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

doi:10.1016/j.urolonc.2020.11.009

Urologic Oncology: Seminars and Original Investigations

Volume 39, Issue 7, July 2021, Pages 432.e1-432.e7

https://doi.org/10.1016/j.urolonc.2020.11.009 Get rights and content

Highlights

•
Transperineal MRI-ultrasound fusion guided prostate biopsies in local anesthesia are accurate, feasible and well tolerated in an outpatient setting.
•
The median VAS score for the procedure was 2, no procedures were aborted due to pain.
•
The rate of post biopsy infections was 0.5%.
•
In case of PIRADS 5 tumors, the cancer detection rate was 94%.

Abstract

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.

Introduction

Prostate biopsies (PBx) are needed for confirming the diagnosis of prostate cancer (Pca) and are usually performed by either a transrectal or transperineal approach. The main benefit of transperineal prostate biopsy (TPBx) is an approximately 7 times lower risk of infections as compared to the transrectal method [1]. However, the advantage has been hampered by the need for general or spinal anesthesia in the operating theater, while transrectal biopsies are performed under local anesthesia (LA) in the outpatient clinic. After the introduction of prebiopsy magnetic resonance imaging (MRI), the demand for accurate targeted biopsies has gained general acceptance. Several commercial navigation systems are available, but these have been available mainly for a transrectal approach. Lately, transperineal navigation systems have also become available, allowing for accurate targeted biopsies rather than the typical template-based procedures under spinal or general anesthesia.

At our institutions, we routinely perform MRI prior to all biopsies, and we have implemented transperineal MRI-ultrasound fusion guided targeted biopsies under LA as standard biopsy practice. This allows for equally accurate biopsies in the outpatient clinic, with minimal risk of infections [2–5].

This multicenter study aims to report the feasibility, cancer detection rates (CDR), pain, and adverse events using a free-hand TPBx technique, based on elastic fusion of MRI and transrectal ultrasound (TRUS) under LA.

Section snippets

Materials and methods

This multicenter retrospective study included all consecutive patients who underwent transperineal PBx performed at Oslo University Hospital, Aker, Norway and at Vivantes Klinikum in Berlin, Germany. The inclusion period in Oslo was from October 1, 2017 to December 31, 2018, while in Berlin it was from October 1, 2019 to January 31, 2020.

Indications for biopsy were elevated prostate-specific antigen (PSA) on 2 or more occasions, and/or an abnormal digital rectal examination. Patients on active

Results

In total, 377 patients were included for analyses: 209 from Oslo and 168 from Berlin. The indications for biopsies were: primary biopsy: 46% (174), re-biopsy after previous negative biopsies: 25% (93), re-biopsy due to active surveillance: 20% (77), routine biopsy after high-intensity focused ultrasound: 6% (22), PSA recurrence after radiation therapy: 3% [10].

The mean age was 67 years (95% CI: 66–68) and the median PSA was 7.2 ng/ml (IQR 4.8–11.0).

MRI was negative in 6% (95% CI: 4–9) and

Discussion

In this study, we investigated a new, free-hand trans-perineal MRI-TRUS fusion guided prostate biopsy using organ-based tracking technology, in LA.

The primary aims were to evaluate the feasibility, diagnostic value, efficacy of LA, postbiopsy infection rate, and adverse events.

Limitations

This study has several limitations.

First, the results of this work were evaluated retrospectively in a heterogeneous study population. However, the various biopsy indications represent daily clinical practice.

Secondly, this is only a 2-center study and must be more extensively validated.

Thirdly, a systematic random prostate biopsy was routinely performed only in patients with negative MRI. Several previous trials have shown that MRI cannot detect all Pcas [13,19]. Therefore, the added benefit

Conclusion

Free-hand MRI-TRUS fusion-guided and systematic random TPBx in LA is a feasible, safe, and well-tolerated technique for diagnosing Pca. Future multicenter studies are warranted for this to become a standard method for Pca diagnosis in an outpatient setting.

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Transperineal prostate biopsies using local anesthesia: experience with 1,287 patients. Prostate cancer detection rate, Complications and patient tolerability
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Free-hand transperineal prostate biopsy provides acceptable cancer detection and minimizes risk of infection: evolving experience with a 10-sector template
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Cited by (18)

