Transperineal magnetic resonance imaging/transrectal ultrasonography fusion prostate biopsy under local anaesthesia: the 'double-freehand' technique.

A TRUS-guided prostate biopsy (PBx) carries inherent risk of rectal bleeding, UTI, sepsis, and potentially under-detecting prostate cancer (PCa) [1]. Although transperineal (TP) PBx has been recommended by some guidelines as a safer alternative, it is underperformed by urologists because of lack of training, exposure, and familiarity with the technique, and burden of special supplies (grids and needle guides) [1-3]. Here, we describe our step-by-step technique and outcomes of ‘double-freehand’ TP MRI/TRUS fusion PBx under local anaesthesia (LA). Consecutive men who underwent multiparametric MRI (mpMRI) followed by TP PBx under LA, from May 2017 to September 2021, from a prospectively maintained PBx database (Institutional Review Board number HS-13-00663) were identified (Fig. S1). Men with a Prostate Imaging-Reporting and Data System (PI-RADS) score 1–2 underwent systematic biopsy (SB), if clinically indicated by elevated PSA, PSA density (PSAD), suspicious DRE or those on active surveillance for PCa [4]. Appendix S1 [4]. Appendix S1 [2]. Video: https://www.dropbox.com/s/c5e3ssx5t0g17wi/TPvideoRevise2.mp4?dl=0. Preoperatively, the acquired mpMRI is uploaded into the imaging fusion system platform Koelis Trinity® (Koelis, Meylan, France). The contouring of the prostate is performed, the targets are registered on the mpMRI suspicious lesions (PI-RADS ≥3), and a three-dimensional (3D) MRI model is created. Intraoperatively, ultrasonography is performed. The 3D TRUS data is acquired, and prostate contouring is performed to create a 3D TRUS model. Contouring of the lesion on both MRI and TRUS was performed by a single urologist (A.L.A. who has performed >2000 MRI/TRUS fusion PBx). The 3D models are then elastic fused, and the final 3D MRI/TRUS fusion model is generated for biopsy. Fig. 1A. With the patient in dorsal lithotomy (Fig. 1B), 10 mL 2% lidocaine gel is instilled into the rectum and DRE is performed. The perineum is then prepped with chlorhexidine and draped. The 3D side-fire endocavity TRUS probe is gently inserted into the patient's rectum. The LA (5 mL lidocaine 0.5% in each side, total of 10 mL) is injected in the perineal skin and subcutaneous tissue approximately 1–2 cm anterior to the rectum and 1–2 cm lateral to the midline (Fig. 2A). The periapical triangle (bounded by levator ani, rhabdosphincter and external anal sphincter muscles) block is achieved by using 30 mL (15 mL in each side) of 0.5% lidocaine in the perineum and periprostatic area, as follows [5]. Under real-time TRUS guidance, an 18-G spinal needle is inserted through a 17-G co-axial introducer needle (Fig. 2B), and carefully advanced towards to the prostatic apex according to the target on the reference imaging. LA is injected in the perineum (Fig. 2C) and the periprostatic tissue (Fig. 2D) through a co-axial needle as the needle is advanced. The 18-G spinal needle is carefully removed, and the co-axial needle sheath is left in place (Fig. 2E) [2, 6]. All patients underwent 12–14 core SB [3]. At least two target biopsy (TB) cores are taken per each PI-RADS 3–5 lesion. A virtual biopsy scan is obtained for imaging reference. To precisely target the lesion, anatomical landmarks are used to compare the real-time TRUS image with the reference scan. When the real-time TRUS image matches the reference image, the biopsy gun is fired, and the prostate is sampled (Fig. 2F). The prostate is 3D scanned and the real trajectory of the needle is confirmed and automatically recorded. Other target cores are performed in a similar fashion for all PI-RADS ≥3 lesions. Appendix S1 [4]. Clinically significant prostate cancer (CSPCa) was defined as Grade Group ≥2 [4]. Operative time was recorded from TRUS probe insertion to removal from the rectum. The periprocedural pain was self-assessed using a numerical rating scale (0–10) immediately after the procedure finished [3]. Complications were recorded up to 30 days after biopsy according to Clavien–Dindo classification [3]. Appendix S1. Overall, out of 241 TP PBx cases in our database, 96 