Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy

Biming He, Rongbing Li, Dongyang Li, Liqun Huang, Xiaofei Wen, Guosheng Yang, Haifeng Wang, Biming He, Rongbing Li, Dongyang Li, Liqun Huang, Xiaofei Wen, Guosheng Yang, Haifeng Wang

Abstract

Introduction: The classical pathway for diagnosing prostate cancer is systematic 12-core biopsy under the guidance of transrectal ultrasound, which tends to underdiagnose the clinically significant tumour and overdiagnose the insignificant disease. Another pathway named targeted biopsy is using multiparametric MRI to localise the tumour precisely and then obtain the samples from the suspicious lesions. Targeted biopsy, which is mainly divided into cognitive fusion method and software-based fusion method, is getting prevalent for its good performance in detecting significant cancer. However, the preferred targeted biopsy technique in detecting clinically significant prostate cancer between cognitive fusion and software-based fusion is still beyond consensus.

Methods and analysis: This trial is a prospective, single-centre, randomised controlled and non-inferiority study in which all men suspicious to have clinically significant prostate cancer are included. This study aims to determine whether a novel three-dimensional matrix positioning cognitive fusion-targeted biopsy is non-inferior to software-based fusion-targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy. The main inclusion criteria are men with elevated serum prostate-specific antigen above 4-20 ng/mL or with an abnormal digital rectal examination and have never had a biopsy before. A sample size of 602 participants allowing for a 10% loss will be recruited. All patients will undergo a multiparametric MRI examination, and those who fail to be found with a suspicious lesion, with the anticipation of half of the total number, will be dropped. The remaining participants will be randomly allocated to cognitive fusion-targeted biopsy (n=137) and software-based fusion-targeted biopsy (n=137). The primary outcome is the detection rate of clinically significant prostate cancer for cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy in men without a prior biopsy. The clinically significant prostate cancer will be defined as the International Society of Urological Pathology grade group 2 or higher.

Ethics and dissemination: Ethical approval was obtained from the ethics committee of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. The results of the study will be disseminated and published in international peer-reviewed journals.

Trial registration number: ClinicalTrials.gov Registry (NCT04271527).

Keywords: oncology; prostate disease; urology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial flow chart. mpMRI, multiparametric MRI; PI-RADS, Prostate Imaging-Reporting and Data System.
Figure 2
Figure 2
Twenty-region template-guided prostate biopsy.

References

    1. Bray F, Ferlay J, Soerjomataram I, et al. . Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394–424. 10.3322/caac.21492
    1. Caverly TJ, Hayward RA, Reamer E, et al. . Presentation of benefits and harms in US cancer screening and prevention guidelines: systematic review. J Natl Cancer Inst 2016;108:djv436. 10.1093/jnci/djv436
    1. Abraham NE, Mendhiratta N, Taneja SS. Patterns of repeat prostate biopsy in contemporary clinical practice. J Urol 2015;193:1178–84. 10.1016/j.juro.2014.10.084
    1. Ahmed HU, El-Shater Bosaily A, Brown LC, et al. . Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017;389:815. 10.1016/S0140-6736(16)32401-1
    1. Kasivisvanathan V, Rannikko AS, Borghi M, et al. . MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 2018;378:1767–77. 10.1056/NEJMoa1801993
    1. Tyson MD, Arora SS, Scarpato KR, et al. . Magnetic resonance-ultrasound fusion prostate biopsy in the diagnosis of prostate cancer. Urol Oncol 2016;34:326. 10.1016/j.urolonc.2016.03.005
    1. Siddiqui MM, Rais-Bahrami S, Turkbey B, et al. . Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA 2015;313:390. 10.1001/jama.2014.17942
    1. Sonn GA, Natarajan S, Margolis DJA, et al. . Targeted biopsy in the detection of prostate cancer using an office based magnetic resonance ultrasound fusion device. J Urol 2013;189:86. 10.1016/j.juro.2012.08.095
    1. Puech P, Rouvière O, Renard-Penna R, et al. . Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology 2013;268:461–9. 10.1148/radiol.13121501
    1. Marra G, Ploussard G, Futterer J, et al. . Controversies in Mr targeted biopsy: alone or combined, cognitive versus software-based fusion, transrectal versus transperineal approach? World J Urol 2019;37:277. 10.1007/s00345-018-02622-5
    1. Wegelin O, Exterkate L, van der Leest M, et al. . 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 2019;75:582–90. 10.1016/j.eururo.2018.11.040
    1. Wysock JS, Rosenkrantz AB, Huang WC, et al. . A prospective, blinded comparison of magnetic resonance (Mr) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol 2014;66:343. 10.1016/j.eururo.2013.10.048
    1. Kaufmann S, Russo GI, Bamberg F, et al. . Prostate cancer detection in patients with prior negative biopsy undergoing cognitive-, robotic- or in-bore MRI target biopsy. World J Urol 2018;36:761–8. 10.1007/s00345-018-2189-7
    1. Wang H-F, Chen R, He B-M, et al. . Initial experience with a novel method for cognitive transperineal magnetic resonance imaging-targeted prostate biopsy. Asian J Androl 2020;22:432–6. 10.4103/aja.aja_83_19
    1. Epstein JI, Egevad L, Amin MB, et al. . 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;40:244–52. 10.1097/PAS.0000000000000530
    1. Turkbey B, Rosenkrantz AB, Haider MA, 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;76:340. 10.1016/j.eururo.2019.02.033
    1. He B-M, Chen R, Shi Z-K. Trans-perineal template-guided mapping biopsy vs. freehand trans-perineal biopsy in Chinese patients with PSA. Front Oncol 2019;9:758. 10.3389/fonc.2019.00758
    1. He B-M, Shi Z-K, Li H-S, et al. . A novel prediction tool based on multiparametric magnetic resonance imaging to determine the biopsy strategy for clinically significant prostate cancer in patients with PSA levels less than 50 ng/ml. Ann Surg Oncol 2020;27:1284. 10.1245/s10434-019-08111-2
    1. Hofbauer SL, Maxeiner A, Kittner B, et al. . Validation of prostate imaging reporting and data system version 2 for the detection of prostate cancer. J Urol 2018;200:767. 10.1016/j.juro.2018.05.003

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe