Targeted Versus Targeted Plus Random Transperineal Prostate Biopsy in patients with a single lesion on MRI: Is There Added Value?

Targeted Versus Targeted Plus Random Transperineal Prostate Biopsy in patients with a single lesion on MRI: Is There Added Value? | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Targeted Versus Targeted Plus Random Transperineal Prostate Biopsy in patients with a single lesion on MRI: Is There Added Value? Oussama G. Nasrallah, Maya T. Herrera, Rami W. Nasr, Mohammad W. Fawaz, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6950274/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Standardization of multi-parametric MRI (mp-MRI) prior to prostate biopsy and the incorporation of ultrasound fusion allowed precise and accurate targeted prostate biopsies. Random biopsies, still performed as routine, are taken from the ipsilateral and contralateral side of the prostatic lesion. We aim to determine the added value of systematic biopsies (SB) compared to targeted biopsy (TB) only in patients with a single lesion on mp-MRI. Methods : From July 2019 to January 2024, 196 of 464 patients had a single unilateral MRI lesion underwent target and random biopsy under MRI-Ultrasound fusion using KOELIS Trinity ® MRI TPUS Biopsy. Biopsy results of TB alone, SB (targeted and random biopsies from both sides), TB+ipsilateral random biopsy (TB+ipsi), and TB+contralateral random biopsy (TB+contra) were analyzed. Gleason score and Grade group system (1-5) were utilized. Clinically significant PCa (csPCa) was defined as Gleason score > 6 or Grade Group ≥ 2. McNemar test was used to compare Cancer detection between these groups in addition to cancer detection in each Grade Group and PIRADS score. Result : Prostate cancer detection rate in TB alone was 54.6% compared to SB (58.7%) (p= 0.005). Also, TB+ipsi had a detection rate of 56.6% (p= 0.046) and TB+contra of 57.1% p=0.025 when compared to TB alone. For csPCa, only SB and TB+contra showed significant increase in cancer detection (p value: SB= 0.01, TB+contra=0.046) when compared to TB alone. When comparing TB, SB, TB+Ipsi, TB+contra according to the PIRADS score of the single lesion, there was no significant difference in patients with a single PIRADS 5 or PIRADS 3 lesion. However, there was significance in PIRADS 4 lesions (p=0.014), in SB (52.7%) compared to TB (44.6%). Conclusion : SB and TB+contra seem to have a benefit in diagnosis of csPCa in patients with a single lesion detected on mp-MRI. SB seems to have a significant benefit in the diagnosis of prostate cancer in patients with a single PIRADS 4 lesion on mp-MRI. There is no benefit from taking random biopsies in patients with a single PIRADS 5 lesion. Introduction Prostate cancer is the most common non-cutaneou cancer and the second leading cause of cancer mortality in men in the United states in the year of 2025 ( 1 ). The diagnosis of prostate cancer is done using Ultrasound guided transperineal or transrectal biopsy with the use of MRI-Ultrasound fusion for precise targeting of prostate lesions.( 2 ) Transperineal biopsy is gaining more popularity with the advantage of decreased use of antibiotics, risk of infection and stable and precise targeting. ( 2 ) Patients undergoing mp-MRI of the prostate found to have a lesion underwent targeted MRI-Ultrasound fusion biopsy of that lesion with 3–5 cores along with ipsilateral and contralateral random biopsies which provide precise sampling with benefit over the conventional cognitive saturation biopsy. ( 3 , 4 ) The increasing use of MRI targeted biopsy for a unifocal prostate lesion raised the question of the true need of sampling the ipsilateral and contralateral regions of the prostate. Several studies have demonstrated minimal increase in the detection of clinically significant prostate cancer (csPCa) (less than 5%) and the diagnosis of clinically insignificant prostate cancer (ciPCa). ( 4 ) Invisible lesions on MRI that could contribute to the increased detection of csPC, raised the debate of performing contralateral biopsies for patients with a unilateral lesion on mpMRI. ( 5 , 6 ) Additionally, peri-lesional biopsy increased the detection of csPC in the periphery of lesion on MRI called the penumbra. ( 7 , 8 ) The study examines the contribution of ipsilateral and contralateral prostate biopsies in patients with a single lesion detected on mpMRI in the diagnosis of prostate cancer and csPCa. Materials and Methods A total of 464 patients had Trans-perineal biopsies with MR fusion using KOELIS Trinity® MRI TPUS Biopsy. 