Abstract
Background
Artificial intelligence ultrasound of prostate (AIUSP)-targeted biopsy has been used for prostate cancer (PCa) diagnosis. The objective of this prospective multi-center head-to-head clinical randomized comparative trail (RCT) is to compare PCa detection rate in the TRUS-guided 12-core standard systematic biopsy (TRUS-SB) group and cognitive fused mpMRI-guided 12-core biopsy (mpMRI) group against AIUSP group.
Methods
Four hundred patients were randomized to three arms and underwent biopsies by TRUS-SB (n = 133), mpMRI (n = 134), and AIUSP (n = 133) between January 2015 and December 2017. In TRUS-SB group, a standard 12-core systematic biopsy was performed. In mpMRI group, mpMRI-suspicious lesions (PI-RADS 3–5) were targeted by 2-core biopsy followed by a 10-core systematic biopsy. Otherwise, 12-core systematic biopsy was performed. In AIUSP group, a 6-core targeted biopsy was performed. The primary endpoint was PCa detection rate.
Results
AIUSP detected the highest rate of PCa (66/133, 49.6%) compared to TRUS-SB (46/133, 34.6%, p = 0.036) and mpMRI (48/134, 35.8%, p = 0.052). Compared to TRUS-SB (35/133, 26.3%) and mpMRI (31/134, 23.1%) groups, clinically significant PCa (csPCa) detection rate was 32.3% (43/133) in AIUSP group. Overall biopsy core positive rate in the TRUS-SB group (11.0%, 176/1598) and in the mpMRI group (12.7%, 204/1608) was significantly lower than that in the AIUSP group (22.7%, 181/798, p < 0.001).
Conclusions
AIUSP detected the highest rate of overall and significant PCa compared to TRUS-SB and mpMRI, and could be used as an alternative to systematic biopsy in the future.
Registration
This trial was registered in ISRCTN (ISRCTN18033113).
Similar content being viewed by others
Abbreviations
- PCa:
-
Prostate cancer
- csPCa:
-
Clinically significant PCa
- RCT:
-
Clinical randomized comparative trail
- AIUSP:
-
Artificial intelligence ultrasound of prostate
- TRUS-SB:
-
TRUS-guided 12-core systematic biopsy
References
Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS (2013) Optimization of initial prostate biopsy in clinical practice: sampling, labeling, and specimen processing. J Urol 189(6):2039–2046
Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S et al (2017) EAU-ESTRO-SIOG guidelines on prostate cancer. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol 71(4):618–629
Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S et al (2021) EAU-EANM-ESTRO-ESUR-SIOG guidelines on prostate cancer-2020 update. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol 79(2):243–262
Cormio L, Scattoni V, Lorusso F, Perrone A, Fino GD, Selvaggio O, Sanguedolce F, Bufo P, Montorsi F, Carrieri G (2014) Prostate cancer detection rates in different biopsy schemes. Which cores for which patients? World J Urol 32(2):341–346
Serag H, Banerjee S, Saebparsy K, Irving S, Wright K, Stearn S, Doble A, Gnanapragasam VJ (2012) Risk profiles of prostate cancers identified from UK primary care using national referral guidelines. Br J Cancer 106(3):436–439
Arsov C, Rabenalt R, Blondin D, Quentin M, Hiester A, Godehardt E, Gabbert HE, Becker N, Antoch G, Albers P et al (2015) Prospective randomized trial comparing magnetic resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal ultrasound-guided prostate biopsy in patients with prior negative biopsies. Eur Urol 68(4):713–720
Wegelin O, Exterkate L, van der Leest M, Kummer JA, Vreuls W, de Bruin PC, Bosch J, Barentsz JO, Somford DM, van Melick HHE (2018) The FUTURE trial: a multicenter randomised controlled trial on target biopsy techniques based on magnetic resonance imaging in the diagnosis of prostate cancer in patients with prior negative biopsies. Eur Urol 75:582–590
Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L et al (2019) Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol 20(1):100–109
Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A et al (2017) Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 389(10071):815–822
Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG (2019) Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev 4:CD012663
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG et al (2018) MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 378(19):1767–1777
Goldberg H, Ahmad AE, Chandrasekar T, Klotz L, Emberton M, Haider MA, Taneja SS, Arora K, Fleshner N, Finelli A et al (2020) Comparison of magnetic resonance imaging and transrectal ultrasound informed prostate biopsy for prostate cancer diagnosis in biopsy naive men: a systematic review and meta-analysis. J Urol 203(6):1085–1093
van Hove A, Savoie PH, Maurin C, Brunelle S, Gravis G, Salem N, Walz J (2014) Comparison of image-guided targeted biopsies versus systematic randomized biopsies in the detection of prostate cancer: a systematic literature review of well-designed studies. World J Urol 32(4):847–858
Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG (2015) Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol 68(3):438–450
Tonttila PP, Lantto J, Paakko E, Piippo U, Kauppila S, Lammentausta E, Ohtonen P, Vaarala MH (2016) Prebiopsy multiparametric magnetic resonance imaging for prostate cancer diagnosis in biopsy-naive men with suspected prostate cancer based on elevated prostate-specific antigen values: results from a randomized prospective blinded controlled trial. Eur Urol 69(3):419–425
Baco E, Rud E, Eri LM, Moen G, Vlatkovic L, Svindland A, Eggesbo HB, Ukimura O (2016) A randomized controlled trial to assess and compare the outcomes of two-core prostate biopsy guided by fused magnetic resonance and transrectal ultrasound images and traditional 12-core systematic biopsy. Eur Urol 69(1):149–156
Loch T, Fulgham PF (2016) Active surveillance challenges in men with prostate cancer: role of imaging today and tomorrow. Eur Urol 69(6):1034–1036
Loch T, Leuschner I, Genberg C, Weichert-Jacobsen K, Kuppers F, Yfantis E, Evans M, Tsarev V, Stockle M (1999) Artificial neural network analysis (ANNA) of prostatic transrectal ultrasound. Prostate 39(3):198–204
Loch T (2007) Computerized transrectal ultrasound (C-TRUS) of the prostate: detection of cancer in patients with multiple negative systematic random biopsies. World J Urol 25(4):375–380
Grabski B, Baeurle L, Loch A, Wefer B, Paul U, Loch T (2011) Computerized transrectal ultrasound of the prostate in a multicenter setup (C-TRUS-MS): detection of cancer after multiple negative systematic random and in primary biopsies. World J Urol 29(5):573–579
Tokas T, Grabski B, Paul U, Baurle L, Loch T (2018) A 12-year follow-up of ANNA/C-TRUS image-targeted biopsies in patients suspicious for prostate cancer. World J Urol 36(5):699–704
Dickinson L, Ahmed HU, Allen C, Barentsz JO, Carey B, Futterer JJ, Heijmink SW, Hoskin PJ, Kirkham A, Padhani AR et al (2011) Magnetic resonance imaging for the detection, localisation, and characterisation of prostate cancer: recommendations from a European consensus meeting. Eur Urol 59(4):477–494
Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ (2012) European Society of Urogenital R: ESUR prostate MR guidelines 2012. Eur Radiol 22(4):746–757
Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM et al (2016) PI-RADS prostate imaging—reporting and data system: 2015, version 2. Eur Urol 69(1):16–40
Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA, Grading C (2016) 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 40(2):244–252
Xie LP, Wang X, Zheng XY, Liu B, Li JF, Wang S (2017) 500—a randomized controlled trial to assess and compare the outcomes of AI-US-CT guided biopsy, transrectal ultrasound guided 12-core systematic biopsy, and mpMRI assisted 12-core systematic biopsy. Eur Urol Suppl 16(3):e865–e866
Strunk T, Decker G, Willinek W, Mueller SC, Rogenhofer S (2014) Combination of C-TRUS with multiparametric MRI: potential for improving detection of prostate cancer. World J Urol 32(2):335–339
Babaian RJ, Toi A, Kamoi K, Troncoso P, Sweet J, Evans R, Johnston D, Chen M (2000) A comparative analysis of sextant and an extended 11-core multisite directed biopsy strategy. J Urol 163(1):152–157
