary tract infections not requiring hospitalisation. These outcomes were assessed in all eligible randomly allocated participants with a prespecified non-inferiority margin of 4%. Biopsies were performed using an MRI-transrectal ultrasound fusion transperineal technique under local anaesthesia. Patients with a positive MRI underwent 2-4 biopsies per target; in addition, 8-12 systematic biopsies were performed in biopsy naive and MRI-negative patients. This study is registered with ClinicalTrials.gov, NCT04146142. FINDINGS: Between Nov 11, 2019, and Feb 23, 2021, 792 patients were referred for biopsy, of whom 555 (70%) were randomly allocated to treatment groups. 277 (50%) patients received antibiotic prophylaxis and 276 (50%) did not; two (<1%) patients were excluded after randomisation because of unknown allergy to study drug. Sepsis or urinary tract infections requiring hospitalisation occurred in no patients given antibiotic prophylaxis (0%, 95% CI 0 to 1·37) or not given antibiotic prophylaxis (0%, 0 to 1·37; difference 0% [95% CI -1·37 to 1·37]). Urinary tract infections not requiring hospitalisation occurred in one patient given antibiotic prophylaxis (0·36%, 95% CI 0·01 to 2·00) and three patients not given antibiotic prophylaxis (1·09%, 0·37 to 3·15; difference 0·73% [95% CI -1·08 to 2·81]). The number needed to treat with antibiotic prophylaxis to avoid one infection was 137. INTERPRETATION: The non-inferiority margin of 4% was not exceeded, suggesting rates of infections were not higher in patients not receiving antibiotic prophylaxis before transperineal prostate biopsy than in those receiving it. Therefore, antibiotic prophylaxis might be omitted in this population. FUNDING: Oslo University Hospital, Oslo, Norway and Vivantes Klinikum Am Urban, Berlin, Germany.

Predictive Performance of Prospectively Applied ISUP and Fuhrman Grade in Nonmetastatic Renal Cell Carcinoma.

BACKGROUND/AIM: In 2012, the International Society of Urological Pathology (ISUP) recommended replacing Fuhrman with ISUP for grading renal cell carcinoma (RCC). Our aim was to report recurrence-free survival (RFS) and assess prognostic value of ISUP and Fuhrman for predicting recurrence using original pathology assessment and routine follow-up data. PATIENTS AND METHODS: In this single-institution retrospective cohort study, 686 patients underwent a single session total or partial nephrectomy due to nonmetastatic RCC (nmRCC). Of those, 564 had tumors prospectively graded according to either ISUP or Fuhrman, which defined the cohorts. RFS was defined as the interval from surgery to local recurrence and/or metastasis. Differences in RFS were calculated with log rank test. Cox models adjusted for risk factors were used for predicting recurrence. RESULTS: During a median follow-up of 36 months in the ISUP group (n=152), 11% developed recurrent disease. RFS was significantly lower for grade 4 compared to 1-3 (p<0.001), but non-significant between 1-3. Grade was the only significant predictor in multivariate analyses. During a median follow-up time of 50 months in the Fuhrman group (n=412), 16% developed recurrent disease. There was a significant difference in RFS between grades 2 and 3 (p=0.003) and between 3 and 4 (p<0.001), but non-significant between 1 and 2 (p=0.063). Grade, positive surgical margin, tumor size ≥4 cm, and pT were significant predictors of recurrence in multivariate analyses. CONCLUSION: ISUP grading alone is an accurate tool for predicting recurrence in patients with nmRCC.

Cancer Detection Rates in Targeted Transperineal MRI-TRUS Elastic Fusion-guided Prostate Biopsies Performed Under Local Anesthesia.

BACKGROUND/AIM: The aim of this study was to evaluate the cancer detection rate (CDR) using magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion-guided transperineal targeted biopsy (TB). PATIENTS AND METHODS: We included 401 consecutive patients, of which 161 were biopsy-naïve. All underwent prebiopsy bi-parametric MRI; patients with positive MRI [prostate imaging reporting and data system (PI-RADS≥3)] underwent TB. Biopsy-naïve patients with positive MRI underwent TB and systematic biopsies (SBs). MRI-negative patients underwent SBs. Clinically significant prostate cancer (csPCa) was defined as ISUP ≥2. The added value of SB was defined as an upgrade from a negative biopsy or ISUP of 1 in TB to csPCa in SB. RESULTS: The median (interquartile range) age was 69 (range=63-74) years, and PSA was 6.9 (range=4.5-11) ng/ml. The overall CDR was 65%, with csPCa occurring in 48%. In cases of PI-RADS 5, CDR was 91%, and csPCa was 77%. The added value of SB was 2%. CONCLUSION: Transperineal TB biopsies using MRI-TRUS fusion yield a high CDR.