196/464 patients had a single unilateral MRI lesion. Target and random biopsy were performed between July 2019 and January 2024. The detection of prostate cancer (PCa) and csPCa was compared between Biopsy results of Target biopsy alone (TB), Systematic biopsy (SB) (targeted and random cores from both sides), TB + ipsilateral-random biopsy (TB + ipsi), and TB + contralateral-random biopsy (TB + contra). The detection of significant prostate cancer was identified using TB as a reference. Cancer risk category was assessed using the grade group system, based on Gleason scores, with Grade Group 1 indicating low-grade cancer and Grade Groups 2–5 indicating higher grades. csPCa was defined as Gleason score > 6 or Grade Group ≥ 2. ( 9 ) Scoring of the lesion seen on mpMRI was done by experienced radiologists according to the Prostate Imaging-Reporting and Data System (PI-RADS) version 2.1 criteria( 10 ). All men with PIRADS 4 and PIRADS 5 lesions were scheduled for biopsy along with selected PIRADS 3 patients. These men were either biopsy naïve, having a repeat biopsy for PSA elevation, and some were monitored on active surveillance protocol. All biopsies were performed Transperineally using the KOELIS Trinity® MRI TPUS platform. Patients were placed in lithotomy position and light sedation was administered by the anesthesia team. The perineal skin was prepped and local anesthesia was administered to the areas of intended biopsy needle entry. The Trans-rectal Ultrasound probe was fixed to the stepper and then inserted into the rectum and adjusted in an accurate cranio-caudal position. Then a brachytherapy square or linear grid was attached to the transrectal probe around 1cm away from the perineal skin. The pre-processed 3D MRI images of the prostate gland were fused with the acquired 3D ultrasound scan using the KOELIS Trinity® MRI TPUS software. Men with a unilateral MRI lesion underwent a minimum of four targeted cores per lesion plus a minimum of six to seven ipsilateral and contralateral SB cores ( 11 ). Men with negative MRI findings, cognitive biopsy, absent MRI reports, or with multiple MRI lesions were excluded from the study. Biopsy cores were collected and labeled separately, and reporting was done by expert pathologists according to the International Society of UroPathology (ISUP) GG consensus recommendations ( 9 ). McNemar test was used to compare cancer detection based on the location of the random biopsy. Result Prostate cancer was diagnosed in 115 patients out of 196 patients (58.7%). Using the McNemar test, we examined the contribution of prostate cancer diagnosis of the random biopsies compared to the target biopsy alone. TB alone yielded 54.6% compared to SB (58.7%) which was found to be statistically significant (p = 0.005). Also, TB + ipsi had a detection rate of 56.6% (p = 0.046) and TB + contra of 57.1% p = 0.025 when compared to TB alone as shown in Table 1. CsPCa was diagnosed in 101 patients out of 196 (51.5%). SB and TB + contra showed significant increase in cancer detection (p value: SB = 0.01, TB + contra = 0.046) when compared to TB alone as shown in Table 1. Patients were grouped according to the PIRADS score. 27 patients had a PIRADS 3 lesion in which SB, TB + Ipsi, and TB + contra did not show benefit in prostate cancer diagnosis compared to TB alone. 59 patients had a PIRADS 5 lesion, and there was no statistically significant benefit for random biopsies in prostate cancer detection when compared to TB alone. However, in PIRADS 4 lesions (74 patients), there was a significant benefit in cancer detection in SB (52.7%, p = 0.014) compared to TB (44.6%) as shown in Table 2. Discussion Our findings suggest that there is a 3% and 2% increase in the detection of csPCa in patients undergoing SB and TB + contra respectively compared to TB alone in patients with single lesion on MRI. However, the data presented also suggests that patients with a PIRADS 5 lesion on mp-MRI do not benefit from random biopsies in terms of prostate cancer diagnosis. Yet, patients with a PIRADS 4 lesion significantly benefit from SB for prostate cancer detection. Finally, the data collected for PIRADS 3 lesions yielded low number of prostate cancer and requires a larger sample to draw conclusions due to the low yield of prostate cancer in such lesions of around 10–15%. In patients with single lesion that are identified as candidates for focal therapy, SB will continue to be performed at this time. Multiple studies have been conducted to investigate the role of the standard systematic saturation biopsy with TB and TB plus peri-lesional biopsy. Most studies are in line with our findings that there is increased detection of prostate cancer overall in SB however, minimal increase in csPCa detection as shown in a Cochrane meta-analysis ( 4 ) which showed an added value of SB to MRI-targeted cores of ~ 5% in biopsy-naïve men. One study investigated the role of contralateral prostate biopsies in patients with a single lesion on MRI; results showed an increase in 1% of csPCa all of which were intermediate favorable amenable to active surveillance. ( 12 ) Another study performed by Daniffel et al, additional SB provided a 6% additional csPCa. When looking into the subgroup analysis, SB had a significantly lower risk of detection of csPCa in patients with a PIRADS 5 lesion compared to MRI-TB, than PIRADS 3 and PIRADS 4 lesions. ( 13 ) An additional study by Ahdoot et al showed that patients with a PIRADS 5 lesion would have minimal benefit from detection of csPCa when adding SB with a mere increase of 2.5%. However, in PIRADS 3 and 4 cases, SB added 8% and 7.5% increased detection of csPCa respectively, than TB alone.