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.

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.

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.