Sonn GA, Fan RE, Ghanouni P, Wang NN, Brooks JD, Loening AM, Daniel BL, To’o KJ, Thong AE, Leppert JT (2019) Prostate magnetic resonance imaging interpretation varies substantially across radiologists. Eur Urol Focus 5(4):592–599
Harland N, Russo GI, Kaufmann S, Amend B, Rausch S, Erne E, Scharpf M, Nikolaou K, Stenzl A, Bedke J et al (2022) Robotic transrectal computed tomographic ultrasound with artificial neural network analysis: first validation and comparison with MRI-guided biopsies and radical prostatectomy. Urol Int 106(1):90–96
Xie Y, Tokas T, Grabski B, Loch T (2018) Internal fusion: exact correlation of transrectal ultrasound images of the prostate by detailed landmarks over time for targeted biopsies or follow-up. World J Urol 36(5):693–698
Panebianco V, Barchetti F, Sciarra A, Ciardi A, Indino EL, Papalia R, Gallucci M, Tombolini V, Gentile V, Catalano C (2015) Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol 33(1):1–7
Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM (2015) Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA 313(4):390–397
Taneja SS (2017) Re: diagnostic accuracy of multi-parametric MRI and TRUS Biopsy in Prostate Cancer (PROMIS): a paired validating confirmatory study. J Urol 198(1):101–102
Herlemann A, Overland MR, Washington SL 3rd, Cowan JE, Westphalen AC, Carroll PR, Nguyen HG, Shinohara K, Cooperberg MR (2021) How often does magnetic resonance imaging detect prostate cancer missed by transrectal ultrasound? Eur Urol Focus 7(6):1268–1273
Kuru TH, Roethke MC, Seidenader J, Simpfendorfer T, Boxler S, Alammar K, Rieker P, Popeneciu VI, Roth W, Pahernik S et al (2013) Critical evaluation of magnetic resonance imaging targeted, transrectal ultrasound guided transperineal fusion biopsy for detection of prostate cancer. J Urol 190(4):1380–1386
Giannarini G, Crestani A, Rossanese M, Ficarra V (2017) Multiparametric magnetic resonance imaging targeted biopsy for early detection of prostate cancer: all that glitters is not gold! Eur Urol 71(6):904–906
Le JD, Tan N, Shkolyar E, Lu DY, Kwan L, Marks LS, Huang J, Margolis DJ, Raman SS, Reiter RE (2015) Multifocality and prostate cancer detection by multiparametric magnetic resonance imaging: correlation with whole-mount histopathology. Eur Urol 67(3):569–576
Calio BP, Sidana A, Sugano D, Gaur S, Maruf M, Jain AL, Merino MJ, Choyke PL, Wood BJ, Pinto PA et al (2018) Risk of upgrading from prostate biopsy to radical prostatectomy pathology-does saturation biopsy of index lesion during multiparametric magnetic resonance imaging-transrectal ultrasound fusion biopsy help? J Urol 199(4):976–982
Acknowledgements
The authors would like to thank Prof. Luo Jun (Department of Urology, James Buchanan Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA.) for his help in manuscript revising and Prof. Yi Shen (Department of Epidemiology and Health Statistics, College of Public Health, Zhejiang University, Hangzhou, Zhejiang, China) for his help in Statistical analysis.
Author information
Authors and Affiliations
Contributions
LPX contributed to protocol development. JJX, YF, XYZ, GBW, WZZ, and HTC collected data. JFL, XYM, BL, and HC performed data analysis. XW wrote the manuscript. YQX edited the manuscript.
Corresponding author
Ethics declarations
Conflict of interest
None.
Ethical approval
This study was approved by Ethics Committee of participant hospitals and registered on ISRCTN (ISRCTN18033113).
Informed consent
This trial was performed in accordance to the Declaration of Helsinki. Written informed consent was provided for each participant.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Wang, X., Xie, Y., Zheng, X. et al. A prospective multi-center randomized comparative trial evaluating outcomes of transrectal ultrasound (TRUS)-guided 12-core systematic biopsy, mpMRI-targeted 12-core biopsy, and artificial intelligence ultrasound of prostate (AIUSP) 6-core targeted biopsy for prostate cancer diagnosis. World J Urol 41, 653–662 (2023). https://doi.org/10.1007/s00345-022-04086-0
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00345-022-04086-0