Multicenter transperineal MRI-TRUS fusion guided outpatient clinic prostate biopsies under local anesthesia.

INTRODUCTION: Transperineal Prostate biopsies (TPBx) are usually performed under general anesthesia without image fusion. This study aimed to evaluate prostate cancer (Pca) detection rates (CDR), pain, and adverse events using a novel, free-hand TPBx technique, based on elastic fusion of magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) under local anesthesia. MATERIALS AND METHODS: This multicenter retrospective study included all consecutive patients scheduled for a TPBx. All had clinical suspicion of Pca, active surveillance scheduled for a re-biopsy, or suspicion of local recurrence after previous treatment. Bi-parametric or multiparametric MRI was performed in all patients and classified as positive in the case of Prostate Imaging-Reporting and Data System (PIRADS) suspicion ≥3. At least 1 targeted TPBx was realized from each PIRADS ≥3 index lesion. Six to 12 systematic random TPBx were done in patients with negative MRI. All biopsies were performed under local anesthesia in an outpatient clinic with MRI-TRUS fusion and the 3D navigation system Trinity Perine (Koelis, France). Any- and clinically significant Pca (csPca) (ISUP gr. ≥2) was recorded. Biopsy-related pain and adverse events were reported according to a visual analogue score of 0-10. RESULTS: In total, 377 patients were included for analyses. The mean age was 67 years (95% Confidence Interval: 66-68) and the median prostate-specific antigen was 7.2 ng/ml (interquartile range [IQR] 4.8-11.0). MRI was negative in 6% and positive in 94%. The median MRI prostate volume was 43 ml (IQR 31-60) and the median MRI index tumor volume was 0.9 ml (IQR 0.5-2.1). The median number of TPBx was 4 (IQR 3-4). The overall detection of any- and csPca was 64% and 52%, respectively. The overall CDR according to PIRADS 3, 4, and 5 was 30%, 70%, and 94%, respectively. In patients with negative MRI, any- and csPca was detected in 23% and 9%, respectively. The median visual analogue score score was 2 (IQR 1-3, range 0-7). Two patients (0.5%) developed postbiopsy infection, of which one developed urosepsis. Treatment requiring haematuria or urinary retention did not occur. CONCLUSION: Free-hand MRI/TRUS fusion-guided and systematic random TPBx in LA is a feasible, safe, and well-tolerated technique for diagnosing Pca.

The prevalence and locations of bone metastases using whole-body MRI in treatment-naïve intermediate- and high-risk prostate cancer.

OBJECTIVE: The aim of this study was to assess the prevalence and distribution of bone metastases in treatment-naïve prostate cancer patients eligible for a metastatic workup using whole-body MRI, and to evaluate the results in light of current guidelines. METHODS: This single-institution, retrospective study included all patients with treatment-naïve prostate cancer referred to whole-body MRI during 2016 and 2017. All were eligible for a metastatic workup according to the guidelines: PSA > 20 ng/ml and/or Gleason grade group ≥ 3 and/or cT ≥ 2c and/or bone symptoms. The definition of a metastasis was descriptive and based on the original MRI reports. The anatomical location of metastases was registered. RESULTS: We included 161 patients with newly diagnosed prostate cancer of which 36 (22%) were intermediate-risk and 125 (78%) were high-risk. The median age and PSA were 71 years (IQR 64-76) and 13 ng/ml (IQR 8-28), respectively. Bone metastases were found in 12 patients (7%, 95% CI: 4-13), and all were high-risk with Gleason grade group ≥ 4. The pelvis was affected in 4 patients, and the spine + pelvis in the remaining 8. No patients demonstrated metastases to the spine without concomitant metastases in the pelvis. Limitations are the small number of metastases and retrospective design. CONCLUSION: This study suggests that the overall prevalence of bone metastases using the current guidelines for screening is quite low. No metastases were seen in the case of Gleason grade group ≤ 3, and further studies should investigate if it necessary to screen non-high-risk patients. KEY POINTS: • The overall prevalence of bone metastases was 7% in the case of newly diagnosed intermediate- and high-risk prostate cancer. • The prevalence in high-risk patients was 10%, and no metastases were seen in patients with Gleason grade group ≤ 3. • The pelvic skeleton is the main site, and no metastases occurred in the spine without concomitant pelvic metastases.

