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

Jacewicz, Maciej; Günzel, Karsten; Rud, Erik; Sandbæk, Gunnar; Magheli, Ahmed; Busch, Jonas; Hinz, Stefan; Baco, Eduard

doi:10.1016/s1473-3099(22)00373-5

Cited by 72 publications

(41 citation statements)

References 25 publications

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“…Notably, there were no reported cases of sepsis or prostatitis despite the lack of prophylactic antibiotics. The results from the sample used here corroborate the findings and complication rate of the NORAPP trial, which did not find a benefit of prophylactic antibiotics in transperineal biopsy 6 .…”

Section: Discussionsupporting

confidence: 83%

Micro-Ultrasound Guided Transperineal Prostate Biopsy: A Clinic-Based Procedure

Ashouri

Nguyen

Archer

et al. 2023

JoVE

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Prostate cancer is the most common solid malignancy in men and requires a biopsy for diagnosis. This manuscript describes a freehand micro-ultrasound guided transperineal technique performed under local anesthesia, which maintains accuracy, keeps patients comfortable, has low adverse events, and minimizes the need for disposables. Prior micro-ultrasound-guided transperineal techniques required general or spinal anesthesia. The key steps described in the protocol include (1) the placement of the local anesthesia, (2) micro-ultrasound imaging, (3) and the visualization of the anesthetic/biopsy needle while uncoupled from the insonation plane. A retrospective review of 100 patients undergoing this technique demonstrated a 68% clinically significant cancer detection rate. Pain scores were prospectively collected in a subset of patients (N = 20) and showed a median procedural pain score of 2 out of 10. The 30 day Grade III adverse event rate was 3%; one of these events was probably related to the prostate biopsy. Overall, we present a simple, accurate, and safe technique for performing a micro-ultrasound-guided transperineal prostate biopsy.

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Section: Discussionsupporting

confidence: 83%

Micro-Ultrasound Guided Transperineal Prostate Biopsy: A Clinic-Based Procedure

Ashouri

Nguyen

Archer

et al. 2023

JoVE

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“…Multiple studies have demonstrated the transperineal approach, compared with the transrectal approach, contributes to reduced infectious complications 24–26. While infectious complications after transperineal biopsy are possible, rates of infection are low even without the use of prophylactic antibiotics 27–29. Therefore, the transperineal prostate biopsy can be performed without prophylactic antibiotics and is recommended by multiple guidelines 20 30 31.…”

Section: Introductionmentioning

confidence: 99%

Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications

Zhu

Allaf³

et al. 2023

BMJ Open

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IntroductionApproximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer.Methods and analysisWe will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer.Ethics and disseminationThe Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals.Trial registration numberNCT04815876.

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“…Transrectal ultrasound-guided transperineal prostate biopsy (TPPBx) has largely replaced transrectal prostate biopsy (TRUS +Bx) as the procedure of choice by patients with high prostatespecific antigen (PSA) due to the high infection rates of TRUS +Bx. In addition, the overall infection rate after TPPBx was approximately 1% (Chiu et al, 2021;Gunzel et al, 2021;Castellani et al, 2022;Jacewicz et al, 2022). However, the use of prophylactic antibiotics is still in place.…”

Section: Introductionmentioning

confidence: 99%

Oral antibiotics perturbation on gut microbiota after prostate biopsy

Wang

Lau

et al. 2022

Front. Cell. Infect. Microbiol.

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IntroductionThe use of antibiotics may induce the changes in gut microbiota. Previous studies have shown conflicting results on whether the changed gut microbiota by antibiotics can be recovered. Our study aims to investigate whether the gut microbiota could be recovered after a single dose of oral co-amoxiclav before transrectal ultrasound-guided transperineal prostate biopsy (TPPBx) in 5 weeks’ time.MethodsFifteen patients with elevated serum prostate-specific antigen (PSA) were recruited to provide pre-antibiotic and post-antibiotic fecal samples. The V4 region of 16S rRNA was sequenced. Analysis was performed by QIIME2. Alpha- and beta-diversities were analyzed, as well as the differential enrichment by Linear discriminant analysis Effect Size (LEfSe) analysis.ResultsBoth the alpha- and beta-diversities of the pre- and post-antibiotic fecal samples were significantly different. Genera that are associated with alleviation of inflammation were enriched in the pre-antibiotic fecal samples, while the inflammation-associated genera were more enriched in the post-antibiotic fecal samples.ConclusionA single dose of oral co-amoxiclav before TPPBx could have led to a change of gut microbiota that cannot be recovered in 5 weeks' time. Microbiome studies on prostate cancer patients should be cautioned on the use of post-prostate biopsy fecal sampling. Further studies should be conducted for the impact on gut microbiome for TPPBx alone.

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

Cited by 72 publications

References 25 publications

Micro-Ultrasound Guided Transperineal Prostate Biopsy: A Clinic-Based Procedure

Micro-Ultrasound Guided Transperineal Prostate Biopsy: A Clinic-Based Procedure

Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications

Oral antibiotics perturbation on gut microbiota after prostate biopsy

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