( 14 ) This further stresses on the low csPCa contribution of SB compared to TB specially in patients with a PIRADS 5 lesion. As for the role of ipsilateral biopsy, we found that there was no significant benefit in diagnosis of csPCa with increased diagnosis of prostate cancer overall by only 2%. A study by Hagens et al showed that TB plus perilesional biopsy may miss around 3% of csPCa compared to MRI-TB plus SB.( 8 ) Further analysis was done on the contribution of SB compared to TB plus perilesional and showed increased diagnosis of clinically insignificant prostate cancer (ciPCa) in SB. Therefore, omitting SB would reduce the diagnosis of ciPCa. ( 8 ) Another study showed that 90% of csPCa are located in the peri-lesional region.( 15 ) These studies support taking biopsies in a 1cm radius around the lesion and not only from the lesion itself. There are several limitations to this study. First, it is a retrospective chart review study and lacks randomization of patients into two groups: TB and TB plus SB. Second, the sample size limits the study to only 196 patients and a low number of single lesions PIRADS 3 lesions which may also be monitored through PSA and MRI without the need of biopsy. Third, despite the high level of expertise of radiologists and pathologists, there is variation between readers and validation was not made which may upgrade or downgrade lesions and cancers. Finally, errors in the performance of the biopsy are expected despite high expertise in the procedure. Conclusion SB and TB + contra seem to have a benefit in diagnosis of csPCa in patients with a single lesion detected on mp-MRI. SB seems to have a significant benefit in the diagnosis of prostate cancer in patients with a single PIRADS 4 lesion on mp-MRI, however there is no benefit from taking random biopsies in patients with a single PIRADS 5 lesion. Declarations Authors’ contributions: Conceptualization: M. B. Data Collection: O. N., M. H., R. N., M. F., M. W., M. E. M., M. B. Writing – Original Draft Preparation: O. N., M. H., R. N. Writing – Review & Editing: M. W., M. E. M., A. E. H., B. B., W. W., H. M., R. K. Discussion Writing: M. W., M. E. M. Review & Editing: A. E. H., B. B., W. W., H. M., R. K. Prepared tables: O. N., M. H. Data Analysis: M. H., M. A. H. Human Ethics and Consent to Participate: This study was approved by the local ethical committee (BIO: 2024-0013) at our institution. There was no need for consent from patients as this is a retrospective chart review study and the patients were not contacted during the study. Acknowledgements: Not applicable. Funding: This study did not receive any funding or grant from any source. Competing interest: None. The authors declare no competing interests. Availability of data and materials: The data collected can be provided upon request if needed. References Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45. Gravestock P, Shaw M, Veeratterapillay R, Heer R. Prostate Cancer Diagnosis: Biopsy Approaches. Exon Publications; 2022. p. 141-68. Gandaglia G, Ploussard G, Valerio M, Mattei A, Fiori C, Roumiguié M, et al. The Key Combined Value of Multiparametric Magnetic Resonance Imaging, and Magnetic Resonance Imaging-targeted and Concomitant Systematic Biopsies for the Prediction of Adverse Pathological Features in Prostate Cancer Patients Undergoing Radical Prostatectomy. Eur Urol. 2020;77(6):733-41. Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, et al. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019;4(4):Cd012663. Malewski W, Milecki T, Tayara O, Poletajew S, Kryst P, Tokarczyk A, et al. Role of Systematic Biopsy in the Era of Targeted Biopsy: A Review. Curr Oncol. 2024;31(9):5171-94. Saner YM, Wiesenfarth M, Weru V, Ladyzhensky B, Tschirdewahn S, Püllen L, et al. Detection of Clinically Significant Prostate Cancer Using Targeted Biopsy with Four Cores Versus Target Saturation Biopsy with Nine Cores in Transperineal Prostate Fusion Biopsy: A Prospective Randomized Trial. Eur Urol Oncol. 