Patient Reported Outcomes of Transperineal Prostate Biopsy With Tumescent Local Anesthesia
2023, Urology
To report the outcomes of performing transperineal prostate biopsy in the office setting using the novel anesthetic technique of tumescent local anesthesia. We report anxiety, pain, and embarrassment of patients who underwent this procedure compared to patients who underwent a transrectal prostate biopsy using standard local anesthesia.
Consecutive patients undergoing either a transperineal prostate biopsy under tumescent local anesthesia or a transrectal prostate biopsy with standard local anesthetic technique were prospectively enrolled. The tumescent technique employed dilute lidocaine solution administered using a self-filling syringe. Patients were asked to rate their pain before, during, and after their procedure using a visual analog scale. Patient anxiety and embarrassment was assessed using the Testing Modalities Index Questionnaire.
Between April 2021 and June 2022, 430 patients underwent a transperineal prostate biopsy using tumescent local anesthesia and 65 patients underwent a standard transrectal prostate biopsy. Patients who underwent a transperineal biopsy had acceptable but significantly higher pain scores than those who underwent a transrectal prostate biopsy (3.9 vs 1.6, P-value <.01). These scores fell to almost zero immediately following their procedure. Additionally, transperineal biopsy patients were more likely to experience anxiety (71% vs 45%, P < .01) and embarrassment (32% vs 15%, P < .01).
Transperineal biopsy using local tumescent anesthesia is safe and well-tolerated. Despite the benefits, patients undergoing a transperineal prostate biopsy under tumescent anesthesia still experienced worse procedural pain, anxiety, and embarrassment. Additional studies examining other adjunctive interventions to improve patient experience during transperineal prostate biopsy are needed.
Weakly supervised volumetric prostate registration for MRI-TRUS image driven by signed distance map
2023, Computers in Biology and Medicine
Image registration is a fundamental step for MRI-TRUS fusion targeted biopsy. Due to the inherent representational differences between these two image modalities, though, intensity-based similarity losses for registration tend to result in poor performance. To mitigate this, comparison of organ segmentations, functioning as a weak proxy measure of image similarity, has been proposed. Segmentations, though, are limited in their information encoding capabilities. Signed distance maps (SDMs), on the other hand, encode these segmentations into a higher dimensional space where shape and boundary information are implicitly captured, and which, in addition, yield high gradients even for slight mismatches, thus preventing vanishing gradients during deep-network training. Based on these advantages, this study proposes a weakly-supervised deep learning volumetric registration approach driven by a mixed loss that operates both on segmentations and their corresponding SDMs, and which is not only robust to outliers, but also encourages optimal global alignment. Our experimental results, performed on a public prostate MRI-TRUS biopsy dataset, demonstrate that our method outperforms other weakly-supervised registration approaches with a dice similarity coefficient (DSC), Hausdorff distance (HD) and mean surface distance (MSD) of 87.3 ± 11.3, 4.56 ± 1.95 mm, and 0.053 ± 0.026 mm, respectively. We also show that the proposed method effectively preserves the prostate gland's internal structure.
Vector Prostate Biopsy: A Novel Magnetic Resonance Imaging/Ultrasound Image Fusion Transperineal Biopsy Technique Using Electromagnetic Needle Tracking Under Local Anaesthesia
2023, European Urology
Prostate magnetic resonance imaging (MRI) is now standard for assessment of suspected prostate cancer (PCa). A variety of approaches to MRI-based targeting has revolutionised prostate biopsies.
To describe the procedure and show the accuracy and tolerability of a novel Vector MRI/ultrasound fusion transperineal (TP) biopsy technique that uses electromagnetic (EM) needle tracking under local anaesthesia (LA).
Vector prostate biopsy using BiopSee fusion software, EM tracking technology, and transrectal ultrasound was performed in 69 patients meeting the biopsy criteria in two UK centres between September 2020 and August 2022.
Stepper-mounted rectal ultrasound images were fused with MRI scans. LA was applied into two defined perineal tracks and a needle sheath with an EM sensor was inserted. The biopsy needle was directed precisely through the sheath to MRI targets under EM tracking. Biopsies were taken without antibiotic prophylaxis.
Cancer detection (any PCa; grade group ≥2), side effects, and patient experience measures were recorded.
Cancer detection in patients with Likert 4–5 lesions was 98% for any PCa and 83% for grade group ≥2. According to the 50 questionnaires returned, 42 patients (84%) reported no or minimal pain, while 40 (80%) reported no or minimal discomfort. No episodes of postoperative urinary retention occurred, and only one patient required treatment for infection. Limitations include the low patient number and incomplete responses to questionnaires.
This novel Vector technique provides a feasible and tolerable procedure for MRI/ultrasound fusion TP biopsy under LA, with high cancer detection rates. This is achieved while maintaining patient comfort and with minimal rates of complications.
We report a novel technique that uses electromagnetic needle tracking to perform highly accurate and comfortable prostate biopsies through the perineum under local anaesthetic.
Antibiotic prophylaxis versus no antibiotic prophylaxis in transperineal prostate biopsies (NORAPP): a randomised, open-label, non-inferiority trial
2022, The Lancet Infectious Diseases
Citation Excerpt :
Approximately 20 mL of local anaesthetic was injected below the prostatic apex, bilaterally in the levator ani, and along the needle's path. 10 min was given for the optimal effect of local anaesthesia.14 Biopsies were performed with a freehand technique using a three-dimensional ultrasound probe fixed to a holding arm (Steady Pro; Koelis, France) and an 18-gauge, 19 mm notch length biopsy needle (HistoCore; BIP, Germany).
