Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Diagnostic Sensitivity
研究概览
简要总结
The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
详细描述
This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.
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
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Serum PSA > 4 ng/mL
- •At least one prior negative prostate biopsy
- •At least two consecutive increases in PSA and/or PHI
- •Negative digital rectal examination
- •Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
排除标准
- •Age ≤ 30 years or > 85 years
- •Concurrent presence of other malignant tumors
- •Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
- •Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
- •Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
- •Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
- •Incomplete clinical or pathological data
研究组 & 干预措施
The control group
The control group will receive TRUS guided transperineal saturation biopsy.
干预措施: TRUS guided transperineal saturation biopsy (Diagnostic Test)
The experimental group
The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed.
干预措施: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy (Diagnostic Test)
结局指标
主要结局
Diagnostic Sensitivity
时间窗: Perioperative
It refers to the percentage of patients who actually have prostate cancer correctly identified as positive (true positive). The calculation formula is: TP/(TP+FN)×100%. TP is true positive, and FN is false negative.
Diagnostic Specificity
时间窗: Perioperative
It refers to the percentage of patients who do not actually have prostate cancer correctly identified as negative (true negative). The calculation formula is: TN/(TN+FP)×100%. TN is true negative, and FP is false positive.
Positive Predictive Value(PPV)
时间窗: Perioperative
It refers to the proportion of true positives among the positive results obtained by a specific testing method. The calculation formula is: PPV = TP/(TP+FP)×100%.
Negative Predictive Value(NPV)
时间窗: Perioperative
It refers to the proportion of true negatives among the negative results obtained by a specific testing method. The calculation formula is: NPV = TN/(TN+FN)×100%.
Positive Likelihood Ratio(PLR)
时间窗: Perioperative
It refers to the ratio of the probability of correctly identifying a patient with prostate cancer as positive to the probability of incorrectly identifying a patient without prostate cancer as positive. The calculation formula is: +LR = Sensitivity / (1- Specificity)×100%.
Negative Likelihood Ratio(NLR)
时间窗: Perioperative
It refers to the ratio of the probability of incorrectly identifying a patient with prostate cancer as negative to the probability of correctly identifying a patient without prostate cancer as negative. The calculation formula is:-LR = (1- Sensitivity) / Specificity×100%.
Correct Diagnostic Index
时间窗: Perioperative
It refers to the sum of sensitivity and specificity minus 1. The correct diagnostic index can be used for comparing two diagnostic methods, with an ideal correct diagnostic index of 100%.r = (Specificity+Sensitivity) -1 = 1- (False Positive Rate + False Negative Rate).
次要结局
- PRECISION Questionnaire(1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.)
- EORTC QLQ-C30 Questionnaire(Before diagnosis, 1 month, 3 months, 6 months, 12 months)
- Generalized Anxiety Disorder GAD-7 Scale(Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months)
- Decision Conflict Scale, Decision Regret Scale(Before diagnosis, 1 month, 3 months, 6 months)
研究者
Ning Xu
Deputy Director of Department
First Affiliated Hospital of Fujian Medical University