| Background:Prostate biopsy guided by ultrasound CT with artificial intelligence(AI-US-CT)has not been compared with TRUS-guided 12-core systematic biopsy(systematic group)or mpMRI assisted 12-core systematic biopsy(mpMRI group)in a randomized controlled trial(RCT).Objective:To compare the prostate cancer detection rate in AI-US-CT group against systematic group and mpMRI group.Methods:This RCT included 328 patients with suspicious for prostate cancer,randomized to AI-US-CT group,systematic group,and mpMRI group between January 2015 and December 2017.1n AI-US-CT group,AI-US-CT guided 6-core biopsy was performed.In mpMRI group,mpMRI suspicious lesions were targeted by 2-core TRUS guided biopsy,followed by 10-core systematic biopsy.Otherwise,12-core systematic biopsy was performed.The detection rate of prostate cancer,positivity rate for biopsy cores,number of biopsy cores needed to detect one prostate cancer □ were compared in AI-US-CT group against systematic group and mpMRI group.In mpMRI group,the detection rate of prostate cancer was compared with AI-US-CT group by each PI-RADS category.Results:Detection rate for prostate cancer in AI-US-CT group(56/113,49.6%)significantly differ from systematic group(36/106,34.0%,p = 0.021)or mpMRI group(39/109,35.8%;p = 0.043).The number of targeted biopsy cores and positivity rate for biopsy cores in AI-US-CT group significantly differed from systematic group and mpMRI group(p<0.001).AI-US-CT-targeted 6-core biopsy significantly improved prostate cancer detection rate compared to mpMRI assisted 12-core systematic biopsy especially when PI-RADS category were 2(9/43.20.9%,p = 0.001)and 3(10/34,29.4%,p = 0.049).The main limitation of our study is a potential overoptimistic power calculation,leading to an underpowered study.Conclusion:AI-US-CT-targeted 6-core biopsy has the highest detection rate of PCa compared to TRUS-guided 12-core systematic biopsy and mpMRI assisted 12-core systematic biopsy with less biopsy cores. |
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