Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The clinically significant prostate cancer (csPCa) detection rate
研究概览
简要总结
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB).
The main questions it aims to answer are:
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive 3TB+6SB or 3TB+12SB.
详细描述
Currently, combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the 3TB+12SB 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 reduced when the chance of missing a clinically significant lesion is low. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Some retrospective studies have proved that the cancer detection rate of targeted biopsy plus sextant biopsy (3TB+6SB) was not inferior to 3TB+12SB. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the 3TB+6SB schemes. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy and safety of 3TB+6SB schemes and the routine 3TB+12SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of 3TB+6SB in improving the safety of prostate biopsy? This prospective RCT compared the csPCa detection rates of 3TB+6SB and 3TB+12SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from September 2024 to February 2025. Participants were randomly allocated to 3TB+6SB group and 3TB+12SB group.
Researchers will compare the cancer detection rates of 3TB+6SB and 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
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
- Single (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 85 years.
- •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
3TB+6SB group
For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB.
干预措施: 3TB+6SB (Procedure)
3TB+12SB group
For patients in the 3TB+12SB group, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB.
干预措施: 3TB+12SB (Procedure)
结局指标
主要结局
The clinically significant prostate cancer (csPCa) detection rate
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 week and one month after the biopsy procedure.)
- The operation time of prostate biopsy(During the prostate 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 self-reported quality of life after the prostate biopsy(One week and one month after the biopsy procedure.)
- The Gleason score (GS) of the biopsy sample(One month after the biopsy procedure.)
- The GS of radical prostatectomy (RP) specimens(One month after the biopsy procedure.)
研究者
LIU Yi
Associate chief physician
Peking University First Hospital