Ploussard Guillaume, Barret Eric, Fiard Gaëlle, Lenfant Louis, Malavaud Bernard, Giannarini Gianluca, Almeras Christophe, Aziza Richard, Renard-Penna Raphaële, Descotes Jean-Luc, Rozet François, Beauval Jean-Baptiste, Salin Ambroise, Rouprêt Morgan
La Croix du Sud Hospital, Quint-Fonsegrives, France.
Institut Mutualiste Montsouris, Paris, France.
Eur Urol Oncol. 2024 Oct;7(5):1080-1087. doi: 10.1016/j.euo.2024.01.019. Epub 2024 Feb 24.
Recent guidelines favor transperineal (TP) prostate biopsies over the transrectal (TR) approach due to a reduced sepsis risk. Yet, evidence from controlled trial comparing both approaches within the MRI-targeted pathway for significant prostate cancer (PCa) detection is lacking.
To compare the significant PCa detection rate between magnetic resonance imaging (MRI)-targeted TR and TP approaches in biopsy-naïve patients.
DESIGN, SETTING, AND PARTICIPANTS: In this noninferiority controlled trial, we randomized (ratio 1:1) 270 MRI-positive biopsy-naïve patients.
MRI-targeted TP versus TR biopsy.
The primary outcome was the detection rate of significant PCa (International Society of Urological Pathology [ISUP] ≥2) in MRI-targeted biopsies. Secondary outcomes were any-grade PCa detection, detection on concomitant systematic biopsy, complications, and functional outcomes.
Targeted biopsies identified significant PCa in 47.2% of TP and 54.2% of TR participants (-7%, p = 0.6235). On a per-lesion analysis, posterior lesions yielded higher detection rates via TR (59.0% vs 44.3%, p = 0.0443), while anterior lesions were more frequently detected via TP (40.6% vs 26.5%, p = 0.2228). The overall (any grade) cancer detection rate in targeted biopsies was comparable between groups: 71.3% (TP) versus 64.1% (TR; p = 0.2209) with significantly more ISUP 1 cases detected in the TP arm. Adverse events of grade ≥2 were not different between TP (35.7%) and TR (40.5%, p = 0.4256). One TR patient (0.8%) experienced grade 3 sepsis. Quality of life, and urinary and sexual function, as well as pain scores, were comparable between groups.
Despite a comparable overall detection rate for any-grade PCa, noninferiority of TP over TR for MRI-targeted biopsies for significant PCa detection was not demonstrated. However, MRI lesion location influenced biopsy route performance, suggesting that a pragmatic approach based on lesion location might enhance significant PCa assessment.
This trial compared the efficacy and safety of two biopsy approaches for prostate cancer diagnosis. Both approaches seem complementary according to the lesion location.
由于败血症风险降低，近期指南更倾向于经会阴（TP）前列腺活检而非经直肠（TR）途径。然而，缺乏在磁共振成像（MRI）引导下检测前列腺癌（PCa）的途径中比较这两种方法的对照试验证据。
比较MRI引导下TR和TP途径在初诊患者中检测显著PCa的比率。
设计、场所和参与者：在这项非劣效性对照试验中，我们将270例MRI阳性初诊患者随机分组（比例1:1）。
MRI引导下的TP与TR活检。
主要结果是MRI引导下活检中显著PCa（国际泌尿病理学会[ISUP]≥2）的检测率。次要结果是任何分级的PCa检测、同时进行的系统活检中的检测、并发症和功能结果。
靶向活检在47.2%的TP组参与者和54.2%的TR组参与者中发现了显著PCa（-7%，p = 0.6235）。在每病灶分析中，TR途径对后部病灶的检测率更高（59.0%对44.3%，p = 0.0443），而TP途径对前部病灶的检测更频繁（40.6%对26.5%，p = 0.2228）。靶向活检中的总体（任何分级）癌症检测率在两组之间相当：71.3%（TP）对64.1%（TR；p = 0.2209），TP组中检测到的ISUP 1级病例明显更多。TP组（35.7%）和TR组（40.5%，p = 0.4256）中≥2级不良事件无差异。1例TR组患者（0.8%）发生3级败血症。两组之间的生活质量、泌尿和性功能以及疼痛评分相当。
尽管任何分级PCa的总体检测率相当，但未证明在MRI引导下活检检测显著PCa时TP相对于TR具有非劣效性。然而，MRI病灶位置影响活检途径的表现，这表明基于病灶位置的实用方法可能会提高对显著PCa的评估。
本试验比较了两种前列腺癌活检方法的疗效和安全性。根据病灶位置，两种方法似乎具有互补性。