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.
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.
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.
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.
Oslo University Hospital, Oslo, Norway and Vivantes Klinikum Am Urban, Berlin, Germany.
Fosfomycin Trometamol for the Prevention of Infectious Complications After Prostate Biopsy: A Consensus Statement by an International Multidisciplinary Group
2022, European Urology Focus
Transrectal ultrasound-guided prostate biopsy (TRPB) has been a standard of care for diagnosing prostate cancer but is associated with a high incidence of infectious complications.
To achieve an expert consensus on whether fosfomycin trometamol provides adequate prophylaxis in TRPB and discuss its role as prophylaxis in transperineal prostate biopsy (TPPB).
An international multidisciplinary group of experts convened remotely to discuss how to best use fosfomycin in various clinical settings and patient situations. Six statements related to prostate biopsy and the role of fosfomycin were developed, based on literature searches and relevant clinical experience.
Consensus was reached for all six statements. The group of experts was unanimous regarding fosfomycin as a preferred candidate for antimicrobial prophylaxis in TRPB. Fosfomycin potentially also meets the requirements for empiric prophylaxis in TPPB, although further clinical studies are needed to confirm or refute its utility in this setting. There is a risk of bias due to sponsorship by a pharmaceutical company.
Antimicrobial prophylaxis is mandatory in TRPB, and fosfomycin trometamol is an appropriate candidate due to low rates of resistance, a good safety profile, sufficient prostate concentrations, and demonstrated efficacy in reducing the risk of infectious complications following TRPB.
Patients undergoing transrectal ultrasound-guided prostate biopsy (TRPB) have a high risk of infectious complications, and antimicrobial prophylaxis is mandatory. However, increasing antimicrobial resistance, as well as safety concerns with fluoroquinolones, has restricted the number of antimicrobial options. Fosfomycin trometamol meets the requirements for a preferred antimicrobial in the prophylaxis of TRPB.
Comparisons of efficacy and complications between transrectal and transperineal prostate biopsy with or without antibiotic prophylaxis
2022, Urologic Oncology: Seminars and Original Investigations
Citation Excerpt :
Moreover, Szabo et al. [13] suggested that no sepsis was found among 212 patients after TPBx who had not received antibiotic prophylaxis. Another study of 377 cases of TPBx showed that 39% of patients received prophylactic antibiotics before surgery, and the overall prevalence of post-biopsy infection was only 0.5% [14]. The role of antibiotic prophylaxis in TPBx is uncertain due to the low infection rates using a TPBx technique, even without antibiotic prophylaxis.
We aimed to determine the cancer detection rate and complications of transrectal prostate biopsy (TRBx) and transperineal prostate biopsy (TPBx) in the hospital. However, given the use of antibiotic prophylaxis in TPBx remains controversial according to the current guidelines, we also investigated the safety and side effects of TPBx with and without antibiotic prophylaxis.
A total of 777 patients who underwent prostate biopsy were enrolled in this study in accordance with the criteria. The primary outcome was pooled infectious complications (sepsis, fever, symptomatic urinary tract infection and urinary retention), and the secondary outcome was prostate cancer detection rate.
Findings showed that TPBx and TRBx were equivalent in terms of prostate cancer detection rate (TPBx: 50.4% vs. TRBx: 47.3%; P = 0.424) and urinary retention (TPBx: 5% vs. TRBx: 6.3%; P = 0.451). However, TRBx had significantly higher incidences of sepsis (risk ratios, RR: 3.65, 95% confidence interval [CI]: 1.21–11.03; P = 0.014) and symptomatic urinary tract infection (RR: 3.04, 95% CI: 1.07–8.66; P = 0.029) than TPBx. Notably, for TPBx, patients who received a single dose of cephazolin prophylaxis were not associated with the risk of sepsis (RR: 0.78, 95% CI: 0.13–4.63; P = 0.783) and symptomatic urinary tract infection (RR: 1.17, 95% CI: 0.24–5.74; P = 0.848) in contrast to patients who did not receive any antibiotic prophylaxis. Meanwhile, no effects on prostate cancer detection rate and urinary retention were observed in the TPBx group.
Our findings indicated that TPBx significantly reduced infectious complications compared with TRBx and should therefore be preferred. Importantly, we need to re-examine whether the antibiotic prophylaxis should be routinely applied before TPBx in consideration of increasing antibiotic resistance. This result complements the current national guidelines. Nevertheless, future studies on this topic with improved quality and increased sample size are still needed to minimise bacterial resistance.

View all citing articles on Scopus

: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sector.

^#: These authors participated equally

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Clinical-Prostate cancerMulticenter transperineal MRI-TRUS fusion guided outpatient clinic prostate biopsies under local anesthesia

Highlights

Abstract

Introduction

Materials and methods

Results

Conclusion

Introduction

Section snippets

Materials and methods

Results

Discussion

Limitations

Conclusion

Urol Oncol

Eur Urol

Lancet

Urology

J Urol

Assessment of pain

Br J Anaesth

Comparisons of cancer detection rate and complications between transrectal and transperineal prostate biopsy approaches - a single center preliminary study

BMC Urol

Transperineal prostate biopsies using local anesthesia: experience with 1,287 patients. Prostate cancer detection rate, Complications and patient tolerability

J Urol

Free-hand transperineal prostate biopsy provides acceptable cancer detection and minimizes risk of infection: evolving experience with a 10-sector template

Urol Oncol

Clinical-Prostate cancer
Multicenter transperineal MRI-TRUS fusion guided outpatient clinic prostate biopsies under local anesthesia