Efficacy and Safety Evaluation of Transrectal Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- The clinically significant prostate cancer (csPCa) detection rate for PB/RSB and TB+SB
研究概览
简要总结
The goal of this single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does transrectal PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of transrectal prostate biopsy? Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of TB+SB to explore the efficacy of different transrectal prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive transrectal PB/RSB or TB+SB.
详细描述
Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.
Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The age of the patient is between 45 and
- •No previous biopsy,
- •Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥
- •Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.
- •The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
- •Patients with complete clinical information.
排除标准
- •The mpMRI data was unqualified or incomplete.
- •Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
- •Patients with previous biopsy.
- •Patients with PI-RADS V2.1 of <
- •Patients were not in accordance with the indication of prostate biopsy.
- •The patient could not cooperate to complete the prostate biopsy.
- •The patients or their family members refused to participate in this study.
- •Patients with incomplete clinical information.
研究组 & 干预措施
Transrectal perilesional/regional systematic biopsy (PB/RSB) group
For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion.
干预措施: Transrectal perilesional/regional systematic biopsy (PB/RSB) (Procedure)
Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group
For patients in the TB+SB group, three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy.
干预措施: Combination of transrectal systematic biopsy and targeted biopsy (Procedure)
结局指标
主要结局
The clinically significant prostate cancer (csPCa) detection rate for PB/RSB and TB+SB
时间窗: One month after the biopsy procedure.
csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result.
次要结局
- The overall complication rate(One month after the biopsy procedure.)
- The operation time of prostate biopsy(During the prostate biopsy procedure.)
- The self-reported quality of life after the prostate biopsy(One month after the biopsy procedure.)
- The PCa detection rate(One month after the biopsy procedure.)
- The clinically insignificant PCa detection rate(One month after the biopsy procedure.)
- The Gleason score (GS) of the biopsy sample(One month after the biopsy procedure.)
- The Gleason score (GS) of radical prostatectomy (RP) specimens(One month after the biopsy procedure.)
研究者
LIU Yi
Associate chief physician
Peking University First Hospital