Transperineal freehand multiparametric MRI fusion targeted biopsies under local anaesthesia for prostate cancer diagnosis: a multicentre prospective study of 1014 cases.

OBJECTIVE: To assess the outcomes of multiparametric magnetic resonance imaging (mpMRI) transperineal targeted fusion biopsy (TPFBx) under local anaesthesia. PATIENTS AND METHODS: We prospectively screened 1327 patients with a positive mpMRI undergoing TPFBx (targeted cores and systematic cores) under local anaesthesia, at two tertiary referral institutions, between September 2016 and May 2019, for inclusion in the present study. Primary outcomes were detection of clinically significant prostate cancer (csPCa) defined as (1) International Society of Urological Pathologists (ISUP) grade >1 or ISUP grade 1 with >50% involvement of prostate cancer (PCa) in a single core or in >2 cores (D1) and (2) ISUP grade >1 PCa (D2). Secondary outcomes were: assessment of peri-procedural pain (numerical rating scale [NRS]) and procedure timings; erectile (International Index of Erectile Function) and urinary (International Prostate Symptom Score) function changes; and complications. We also investigated the value of systematic sampling and concordance with radical prostatectomy (RP). RESULTS: A total of 1014 patients were included, of whom csPCa was diagnosed in 39.4% (n = 400). The procedure was tolerable (NRS pain score 3.1 ± 2.3), with no impact on erectile (P = 0.45) or urinary (P = 0.58) function, and a low rate of complications (Clavien-Dindo grades 1 or 2, n = 8; grade >2, n = 0). No post-biopsy sepsis was recorded. Twenty-two men (95% confidence interval [CI] 17-29) needed to undergo additional systematic biopsy to diagnose one csPCa missed by targeted biopsies (D1). ISUP grade concordance of biopsies with RP was as follows: k = 0.40 (95% CI 0.31-0.49) for targeted cores alone and k = 0.65 (95% CI 0.57-0.72; P < 0.05) overall. CONCLUSIONS: The use of TPFBx under local anaesthesia yielded good csPCa detection and was feasible, quick, well tolerated and safe. Infectious risk was negligible. Addition of systematic to targeted cores may not be needed in all men, although it improves csPCa detection and concordance with RP.

Pain in Men Undergoing Transperineal Free-Hand Multiparametric Magnetic Resonance Imaging Fusion Targeted Biopsies under Local Anesthesia: Outcomes and Predictors from a Multicenter Study of 1,008 Patients.

PURPOSE: Several transperineal biopsy series have proven feasibility under local anesthesia. However, there is a lack of large analyses detailing pain outcomes and factors influencing pain. MATERIALS AND METHODS: From 2016 to 2019 we performed a multicenter prospective study in men undergoing multiparametric magnetic resonance imaging-transperineal fusion biopsies (target+systematic cores) under local anesthesia. Primary outcomes were 1) pain scores (assessed through a 0 to 10-point numeric rating scale) and 2) identification of factors associated with severe pain. The secondary outcome was to evaluate pain influence on clinically significant prostate cancer target cores detection. RESULTS: We included 1,008 men undergoing transperineal fusion biopsies under local anesthesia. Mean±SD numeric rating scale pain scores were 3.9±2.1 at local anesthesia administration and 3.1±2.3 when performing biopsies. Pain was not associated with lower clinically significant prostate cancer detection on targeted cores (p=0.23 and p=0.47 depending on clinically significant prostate cancer definition). On multivariate analysis age (OR 0.96, 95% CI 0.94-0.99) and severe anxiety (OR 2.99, 95% CI 1.83-4.89) were a protective and risk factor, respectively, for severe biopsy pain. Procedural time was also associated with an increased risk of experiencing severe biopsy pain (OR 1.04, 95% CI 1.00-1.08). If aiming to test the possible effects of anxiety preventive measures on pain, an anxiety cutoff greater than 6 on a numeric rating scale would decrease to 13% the number of patients being treated while identifying 56% of those experiencing severe pain. CONCLUSIONS: Transperineal fusion biopsies under local anesthesia result in moderate pain. Pain does not influence clinically significant prostate cancer target detection. Patient anxiety predicts pain. A numeric rating scale based anxiety assessment may be used to identify those at higher risk for experiencing severe pain in men undergoing transperineal fusion biopsies.

