Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naïve Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial.
무작위 임상시험
2/5 보강
TL;DR
For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme.
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
환자: visible suspicious lesions on MRI in recent years
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSIONS] For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme. [TRIAL REGISTRATION] ClinicalTrials.gov Identifier: NCT06482658.
OpenAlex 토픽 ·
Prostate Cancer Diagnosis and Treatment
Prostate Cancer Treatment and Research
Urinary Bladder and Prostate Research
For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme.
- 표본수 (n) 190
- 연구 설계 randomized controlled trial
APA
Ruiyi Deng, Derun Li, et al. (2026). Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naïve Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial.. The Journal of urology, 215(4), 408-420. https://doi.org/10.1097/JU.0000000000004863
MLA
Ruiyi Deng, et al.. "Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naïve Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial.." The Journal of urology, vol. 215, no. 4, 2026, pp. 408-420.
PMID
41270377 ↗
Abstract 한글 요약
[PURPOSE] The combined targeted and systematic biopsy (CTSBx) was the standard scheme for patients with visible suspicious lesions on MRI in recent years. 2024 European Association of Urology guideline recommended targeted and perilesional biopsy (TPLBx) for the diagnosis of patients with MRI-visible suspicious lesions. This randomized controlled trial aims to comprehensively evaluate the efficacy and safety profiles of TPLBx and CTSBx schemes.
[MATERIALS AND METHODS] A single-center noninferiority randomized controlled trial consecutively enrolled 380 biopsy-naïve patients (CTSBx: n = 190, TPLBx: n = 190) with a single unilateral suspicious lesion on prostate MRI from June 2024 to November 2024. The noninferiority margin was -15%. All biopsies were undertaken transrectally through the cognitive fusion technique. The primary outcome was Grade Group (GG) ≥ 2 cancer (GG ≥ 2-PCa) detection rate.
[RESULTS] The GG ≥ 2-PCa (58% vs 58%, risk difference [RD]: 0.53% [95% CI: -9.4% to 11%]) and GG ≥ 3-PCa (30% vs 30%, RD: 0.53% [95% CI: -8.7% to 9.7%]) detection rates of TPLBx were noninferior to that of CTSBx ( < .001). There was no significant difference in PCa and GG1-PCa detection rates between the 2 groups ( > .050). The complication rate of TPLBx was significantly lower than that of CTSBx group (Clavien-Dindo scale ≥ 1: 62% vs 74%, = .023), especially for bleeding-related complications (rectal bleeding: 34% vs 48%, = .003; hematuria, 39% vs 56%, < .001) and rectal pain (25% vs 34%, = .018). TPLBx could significantly shorten the procedure time and saved the pathological cost ( < .001).
[CONCLUSIONS] For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme.
[TRIAL REGISTRATION] ClinicalTrials.gov Identifier: NCT06482658.
[MATERIALS AND METHODS] A single-center noninferiority randomized controlled trial consecutively enrolled 380 biopsy-naïve patients (CTSBx: n = 190, TPLBx: n = 190) with a single unilateral suspicious lesion on prostate MRI from June 2024 to November 2024. The noninferiority margin was -15%. All biopsies were undertaken transrectally through the cognitive fusion technique. The primary outcome was Grade Group (GG) ≥ 2 cancer (GG ≥ 2-PCa) detection rate.
[RESULTS] The GG ≥ 2-PCa (58% vs 58%, risk difference [RD]: 0.53% [95% CI: -9.4% to 11%]) and GG ≥ 3-PCa (30% vs 30%, RD: 0.53% [95% CI: -8.7% to 9.7%]) detection rates of TPLBx were noninferior to that of CTSBx ( < .001). There was no significant difference in PCa and GG1-PCa detection rates between the 2 groups ( > .050). The complication rate of TPLBx was significantly lower than that of CTSBx group (Clavien-Dindo scale ≥ 1: 62% vs 74%, = .023), especially for bleeding-related complications (rectal bleeding: 34% vs 48%, = .003; hematuria, 39% vs 56%, < .001) and rectal pain (25% vs 34%, = .018). TPLBx could significantly shorten the procedure time and saved the pathological cost ( < .001).
[CONCLUSIONS] For patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the noninferior diagnostic efficacy of clinically significant PCa and better safety than the CTSBx scheme.
[TRIAL REGISTRATION] ClinicalTrials.gov Identifier: NCT06482658.
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