2023;6(1):49-55. Noujeim JP, Belahsen Y, Lefebvre Y, Lemort M, Deforche M, Sirtaine N, et al. Optimizing multiparametric magnetic resonance imaging-targeted biopsy and detection of clinically significant prostate cancer: the role of perilesional sampling. Prostate Cancer Prostatic Dis. 2023;26(3):575-80. Hagens MJ, Noordzij MA, Mazel JW, Jager A, Boellaard TN, Tielbeek JAW, et al. An Magnetic Resonance Imaging-directed Targeted-plus-perilesional Biopsy Approach for Prostate Cancer Diagnosis: "Less Is More". Eur Urol Open Sci. 2022;43:68-73. Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016;40(2):244-52. Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, et al. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019;76(3):340-51. Barrett T, de Rooij M, Giganti F, Allen C, Barentsz JO, Padhani AR. Quality checkpoints in the MRI-directed prostate cancer diagnostic pathway. Nat Rev Urol. 2023;20(1):9-22. Boesen L, Nørgaard N, Bisbjerg R, Løgager V. Clinical value of contralateral biopsies in men with unilateral MRI foci undergoing targeted biopsy. BJU International. 2025;135(3):465-72. Deniffel D, Perlis N, Ghai S, Girgis S, Healy GM, Fleshner N, et al. Prostate biopsy in the era of MRI-targeting: towards a judicious use of additional systematic biopsy. Eur Radiol. 2022;32(11):7544-54. Ahdoot M, Lebastchi AH, Long L, Wilbur AR, Gomella PT, Mehralivand S, et al. Using Prostate Imaging-Reporting and Data System (PI-RADS) Scores to Select an Optimal Prostate Biopsy Method: A Secondary Analysis of the Trio Study. Eur Urol Oncol. 2022;5(2):176-86. Brisbane WG, Priester AM, Ballon J, Kwan L, Delfin MK, Felker ER, et al. Targeted Prostate Biopsy: Umbra, Penumbra, and Value of Perilesional Sampling. Eur Urol. 2022;82(3):303-10. Tables Tables 1 to 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1singlelesion.jpg Table 1: Prostate cancer, and csPCa detection rates in TB, SB, TB+ipsi, TB+contra. Table2singlelesion.jpg Table 2: PIRADS score and Grade Group distribution depending on the biopsy strategy Table3singlelesion.jpg Table 3: Crosstabulation of PIRADS Score for Main Lesion and Gleason Score Categories Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6950274","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":507771473,"identity":"491137f6-789e-4e3b-a1a1-4f50d795749a","order_by":0,"name":"Oussama G. Nasrallah","email":"","orcid":"","institution":"American University of Beirut Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Oussama","middleName":"G.","lastName":"Nasrallah","suffix":""},{"id":507771474,"identity":"8d87e0bb-8cd7-4a88-bba0-7d44a3356032","order_by":1,"name":"Maya T. 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Bulbul","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAs0lEQVRIiWNgGAWjYDACCfYDBz4wMCQAmQYMDAUHiNHCk/hwBlyLAVFaGIyNeUjSoju7IU3apuZwHgN78zYJBoM7hLWY3Tl4TDrn2OFiBp5jZUAtz4jQciMhTTqH7XBig0SOGVDLYaK0mElb/ANqkX9DvBZjY8Y2kC08xGq5cybxYW9fejEbT1qxRQJRfrndfuDAj2/Wefzshzfe+FBBRIjBARuISCBBwygYBaNgFIwCPAAAsjM7/MxfaLoAAAAASUVORK5CYII=","orcid":"","institution":"American University of Beirut Medical Center","correspondingAuthor":true,"prefix":"","firstName":"Muhammad","middleName":"A.","lastName":"Bulbul","suffix":""}],"badges":[],"createdAt":"2025-06-22 15:08:25","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6950274/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6950274/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":100379900,"identity":"a9a4e36e-8c49-42ea-895e-a81674f9df5a","added_by":"auto","created_at":"2026-01-16 09:53:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":429400,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6950274/v1/bf3694ed-774f-4ecf-a6cc-e1a4e3e83d0d.pdf"},{"id":90612223,"identity":"44670175-457b-4d7f-90da-f43b7517080a","added_by":"auto","created_at":"2025-09-04 17:20:45","extension":"jpg","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":103073,"visible":true,"origin":"","legend":"\u003cp\u003eTable 1: Prostate cancer, and csPCa detection rates in TB, SB, TB+ipsi, TB+contra.\u003c/p\u003e","description":"","filename":"Table1singlelesion.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6950274/v1/48a5d54e05c06fade119f088.jpg"},{"id":90612044,"identity":"19d1bbd1-c523-4568-bd22-e929a03cc65d","added_by":"auto","created_at":"2025-09-04 17:12:45","extension":"jpg","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":134619,"visible":true,"origin":"","legend":"\u003cp\u003eTable 2: PIRADS score and Grade Group distribution depending on the biopsy strategy\u003c/p\u003e","description":"","filename":"Table2singlelesion.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6950274/v1/03d8b7d10999463a6846e97b.jpg"},{"id":90612046,"identity":"5210728d-e95c-4135-b423-8092d012772d","added_by":"auto","created_at":"2025-09-04 17:12:45","extension":"jpg","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":89793,"visible":true,"origin":"","legend":"\u003cp\u003eTable 3: Crosstabulation of PIRADS Score for Main Lesion and Gleason Score Categories\u003c/p\u003e","description":"","filename":"Table3singlelesion.