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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

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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).

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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

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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.

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Authors and Affiliations

  1. Department of Urology, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou, 310003, Zhejiang Province, China

    Xiao Wang, Xiangyi Zheng, Ben Liu, Hong Chen, Jiangfeng Li, Xueyou Ma & Liping Xie

  2. Department of Urology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

    Yanqi Xie

  3. Department of Ultrasonography, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

    Jianjian Xiang

  4. Department of Urology, Ningbo Yinzhou No.2 Hospital, Ningbo, China

    Guobin Weng, Weizhi Zhu & Gang Wang

  5. Department of Ultrasonography, Ningbo Yinzhou No.2 Hospital, Ningbo, China

    Ye Fang

  6. Department of Urology, Shulan Hospital, Hangzhou, China

    Hongtao Cheng

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  1. Xiao Wang
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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

Correspondence to Liping Xie.

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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.

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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

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  • DOI: https://doi.org/10.1007/s00345-022-04086-0

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