Examining the upper urinary tract in patients with hematuria-time to revise the CT urography protocol?

BACKGROUND: Three-phase CT urography (CTU) is the gold standard for evaluating the upper urinary tract in patients with hematuria. We aimed to evaluate the accuracy of CTU for detecting upper urothelial cell carcinomas (UCC) in patients with hematuria and negative cystoscopy. Secondly, we aimed to determine the tumor visibility on each CTU phase. MATERIAL AND METHODS: This retrospective study included all patients with hematuria referred to CTU after a negative cystoscopy during 2016 and 2017. The original CTU reports were dichotomized as negative or positive. All patient charts were reviewed after a minimum of 18-month follow-up in order to register missed cancers. The results of biopsies and clinical follow-up were used as the reference standard. Two reviewers retrospectively evaluated the tumor visibility of each CT sequence in all true-positive CTUs. RESULTS: We included 376 patients with hematuria who underwent CTU after a negative cystoscopy. Macroscopic and microscopic hematuria occurred in 87% (327) and 13% (49), respectively. The incidence of upper urothelial cell carcinoma was 1.9% (7), and the sensitivity of CTU was 100% (95% CI, 59-100), specificity was 99% (95% CI, 98-100), positive predictive value was 88% (95% CI, 47-99), and negative predictive value was 100% (95% CI, 99-100). The accuracy was 99% (95% CI, 90-100). All UCCs were visible on the nephrographic phase for both reviewers. CONCLUSION: CTU is highly accurate for detecting upper UCCs. All cases were seen on the nephrographic phase. This suggests that the CTU protocol can be simplified. KEY POINTS: • CT urography is highly accurate for detecting upper urothelial cell carcinomas. • All cancers were seen on the nephrographic phase. • All cancers were detected in patients with macroscopic hematuria.

MRI in the Follow-up of Testicular Cancer: Less is More.

BACKGROUND/AIM: This study aimed to report the location of abdominal relapse in patients with testicular cancer. MATERIALS AND METHODS: This is a retrospective cross-sectional study including patients who underwent abdominal magnetic resonance imaging (MRI) after treatment of testicular germ cell cancer. MRI reports were classified as negative or positive, and positive results were cross-checked with follow-up imaging and biopsy results. Positive histology or cytology defined a true-positive finding. The location of relapse was registered according to the anatomical site. RESULTS: In a 2-year period, 2,315 MRI examinations were performed. Relapse was detected in 0.7% (95% CI=0.4-1.1) of the examinations. Among these, 75% were seminomas and 25% were non-seminomas. Retroperitoneal lymph nodes were affected in 88% of cases, and pelvic and inguinal lymph nodes affected in 12% of cases. No metastases were found in parenchymatous organs or bony structures. CONCLUSION: All cases of abdominal relapse occurred in retroperitoneal or pelvic lymph nodes. This suggests that MRI should be directed towards the retroperitoneum and pelvis only.

Early experiences with PD-1 inhibitor treatment of platinum resistant epithelial ovarian cancer.

OBJECTIVE: In this study, we evaluated the toxicity and clinical efficacy of nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, on patients with platinum resistant ovarian cancer. METHODS: Every second week, 18 patients with platinum resistance ovarian cancer received nivolumab until disease progression occurred. We assessed toxicity, disease control rate, progression free survival (PFS) and overall survival (OS). Radiological response evaluation according to irRECIST was performed every 12th week, while clinical evaluation was done every second week. RESULTS: The disease control rate was 44% (95% confidence interval [CI]=19-87) as 8 showed stable disease, 6 showed progressive disease and 4 died before the first radiological response evaluation. The median OS was 30 weeks (95% CI=14-42; range, 3-95), and PFS was 15 weeks (95% CI=13-17). The median follow-up time was 30 weeks (range, 3-123). The rate of grade 2-5 adverse events was 28% (5 out of 18). Two patients (11%) developed grade 2 and 3 adverse events, respectively, while no grade 4 events were observed. One patient died from intestinal perforation, believed to be caused by concomitant bevacizumab rather than nivolumab. CONCLUSION: This study shows few adverse events, and promising clinical efficacy when using nivolumab for ovarian cancer.