Periprostatic nerve block alone versus combined with perineal pudendal nerve block or intrarectal local anesthesia during transrectal ultrasound-guided prostate biopsy: A prospective randomized controlled trial.

OBJECTIVES: To compare the efficacy, safety and cost of combinations of perineal pudendal nerve block + periprostatic nerve block and intrarectal local anesthesia + periprostatic nerve block with the standard technique (periprostatic nerve block). METHODS: The study was designed as a randomized prospective controlled trial. Patients with elevated serum prostate-specific antigen values (prostate-specific antigen ≥4 ng/mL) and/or abnormal digital rectal examination findings were included in the study. Patients with anorectal diseases, chronic prostatitis, previous history of prostate biopsy and anorectal surgery were excluded from the study. A total of 148 patients (group 1 [periprostatic nerve block], n = 48; group 2 [intrarectal local anesthesia + periprostatic nerve block], n = 51; group 3 [perineal pudendal nerve block + periprostatic nerve block], n = 49) were included in the final analysis. Pain during insertion and manipulation of the transrectal ultrasound probe was recorded as visual analog scale 1, pain during penetration of the biopsy needle into the prostate and sampling was recorded as visual analog scale 2, and pain during the entire procedure recorded as visual analog scale 3. RESULTS: The mean visual analog scale 1 score was significantly lower in group 3, when compared with group 1 and group 2 (P < 0.001). There was no significant difference between the groups in terms of the mean visual analog scale 2 score. The mean visual analog scale 3 score was significantly lower in group 3 when compared with other groups (P < 0.001). The total cost for transrectal ultrasound-guided biopsy in the intrarectal local anesthesia + periprostatic nerve block group was significantly higher than the other two groups. CONCLUSIONS: The combination of perineal pudendal nerve block and periprostatic nerve block provides more effective pain control than intrarectal local anesthesia plus periprostatic nerve block and periprostatic nerve block alone, with similar complication rates and without increasing cost.

The effect of intraparenchymal blood patching on the rate of pneumothorax in patients undergoing percutaneous CT-guided core biopsy of the lung.

PURPOSE: To assess the effect of intraparenchymal blood patching (IBP) as well as tumor- and operator-related risk factors on the rate of pneumothoraxes after percutaneous CT-guided core needle biopsy of the lung. MATERIALS AND METHODS: We performed a retrospective analysis of 868 CT-guided lung biopsies that were conducted at our institution between 2003 and 2018, of which 419 (48%) received an IBP. Outcome variable included the rates of pneumothorax and chest tube placement, as well as lesion size (<3 cm versus ≥3 cm long axis diameter), lesion depth (≤2 cm, >2-4 cm, >4-5 cm and >5 cm distance to the pleura), location within the lungs (upper lobe, lower lobe, middle lobe), needle caliber (13 G, 15 G, 17 G, 19 G), number of samples taken (1-3 versus ≥4 samples), and experience of the performing physician. RESULTS: The rate of pneumothorax was significantly (p < 0.05) lower in the group with IBP (10.7%) compared to the group without IBP (15.4%). The number of post-interventional chest tube placements was also lower in the IBP group (3.1% vs. 5.8%) but not statistically significant. The lesion size correlated negatively with the rate of pneumothoraxes, whereas in both groups (±IBP) lesions ≥ 3 cm showed a significantly lower rate of pneumothorax (p < 0.05). With increasing lesion depth, the pneumothorax rate increased with (p < 0.01) and without (p < 0.001) IBP. The rate of pneumothorax was significantly lower (p < 0.05) for 17 G needles with IBP, but not for other calibers. For biopsies in the lower lobe, the pneumothorax rate reduced significantly (p < 0.001) with IBP. In case of ≥4 tissue samples, the pneumothorax rate was significantly lower with IBP (p < 0.01). For experienced operators, the overall pneumothorax rate was significantly lower compared to less experienced operators (p < 0001). CONCLUSIONS: IBP significantly reduces the rate of pneumothorax following CT-guided lung biopsies in particular for lesions located deeper in the lungs, when ≥4 samples are taken, when samples are taken by less-experienced operators, and when sampling from the lower lobes.

