Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Prostate Cancer Detection Rate Assessed by Histopathological Examination
研究概览
简要总结
The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure. The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.
详细描述
This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng/mL).
All eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.
Participants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.
The study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology [ISUP] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.
No results are reported in this section. Study outcomes will be entered in the results section after study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-naïve patients
- •Prostate-specific antigen level between 4 and 20 ng/mL
- •Multiparametric Magnetic Resonance Imaging Prostate Imaging-Reporting and Data System score 4 or 5
排除标准
- •Prior prostate biopsy
- •Prostate-specific Antigen level outside the specified range
- •Contraindication to Magnetic Resonance Imaging
研究组 & 干预措施
Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session. Each participant will receive both biopsy techniques sequentially, allowing within-subject comparison. Participants will be assigned to one of two surgeons using a blinded randomization process; however, all participants will receive the same intervention protocol.
干预措施: Cognitive-targeted prostate biopsy (Procedure)
结局指标
主要结局
Prostate Cancer Detection Rate Assessed by Histopathological Examination
时间窗: During the biopsy session
Detection of prostate cancer based on histopathological examination of biopsy core specimens obtained using cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is reported as the presence or absence of prostate cancer and is not reported as a numerical score on a scale.
Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group
时间窗: During the biopsy session
Detection of clinically significant prostate cancer based on histopathological evaluation of biopsy specimens obtained using each biopsy technique. Clinically significant prostate cancer is defined using the International Society of Urological Pathology (ISUP) Grade Group classification, which ranges from Grade Group 1 (least aggressive) to Grade Group 5 (most aggressive). Clinically significant disease is defined as ISUP Grade Group 2 or higher. Higher ISUP grade groups indicate a worse pathological outcome.
次要结局
- Biopsy Procedure Time Measured in Minutes(During the procedure)
- Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging(Before the biopsy procedure)
- Procedural Metrics According to Surgeon Assignment(During the biopsy procedure)
研究者
Mahmoud Ahmed Mohammed
ASSISTANT LECTURER
Menoufia University