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6950274/v1/f45356da0a2da164a0355d0b.jpg"}],"financialInterests":"No competing interests reported.","formattedTitle":"Targeted Versus Targeted Plus Random Transperineal Prostate Biopsy in patients with a single lesion on MRI: Is There Added Value?","fulltext":[{"header":"Introduction","content":"\u003cp\u003eProstate cancer is the most common non-cutaneou cancer and the second leading cause of cancer mortality in men in the United states in the year of 2025 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The diagnosis of prostate cancer is done using Ultrasound guided transperineal or transrectal biopsy with the use of MRI-Ultrasound fusion for precise targeting of prostate lesions.(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Transperineal biopsy is gaining more popularity with the advantage of decreased use of antibiotics, risk of infection and stable and precise targeting. (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Patients undergoing mp-MRI of the prostate found to have a lesion underwent targeted MRI-Ultrasound fusion biopsy of that lesion with 3\u0026ndash;5 cores along with ipsilateral and contralateral random biopsies which provide precise sampling with benefit over the conventional cognitive saturation biopsy. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) The increasing use of MRI targeted biopsy for a unifocal prostate lesion raised the question of the true need of sampling the ipsilateral and contralateral regions of the prostate. Several studies have demonstrated minimal increase in the detection of clinically significant prostate cancer (csPCa) (less than 5%) and the diagnosis of clinically insignificant prostate cancer (ciPCa). (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Invisible lesions on MRI that could contribute to the increased detection of csPC, raised the debate of performing contralateral biopsies for patients with a unilateral lesion on mpMRI. (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) Additionally, peri-lesional biopsy increased the detection of csPC in the periphery of lesion on MRI called the penumbra. (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) The study examines the contribution of ipsilateral and contralateral prostate biopsies in patients with a single lesion detected on mpMRI in the diagnosis of prostate cancer and csPCa.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eA total of 464 patients had Trans-perineal biopsies with MR fusion using KOELIS Trinity® MRI TPUS Biopsy. 196/464 patients had a single unilateral MRI lesion. Target and random biopsy were performed between July 2019 and January 2024. The detection of prostate cancer (PCa) and csPCa was compared between Biopsy results of Target biopsy alone (TB), Systematic biopsy (SB) (targeted and random cores from both sides), TB + ipsilateral-random biopsy (TB + ipsi), and TB + contralateral-random biopsy (TB + contra). The detection of significant prostate cancer was identified using TB as a reference. Cancer risk category was assessed using the grade group system, based on Gleason scores, with Grade Group 1 indicating low-grade cancer and Grade Groups 2–5 indicating higher grades. csPCa was defined as Gleason score \u0026gt; 6 or Grade Group ≥ 2. (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eScoring of the lesion seen on mpMRI was done by experienced radiologists according to the Prostate Imaging-Reporting and Data System (PI-RADS) version 2.1 criteria(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). All men with PIRADS 4 and PIRADS 5 lesions were scheduled for biopsy along with selected PIRADS 3 patients. These men were either biopsy naïve, having a repeat biopsy for PSA elevation, and some were monitored on active surveillance protocol. All biopsies were performed Transperineally using the KOELIS Trinity® MRI TPUS platform. Patients were placed in lithotomy position and light sedation was administered by the anesthesia team. The perineal skin was prepped and local anesthesia was administered to the areas of intended biopsy needle entry. The Trans-rectal Ultrasound probe was fixed to the stepper and then inserted into the rectum and adjusted in an accurate cranio-caudal position. Then a brachytherapy square or linear grid was attached to the transrectal probe around 1cm away from the perineal skin. The pre-processed 3D MRI images of the prostate gland were fused with the acquired 3D ultrasound scan using the KOELIS Trinity® MRI TPUS software.\u003c/p\u003e\u003cp\u003eMen with a unilateral MRI lesion underwent a minimum of four targeted cores per lesion plus a minimum of six to seven ipsilateral and contralateral SB cores (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Men with negative MRI findings, cognitive biopsy, absent MRI reports, or with multiple MRI lesions were excluded from the study.