Use of fosfomycin as targeted antibiotic prophylaxis before prostate biopsy: A prospective randomized study.

OBJECTIVES: To investigate whether switching ciprofloxacin to fosfomycin in the case of fluoroquinolone-resistant rectal bacteria influences the incidence of infectious complications after transrectal prostate biopsy. METHODS: From December 2015 until December 2017, patients undergoing prostate biopsy were randomly assigned to a control group or an intervention group in a prospective, open-label fashion at three different centers. The presence of fluoroquinolone-resistant organisms was detected by rectal swabs. Patients in the control group received ciprofloxacin. Patients in the intervention group received fosfomycin instead of ciprofloxacin in the case of fluoroquinolone-resistant bacteria on rectal swab culture. The primary end-point was the difference in occurrence of major (febrile) and minor (afebrile) infections between both groups. RESULTS: A total of 102 patients were randomized to the control group, and 102 patients to the intervention group. In the control group, nine complications occurred, of which five were major febrile complications. In the intervention group, six complications occurred, of which four were major febrile complications. The total number of complications (major and minor) did not differ between both groups (P = 0.59). A subgroup analysis of patients with fluoroquinolone-resistant bacteria on rectal swab showed five complications in the control group and one complication in the intervention group (P = 0.09). CONCLUSIONS: This represents the first prospective randomized study using rectal cultures for targeted antibiotic prophylaxis. Study findings show promising results for use of fosfomycin in patients with fluoroquinolone resistance.

Active surveillance for localized prostate cancer: an analysis of patient contacts and utilization of healthcare resources.

OBJECTIVE: Evidence supports active surveillance (AS) as a means to reduce overtreatment of low-risk prostate cancer (PCa). The consequences of close and long-standing follow-up with regard to outpatient visits, tests and repeated biopsies are widely unknown. This study investigated the trajectory and costs of AS in patients with localized PCa. MATERIALS AND METHODS: In total, 317 PCa patients were followed in a prospective, single-arm AS cohort. The primary outcomes were number of patient contacts, prostate-specific antigen (PSA) tests, biopsies, hospital admissions due to biopsy complications and patients eventually undergoing curative treatment. The secondary outcome was cost. RESULTS: The 5 year cumulative incidence of discontinued AS in a competing-risk model was 40%. During the first 5 years of AS patients underwent a median of two biopsy sets, and patients were seen in an outpatient clinic including PSA testing three to four times annually. In total, 38 of the 406 biopsy sessions led to hospital admission and 87 of the 317 patients required treatment for bladder outlet obstruction (BOO). With a median of 3.7 years' follow-up, the total cost of AS was euro (€) 1,240,286. Assuming all patients had otherwise undergone primary radical prostatectomy, the cost difference favoured AS with a net benefit of €662,661 (35% reduction). CONCLUSIONS: AS entails a close clinical follow-up with a considerable risk of rebiopsy complication, treatment of BOO and subsequent delayed definitive therapy. This risk should be weighed against a potential economic benefit and reduction in the risk of overtreatment compared to immediate radical treatment.

A relaxation response training for women undergoing breast biopsy: exploring integrated care.

BACKGROUND: Recent changes in clinical guideline recommendations for age of breast cancer screening initiation highlighted the potential psychological ramifications associated with screening. This study examined the feasibility, acceptability, and preliminary efficacy of a brief Relaxation Response training (RRT) to decrease distress among women undergoing breast biopsy. METHODS: Women scheduled for percutaneous core-needle biopsy were recruited into a single-arm RRT trial, including 3 individual sessions. Psychosocial assessments were completed pre- and postintervention. RESULTS: Forty women were enrolled between 6/1/10 and 8/31/11. Among enrollees, 75% completed all 3 RRT sessions, and 75% completed the post-assessment. Participants showed significant reductions in acute distress following each RRT session. Qualitative feedback indicated a positive impact of RRT on clinic care experiences. CONCLUSIONS: RRT is a portable intervention that was feasible to implement, acceptable to patients and associated with significant decreases in acute emotional distress during the period of diagnostic uncertainty related to percutaneous breast biopsy.