Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China.
Department of Urology, Second Hospital of Tianjin Medical University, Tianjin, China.
Eur Urol Oncol. 2024 Aug;7(4):944-953. doi: 10.1016/j.euo.2023.12.002. Epub 2023 Dec 28.
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.
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).
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.
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.
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.
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.
尽管使用多参数磁共振成像（mpMRI）引导的靶向活检（TB）来识别可疑的前列腺病变，但仍可能遗漏临床显著的前列腺癌（csPCa）或导致假阴性结果。最近的证据表明，结合 MRI 病变内外的活检可以提高 csPCa 的检出率。
本研究旨在比较区域饱和活检（RSB）方法与 MRI 引导的 TB 和/或系统活检（SB）方法在 PSA 水平为 4 至 20ng/ml 的活检初治患者中对可疑病变的诊断性能。
设计、地点和参与者：一项前瞻性、单中心、随机对照试验纳入了 434 名 mpMRI 上有可疑病变且 PSA 水平在 4 至 20ng/ml 之间的活检初治患者（2022 年 1 月至 2023 年 7 月）。
使用 McNemar 检验对内患者比较分析 RSB、TB 和 SB 方法的 csPCa 检出率。使用 Fisher 精确检验比较 RSB 和 TB。
RSB 方法的 csPCa 检出率明显高于 TB 方法（44.1%比 31.8%，p=0.01）和 SB 方法（44.1%比 34.1%，p=0.03）。RSB 方法与联合方法（TB+SB）的 csPCa 检出率相当（44.1%比 40.7%，p=0.3），但需要较少的活检核心数和更高的阳性核心数来避免对整个前列腺进行采样（32.7%比 18.3%，p<0.001）。进行全组织学分析后发现，RSB 方法成功将 97%（32 个中的 33 个）的前列腺癌病灶识别为索引病灶，而 SB 方法仅将 59.18%（49 个中的 29 个）识别为索引病灶。此外，mpMRI 低估了组织学肿瘤大小的平均直径中位数为 0.76cm，突出了 RSB 程序中最佳活检区域的重要性。
对于 mpMRI 上有可疑病变且 PSA 水平在 4 至 20ng/ml 之间的患者，与 MRI 引导的 TB 和 SB 方法相比，RSB 方法提高了临床显著前列腺癌的检出率，准确识别了指数病变，并减少了活检核心数量。
对于 mpMRI 上有可疑病变且 PSA 水平在 4 至 20ng/ml 之间的患者，区域饱和活检方法在检出临床显著前列腺癌、准确识别指数病变方面优于 MRI 引导的靶向活检和系统活检方法，可减少活检核心数量。