\u003c/p\u003e\u003cp\u003eBiopsy cores were collected and labeled separately, and reporting was done by expert pathologists according to the International Society of UroPathology (ISUP) GG consensus recommendations (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). McNemar test was used to compare cancer detection based on the location of the random biopsy.\u003c/p\u003e"},{"header":"Result","content":"\u003cp\u003eProstate cancer was diagnosed in 115 patients out of 196 patients (58.7%). Using the McNemar test, we examined the contribution of prostate cancer diagnosis of the random biopsies compared to the target biopsy alone. TB alone yielded 54.6% compared to SB (58.7%) which was found to be statistically significant (p = 0.005). Also, TB + ipsi had a detection rate of 56.6% (p = 0.046) and TB + contra of 57.1% p = 0.025 when compared to TB alone as shown in Table\u0026nbsp;1.\u003c/p\u003e\u003cp\u003eCsPCa was diagnosed in 101 patients out of 196 (51.5%). SB and TB + contra showed significant increase in cancer detection (p value: SB = 0.01, TB + contra = 0.046) when compared to TB alone as shown in Table\u0026nbsp;1.\u003c/p\u003e\u003cp\u003e Patients were grouped according to the PIRADS score. 27 patients had a PIRADS 3 lesion in which SB, TB + Ipsi, and TB + contra did not show benefit in prostate cancer diagnosis compared to TB alone. 59 patients had a PIRADS 5 lesion, and there was no statistically significant benefit for random biopsies in prostate cancer detection when compared to TB alone. However, in PIRADS 4 lesions (74 patients), there was a significant benefit in cancer detection in SB (52.7%, p = 0.014) compared to TB (44.6%) as shown in Table\u0026nbsp;2.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur findings suggest that there is a 3% and 2% increase in the detection of csPCa in patients undergoing SB and TB\u0026thinsp;+\u0026thinsp;contra respectively compared to TB alone in patients with single lesion on MRI. However, the data presented also suggests that patients with a PIRADS 5 lesion on mp-MRI do not benefit from random biopsies in terms of prostate cancer diagnosis. Yet, patients with a PIRADS 4 lesion significantly benefit from SB for prostate cancer detection. Finally, the data collected for PIRADS 3 lesions yielded low number of prostate cancer and requires a larger sample to draw conclusions due to the low yield of prostate cancer in such lesions of around 10\u0026ndash;15%. In patients with single lesion that are identified as candidates for focal therapy, SB will continue to be performed at this time.\u003c/p\u003e\u003cp\u003eMultiple studies have been conducted to investigate the role of the standard systematic saturation biopsy with TB and TB plus peri-lesional biopsy. Most studies are in line with our findings that there is increased detection of prostate cancer overall in SB however, minimal increase in csPCa detection as shown in a Cochrane meta-analysis (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) which showed an added value of SB to MRI-targeted cores of ~\u0026thinsp;5% in biopsy-na\u0026iuml;ve men. One study investigated the role of contralateral prostate biopsies in patients with a single lesion on MRI; results showed an increase in 1% of csPCa all of which were intermediate favorable amenable to active surveillance. (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) Another study performed by Daniffel et al, additional SB provided a 6% additional csPCa. When looking into the subgroup analysis, SB had a significantly lower risk of detection of csPCa in patients with a PIRADS 5 lesion compared to MRI-TB, than PIRADS 3 and PIRADS 4 lesions. (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) An additional study by Ahdoot et al showed that patients with a PIRADS 5 lesion would have minimal benefit from detection of csPCa when adding SB with a mere increase of 2.5%. However, in PIRADS 3 and 4 cases, SB added 8% and 7.5% increased detection of csPCa respectively, than TB alone.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) This further stresses on the low csPCa contribution of SB compared to TB specially in patients with a PIRADS 5 lesion.\u003c/p\u003e\u003cp\u003eAs for the role of ipsilateral biopsy, we found that there was no significant benefit in diagnosis of csPCa with increased diagnosis of prostate cancer overall by only 2%. A study by Hagens et al showed that TB plus perilesional biopsy may miss around 3% of csPCa compared to MRI-TB plus SB.(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) Further analysis was done on the contribution of SB compared to TB plus perilesional and showed increased diagnosis of clinically insignificant prostate cancer (ciPCa) in SB. Therefore, omitting SB would reduce the diagnosis of ciPCa. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) Another study showed that 90% of csPCa are located in the peri-lesional region.(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) These studies support taking biopsies in a 1cm radius around the lesion and not only from the lesion itself.\u003c/p\u003e\u003cp\u003eThere are several limitations to this study. First, it is a retrospective chart review study and lacks randomization of patients into two groups: TB and TB plus SB. Second, the sample size limits the study to only 196 patients and a low number of single lesions PIRADS 3 lesions which may also be monitored through PSA and MRI without the need of biopsy. Third, despite the high level of expertise of radiologists and pathologists, there is variation between readers and validation was not made which may upgrade or downgrade lesions and cancers. Finally, errors in the performance of the biopsy are expected despite high expertise in the procedure.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eSB and TB\u0026thinsp;+\u0026thinsp;contra seem to have a benefit in diagnosis of csPCa in patients with a single lesion detected on mp-MRI. SB seems to have a significant benefit in the diagnosis of prostate cancer in patients with a single PIRADS 4 lesion on mp-MRI, however there is no benefit from taking random biopsies in patients with a single PIRADS 5 lesion.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: M. B.\u003c/p\u003e\n\u003cp\u003eData Collection: O. N., M. H., R. N., M. F., M. W., M. E. M., M. B.\u003c/p\u003e\n\u003cp\u003eWriting \u0026ndash; Original Draft Preparation: O. N., M. H., R. N.\u003c/p\u003e\n\u003cp\u003eWriting \u0026ndash; Review \u0026amp; Editing: M. W., M. E. M., A. E. H., B. B., W. W., H. M., R. K.\u003c/p\u003e\n\u003cp\u003eDiscussion Writing: M. W., M. E. M.\u003c/p\u003e\n\u003cp\u003eReview \u0026amp; Editing: A. E. H., B. B., W. W., H. M., R. K.\u003c/p\u003e\n\u003cp\u003ePrepared tables: O. N., M. H.\u003c/p\u003e\n\u003cp\u003eData Analysis: M. H., M. A. H.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to Participate:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the local ethical committee (BIO:\u0026nbsp;2024-0013) at our institution. There was no need for consent from patients as this is a retrospective chart review study and the patients were not contacted during the study.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study did not receive any funding or grant from any source.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interest:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone. The authors declare no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data collected can be provided upon request if needed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSiegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45.\u003c/li\u003e\n\u003cli\u003eGravestock P, Shaw M, Veeratterapillay R, Heer R. Prostate Cancer Diagnosis: Biopsy Approaches. Exon Publications; 2022. p. 141-68.\u003c/li\u003e\n\u003cli\u003eGandaglia G, Ploussard G, Valerio M, Mattei A, Fiori C, Roumigui\u0026eacute; M, et al. The Key Combined Value of Multiparametric Magnetic Resonance Imaging, and Magnetic Resonance Imaging-targeted and Concomitant Systematic Biopsies for the Prediction of Adverse Pathological Features in Prostate Cancer Patients Undergoing Radical Prostatectomy. Eur Urol. 2020;77(6):733-41.\u003c/li\u003e\n\u003cli\u003eDrost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, et al. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019;4(4):Cd012663.\u003c/li\u003e\n\u003cli\u003eMalewski W, Milecki T, Tayara O, Poletajew S, Kryst P, Tokarczyk A, et al. Role of Systematic Biopsy in the Era of Targeted Biopsy: A Review. Curr Oncol. 2024;31(9):5171-94.\u003c/li\u003e\n\u003cli\u003eSaner YM, Wiesenfarth M, Weru V, Ladyzhensky B, Tschirdewahn S, P\u0026uuml;llen L, et al. Detection of Clinically Significant Prostate Cancer Using Targeted Biopsy with Four Cores Versus Target Saturation Biopsy with Nine Cores in Transperineal Prostate Fusion Biopsy: A Prospective Randomized Trial. Eur Urol Oncol. 2023;6(1):49-55.\u003c/li\u003e\n\u003cli\u003eNoujeim JP, Belahsen Y, Lefebvre Y, Lemort M, Deforche M, Sirtaine N, et al. Optimizing multiparametric magnetic resonance imaging-targeted biopsy and detection of clinically significant prostate cancer: the role of perilesional sampling. Prostate Cancer Prostatic Dis. 2023;26(3):575-80.\u003c/li\u003e\n\u003cli\u003eHagens MJ, Noordzij MA, Mazel JW, Jager A, Boellaard TN, Tielbeek JAW, et al. An Magnetic Resonance Imaging-directed Targeted-plus-perilesional Biopsy Approach for Prostate Cancer Diagnosis: \u0026quot;Less Is More\u0026quot;. Eur Urol Open Sci. 2022;43:68-73.