patients met the inclusion criteria (Fig. S1). The median (interquartile range [IQR]) age was 68 (62–72) years; PSA level 7.84 (5.50–10.23) ng/mL; PSAD 0.13 (0.09–0.21) ng/mL2, prostate volume 56 (35–71) mL; number of mpMRI suspicious lesions 1 (0–1), and lesion size on MRI was 14 (9–18) mm. DRE was suspicious for PCa in 20 (21%) men. Overall, the MRI showed 28% PI-RADS 1–2; 18% PI-RADS 3; 26% PI-RADS 4; and 28% PI-RADS 5 index lesion (Table S1). The PCa and CSPCa detection rates were 52% and 3.7% for PI-RADS 1–2, 53% and 47% for PI-RADS 3, 81% and 71% for PI-RADS 4–5, respectively (Table S2). PCa detection, CSPCa detection, maximum cancer core length and involvement were significantly higher for TB than SB in men with PI-RADS 4–5. Age, PSAD, suspicion DRE, and the number of suspicious lesions on MRI were independent predictors for CSPCa (Table S3). The 30-day complication rate was 2.1%. Urinary retention was observed in 1.0% of the patients. All complications were Clavien–Dindo Grade I. There was no UTI, sepsis, or rectal bleeding (Table S4). The median (IQR) operative time and self-assessment of pain score during TP PBx were 22.5 (19–30) min and 3 (2–5), respectively. There were no aborted cases. The PCa and CSPCa detection, the self-assessed patients’ reported pain, as well as the complication rate and operative time were similar to those reported in the literature [2, 3, 6, 7]. This technique is accurate, safe, and well-tolerated by the patients. With the technique described here, we addressed several limitations of TP PBx intending to simplify, streamline, and reduce the cost of TP PBx. There are different techniques demonstrating feasibility and patient's tolerability for TP PBx under LA [5]. We used a modified periapical triangle block with a co-axial needle. In fact, two randomised trials compared TP PBx with vs without co-axial needle and demonstrated that TP PBx with a co-axial needle was significantly less painful [5, 6]. There are several ways for needle guidance during TP PBx (Fig. 3, Table S5). The terminology ‘double-freehand’ is unique and the only technique that both operator's hands have completely full freedom of movement. The Camprobe may add the benefit of keeping the co-axial needle in place [8]. However, it might add costs and may not be widely available. We adopted the double-freehand technique as it provides several advantages: (i) it is cost-effective and there is no need for any additional device or equipment/supply; (ii) wide freedom of movement and angles; (iii) less painful in combination with the co-axial needle technique as discussed above [8]. The main disadvantage is to manually align both the probe and the biopsy needle axis. This study has limitations. This is a relatively small number of patients from a single centre without a control group or randomisation. Nevertheless, this study reports outcomes of self-taught urologist transitioning from a transrectal to a TP PBx approach. Furthermore, the step-by-step video demonstrates in detail the double-freehand technique of TP MRI/TRUS fusion PBx under LA. With this, we hope to educate and encourage physicians performing TP PBx, although starting with TP PBx under sedation during the learning phase may be an option. We demonstrated that the technique of the double-freehand TP MRI/TRUS fusion PBx under LA is accurate and well-tolerated by the patients. None. This study was funded in part by the R01 grant CA205058-01 from the National Institutes of Health/National Cancer Institute (I.S.G. and A.L.A.). Andre Luis Abreu is consulting physician for Koelis. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was performed under Institutional Review Board (IRB# HS-13-00663) approval. Fig. S1. Flowchart of cohort selection. Appendix S1. Supplementary methods. Table S1. Demographics of TP MRI/TRUS fusion PBx under LA. Table S2. Outcomes of TP MRI/TRUS fusion PBx under LA. Table S3. Uni- and multivariable analysis for CSPCa detection on TP MRI/TRUS fusion PBx under LA. Table S4. The 30-day complications for MRI/TRUS fusion TP PBx under LA. Table S5. Summary of advantages and disadvantages of different techniques for TP PBx. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.