A prospective study evaluating indirect MRI-signs for the prediction of extraprostatic disease in patients with prostate cancer: tumor volume, tumor contact length and tumor apparent diffusion coefficient.

OBJECTIVE: The aim of this study was to evaluate three indirect MRI signs for predicting extraprostatic disease in patients referred to radical prostatectomy: index tumor volume (MTV), apparent diffusion coefficient (ADC) and tumor contact length (TCL). MATERIALS AND METHODS: This prospective study included 183 patients with biopsy proven prostate cancer. In all patients the MTV (ml), ADC (× 10-5 mm2/s) and TCL (mm) of the index tumor were registered at the preoperative MRI. Whole-mounted microscopical examination classified each patient as having either localized- or extraprostatic disease. The Youden index was used to identify the optimal cut-off values for predicting extraprostatic disease. Univariate regression analyses were conducted to estimate the odds ratio (OR) with 95% confidence intervals (CI). Results were stratified upon zonal location of the index tumor. RESULTS: Extraprostatic disease was identified in 103 (56%) patients. The risk of extraprostatic disease was nine times higher in peripheral zone tumors with ADC ≤ 89 (OR 9.1, 95% CI 4.2-19.6), five times higher in MTV ≥ 0.9 ml (OR 5.5, 95% CI 2.6-11.4) and five times higher in case of TCL ≥ 14 mm (OR 4.9, 95% CI 2.3-10.2). None of the indirect MRI signs could predict extraprostatic disease for transition zone tumors. CONCLUSION: The MTV, ADC and TCL are all significant predictors of extraprostatic disease for peripheral zone tumors, while none of the indirect signs were useful for transition zone tumors.

A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy.

BACKGROUND: Prostate biopsy guided by computer-assisted fusion of magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) images (MRI group) has not yet been compared with 12-core random biopsy (RB; control group) in a randomized controlled trial (RCT). OBJECTIVE: To compare the rate of detection of clinically significant prostate cancer (csPCa) between the two groups. DESIGN, SETTING, AND PARTICIPANTS: This RCT included 175 biopsy-naïve patients with suspicion for prostate cancer, randomized to an MRI group (n=86) and a control group (n=89) between September 2011 and June 2013. INTERVENTION: In the MRI group, two-core targeted biopsy (TB) guided by computer-assisted fusion of MRI/TRUS images of MRI-suspicious lesions was followed by 12-core RB. In the control group, both two-core TB for abnormal digital rectal examination (DRE) and/or TRUS-suspicious lesions and 12-core RB were performed. In patients with normal MRI or DRE/TRUS, only 12-core RB was performed. OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: The detection rates for any cancer and csPCa were compared between the two groups and between TB and RB. RESULTS AND LIMITATIONS: Detection rates for any cancer (MRI group 51/86, 59%; control group 48/89, 54%; p=0.4) and csPCa (38/86, 44% vs 44/89, 49%; p=0.5) did not significantly differ between the groups. Detection of csPCa was comparable between two-core MRI/TRUS-TB (33/86, 38%) and 12-core RB in the control group (44/89, 49%; p=0.2). In a subset analysis of patients with normal DRE, csPCa detection was similar between two-core MRI/TRUS-TB (14/66, 21%) and 12-core RB in the control group (15/60, 25%; p=0.7). Among biopsy-proven csPCas in MRI group, 87% (33/38) were detected by MRI/TRUS-TB. The definition of csPCa was only based on biopsy outcomes. CONCLUSION: Overall csPCa detection was similar between the MRI and control groups. Two-core MRI/TRUS-TB was comparable to 12-core RB for csPCa detection. PATIENT SUMMARY: Our randomized controlled trial revealed a similar rate of prostate cancer detection between targeted biopsy guided by magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) and 12-core random biopsy. The traditional 12-core random biopsy may be replaced by two-core MRI/TRUS targeted biopsy for detection of clinically significant prostate cancer.