\u003c/li\u003e\n\u003cli\u003eEpstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016;40(2):244-52.\u003c/li\u003e\n\u003cli\u003eTurkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, et al. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019;76(3):340-51.\u003c/li\u003e\n\u003cli\u003eBarrett T, de Rooij M, Giganti F, Allen C, Barentsz JO, Padhani AR. Quality checkpoints in the MRI-directed prostate cancer diagnostic pathway. Nat Rev Urol. 2023;20(1):9-22.\u003c/li\u003e\n\u003cli\u003eBoesen L, N\u0026oslash;rgaard N, Bisbjerg R, L\u0026oslash;gager V. Clinical value of contralateral biopsies in men with unilateral MRI foci undergoing targeted biopsy. BJU International. 2025;135(3):465-72.\u003c/li\u003e\n\u003cli\u003eDeniffel D, Perlis N, Ghai S, Girgis S, Healy GM, Fleshner N, et al. Prostate biopsy in the era of MRI-targeting: towards a judicious use of additional systematic biopsy. Eur Radiol. 2022;32(11):7544-54.\u003c/li\u003e\n\u003cli\u003eAhdoot M, Lebastchi AH, Long L, Wilbur AR, Gomella PT, Mehralivand S, et al. Using Prostate Imaging-Reporting and Data System (PI-RADS) Scores to Select an Optimal Prostate Biopsy Method: A Secondary Analysis of the Trio Study. Eur Urol Oncol. 2022;5(2):176-86.\u003c/li\u003e\n\u003cli\u003eBrisbane WG, Priester AM, Ballon J, Kwan L, Delfin MK, Felker ER, et al. Targeted Prostate Biopsy: Umbra, Penumbra, and Value of Perilesional Sampling. Eur Urol. 2022;82(3):303-10.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6950274/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6950274/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e:\u003cbr\u003e\nStandardization of multi-parametric MRI (mp-MRI) prior to prostate biopsy and the incorporation of ultrasound fusion allowed precise and accurate targeted prostate biopsies. Random biopsies, still performed as routine, are taken from the ipsilateral and contralateral side of the prostatic lesion. We aim to determine the added value of systematic biopsies (SB) compared to targeted biopsy (TB) only in patients with a single lesion on mp-MRI.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eFrom July 2019 to January 2024, 196 of 464 patients had a single unilateral MRI lesion underwent target and random biopsy under MRI-Ultrasound fusion using KOELIS Trinity\u003csup\u003e®\u003c/sup\u003e MRI TPUS Biopsy. Biopsy results of TB alone, SB (targeted and random biopsies from both sides), TB+ipsilateral random biopsy (TB+ipsi), and TB+contralateral random biopsy (TB+contra) were analyzed. Gleason score and Grade group system (1-5) were utilized. Clinically significant PCa (csPCa) was defined as Gleason score \u0026gt; 6 or Grade Group ≥ 2. \u0026nbsp;McNemar test was used to compare Cancer detection between these groups in addition to cancer detection in each Grade Group and PIRADS score.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResult\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eProstate cancer detection rate in TB alone was 54.6% compared to SB (58.7%) (p= 0.005). Also, TB+ipsi had a detection rate of 56.6% (p= 0.046) and TB+contra of 57.1% p=0.025 when compared to TB alone.\u003c/p\u003e\n\u003cp\u003eFor csPCa, only SB and TB+contra showed significant increase in cancer detection (p value: SB= 0.01, TB+contra=0.046) when compared to TB alone.\u003c/p\u003e\n\u003cp\u003eWhen comparing TB, SB, TB+Ipsi, TB+contra according to the PIRADS score of the single lesion, there was no significant difference in patients with a single PIRADS 5 or PIRADS 3 lesion. However, there was significance in PIRADS 4 lesions (p=0.014), in SB (52.7%) compared to TB (44.6%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eSB and TB+contra seem to have a benefit in diagnosis of csPCa in patients with a single lesion detected on mp-MRI. SB seems to have a significant benefit in the diagnosis of prostate cancer in patients with a single PIRADS 4 lesion on mp-MRI. There is no benefit from taking random biopsies in patients with a single PIRADS 5 lesion.\u003c/p\u003e","manuscriptTitle":"Targeted Versus Targeted Plus Random Transperineal Prostate Biopsy in patients with a single lesion on MRI: Is There Added Value?","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-04 17:12:40","doi":"10.21203/rs.3.rs-6950274/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3ffdbd18-64ba-4aab-9ee7-00b5ae54edd7","owner":[],"postedDate":"September 4th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-01-09T19:53:40+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-04 17:12:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6950274","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6950274","identity":"rs-6950274","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}