Comparison of Regional Saturation Biopsy, Targeted Biopsy, and Systematic Biopsy in Patients with Prostate-specific Antigen Levels of 4-20 ng/ml: A Prospective, Single-center, Randomized Controlled Trial

Xingkang Jiang; Mingzhe Chen; Jing Tian; Xiaohua Li; Ranlu Liu; Yong Wang; Yang Zhao; Shuanghe Peng; Yuanjie Niu; Yong Xu

doi:10.1016/j.euo.2023.12.002

Comparison of Regional Saturation Biopsy, Targeted Biopsy, and Systematic Biopsy in Patients with Prostate-specific Antigen Levels of 4-20 ng/ml: A Prospective, Single-center, Randomized Controlled Trial

Eur Urol Oncol. 2023 Dec 28:S2588-9311(23)00283-3. doi: 10.1016/j.euo.2023.12.002. Online ahead of print.

Authors

Xingkang Jiang¹, Mingzhe Chen², Jing Tian², Xiaohua Li³, Ranlu Liu², Yong Wang², Yang Zhao⁴, Shuanghe Peng⁵, Yuanjie Niu⁶, Yong Xu⁷

Affiliations

¹ Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: jiangx@tmu.edu.cn.
² Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China.
³ Department of Pharmaceutical Clinical Trial, Second Hospital of Tianjin Medical University, Tianjin, China.
⁴ Department of Radiology, Second Hospital of Tianjin Medical University, Tianjin, China.
⁵ Department of Pathology, Second Hospital of Tianjin Medical University, Tianjin, China.
⁶ Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: niuyuanjie@gmail.com.
⁷ Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China. Electronic address: xuyong8816@sina.com.

PMID: 38158249
DOI: 10.1016/j.euo.2023.12.002

Abstract

Background: Despite the use of multiparametric magnetic resonance imaging (mpMRI)-guided targeted biopsy (TB) to identify suspicious prostate lesions, it may still miss clinically significant prostate cancer (csPCa) or result in false-negative findings. Recent evidence suggests that combining biopsies taken from within and around magnetic resonance imaging (MRI) lesions can improve the detection of csPCa.

Objective: This study aimed to compare the diagnostic performance of the regional saturation biopsy (RSB) method, involving template-based nine-core biopsies for suspected regions, with that of the MRI-directed TB and/or the systematic biopsy (SB) methods in biopsy-naïve patients with prostate-specific antigen (PSA) levels ranging from 4 to 20 ng/ml.

Design, setting, and participants: A prospective, single-center, randomized controlled trial included 434 biopsy-naïve patients with suspected lesions on mpMRI and PSA levels between 4 and 20 ng/ml (from January 2022 to July 2023).

Outcome measurements and statistical analysis: The detection rates of csPCa for the RSB, TB, and SB methods were analyzed using the McNemar test for intrapatient comparisons. The Fisher's exact test was used for comparisons between RSB and TB.

Results and limitations: The RSB approach yielded a significantly higher detection rate of csPCa than both the TB approach (44.1% vs 31.8%, p = 0.01) and the SB approach (44.1% vs 34.1%, p = 0.03). The RSB approach exhibited a comparable detection rate of csPCa (44.1% vs. 40.7%, p = 0.3) to the combined approach (TB + SB), while requiring fewer biopsy cores and a higher positive core number to avoid sampling the entire prostate gland (32.7% vs 18.3%, p < 0.001). Upon conducting a whole-mount histopathological analysis, it was observed that the RSB approach successfully identified 97% (32 out of 33) of the prostate cancer foci as the index lesion, whereas only 59.18% (29 out of 49) were classified as index lesions using the SB approach. Furthermore, mpMRI underestimated the average diameter of histological tumor size by a median of 0.76 cm, highlighting the importance of an optimal biopsy area for the RSB procedure.

Conclusions: For patients with suspected lesions on mpMRI and PSA levels between 4 and 20 ng/ml, the RSB approach has shown improved detection of clinically significant prostate cancer, accurately identifying index lesions, and minimizing biopsy cores compared with the MRI-directed TB and SB approaches.

Patient summary: For patients with suspected lesions on multiparametric magnetic resonance imaging and prostate-specific antigen levels between 4 and 20 ng/ml, the regional saturation biopsy method provides enhanced detection of clinically significant prostate cancer, as well as precise identification of index lesions, surpassing both magnetic resonance imaging-directed targeted biopsy and the systematic biopsy method.

Keywords: Clinically significant prostate cancer; Prostate biopsy; Prostatic neoplasms; Regional saturation biopsy; Systematic biopsy; Targeted biopsy.