Clinical Trial Protocol for PERFECT: A Randomised Controlled Trial Comparing the Efficiency and Tolerance of Transperineal Fusion Versus Transrectal Imaging-targeted Prostate Biopsies (CCAFU-PR1 Study)

Touzani, Alae; Fiard, G.; Barret, Éric; Renard-Penna, Raphaële; Salin, Ambroise; Pradère, Benjamin; Rozet, François; Beauval, Jean-Baptiste; Malavaud, Bernard; Giannarini, Gianluca; Colin, P.; Rouprêt, Morgan; Ploussard, Guillaume

doi:10.1016/j.euros.2022.09.007

Cited by 17 publications

(5 citation statements)

References 21 publications

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“…The TransPERineal Fusion Biopsy Versus transrectal (PERFECT) study (NCT05069584) is a RCT comparing TRUS vs TP biopsy, when performing MRI-targeted fusion biopsies, with a primary outcome of detection of clinically significant prostate cancer [22]. Prostate Imaging-Reporting and Data System (PI-RADS) 4 or 5 lesions are required for targeting, and systematic biopsies are also performed.…”

Section: Current Trialsmentioning

confidence: 99%

Perspectives on technology – prostate cancer: is local anaesthetic transperineal prostate biopsy really better than transrectal biopsy?

Berridge,

Omer,

Lopez

et al. 2024

BJU International

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For many years, transrectal ultrasound‐guided (TRUS) prostate biopsies have been performed to establish a histological diagnosis of prostate cancer. This has been the recommended standard of care procedure, but has always carried risks, in particular the risk of post‐procedural sepsis, and the associated antibiotic burden and risk of development of antibiotic resistance. Transperineal (TP) prostate biopsies performed under local anaesthetic (LA) have been proposed as a possible solution to these issues, with potentially lower infectious complications, and avoidance of need for antibiotic prophylaxis. The European Association of Urology produced guidance in 2023 with ‘weak’ recommendations in favour of LATP biopsy as a new standard of care, citing its safety profile. Both the National Institute for Health and Care Excellence in the UK, and the American Urological Association in the United States, have concluded for now that the body of evidence is inadequate and not offered a similar recommendation. We discuss the available evidence, pros and cons of each technique, and the status of current trials in the field. We believe that clinical equipoise remains necessary, given the disparity in national and international guidelines highlighting the need for large randomised controlled trials to answer the question: is LATP biopsy really better than TRUS biopsy?

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Section: Current Trialsmentioning

confidence: 99%

Perspectives on technology – prostate cancer: is local anaesthetic transperineal prostate biopsy really better than transrectal biopsy?

Berridge,

Omer,

Lopez

et al. 2024

BJU International

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“…Two ongoing European multicenter randomized controlled trialsdPERFECT and TRANSLATEdare designed to compare clinically significant prostate cancer detection rates between TP and TR biopsy. 4,5 Despite a lack of robust evidence for superiority, some have advocated that TP biopsy should completely replace TR biopsy. Given the similar safety profiles based on this trial, perhaps TR biopsy should not be discarded altogether but used selectively in cases where it may be helpful.…”

Section: Editorial Commentmentioning

confidence: 99%

“…Two ongoing European multicenter randomized controlled trials—PERFECT and TRANSLATE—are designed to compare clinically significant prostate cancer detection rates between TP and TR biopsy. 4,5…”

mentioning

confidence: 99%

Editorial Comment

Nusbaum,

Sidana,

Modi

2024

Journal of Urology

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“…However, two of these series derived their transrectal ultrasound-guided prostate biopsy outcomes from procedures performed before they switched their practice to transperineal ultrasound-guided prostate biopsy [19,21], which needs to be taken into account when interpreting these findings. A current effort to gather up-to-date, high level of evidence is expected to result from the PERFECT trial, which is currently recruiting to compare morbidity of both biopsy routes as a secondary outcome [26].…”

Section: Sepsis Rates In Studies Comparing Both Biopsy Approachesmentioning

confidence: 99%

Transperineal vs. transrectal biopsy to reduce postinterventional sepsis

Stangl‐Kremser

Ramaswamy

2023

Current Opinion in Urology

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Purpose of reviewProstate biopsy is commonly performed in men suspected to have prostate cancer. It has traditionally been performed using a transrectal approach, but transperineal prostate biopsy has been increasingly adopted in part because of its lower associated infectious risk. We review recent studies evaluating the rate of potentially life-threatening post-biopsy sepsis and potential preventive strategies.Recent findingsAfter performing a comprehensive literature search, 926 records were screened and 17 studies published in 2021 or 2022 were found to be relevant. Studies varied in periprocedural perineal and transrectal preparation, antibiotic prophylaxis, and definition of sepsis. The sepsis rates after transperineal ultrasound-guided versus transrectal ultrasound-guided biopsy ranged between 0 and 1 versus 0.4 and 9.8%. Mixed efficacy was found for the topical application of antiseptics before transrectal biopsy to decrease postprocedural sepsis. Promising strategies include the use of topical rectal antiseptics before transrectal prostate biopsy and using a rectal swab to guide the antibiotic selection and the route of the biopsy.SummaryThe transperineal approach to biopsy is increasingly used because of lower associated sepsis rates. Our review of the recent literature supports this practice pattern change. Hence, transperineal biopsy should be offered as an option to all men.

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Clinical Trial Protocol for PERFECT: A Randomised Controlled Trial Comparing the Efficiency and Tolerance of Transperineal Fusion Versus Transrectal Imaging-targeted Prostate Biopsies (CCAFU-PR1 Study)

Cited by 17 publications

References 21 publications

Perspectives on technology – prostate cancer: is local anaesthetic transperineal prostate biopsy really better than transrectal biopsy?

Perspectives on technology – prostate cancer: is local anaesthetic transperineal prostate biopsy really better than transrectal biopsy?

Editorial Comment

Transperineal vs. transrectal biopsy to reduce postinterventional sepsis

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