The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA): a Prospective, Paired Diagnostic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy
研究概览
简要总结
Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. Indeed, several studies have shown that PSMA PET/CT outperformed choline PET/CT with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low PSA level. Moreover, the proPSMA trial reported that PSMA PET/CT had 27% greater accuracy than that of CT and bone scanning when staging patients with high-risk localised prostate cancer. More recently, availability of integrated PET/MRI scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. It also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions.
In the light of current issues, the next question is whether PSMA PET imaging could add to the detection of prostate cancer. Several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic PSMA PET/CT . Recently, in the PRIMARY trial, 291 men received successively MRI, PSMA PET/CT and systematic ± MRI-targeted biopsies. Despite similar PPV between imaging methods, the main advantage of PSMA was in men with equivocal MRI. Indeed, they found that 90% of csPCa was identified by PSMA PET/CT in this subgroup and paved the way for further investigation. This finding was confirmed in the most recent systematic review and meta-analysis.
The aim of this prospective study is to evaluate the added-value of PSMA PET in detecting prostate cancer in patients who are candidates for biopsy with equivocal MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria for inclusion in the study:
- •Men ≥ 18 years of age
- •Multiparametric MRI within the previous 6 months
- •At least one lesion PI-RADS 3
- •Able to provide written informed consent
排除标准
- •Eligible subjects must not meet any of the exclusion criteria listed below:
- •Previous prostate cancer diagnostic on MRI-targeted biopsy
- •At least one lesion PI-RADS 4-5
- •Negative MRI (PI-RADS 1-2)
- •Previous treatment for prostate cancer 11
- •Contraindication to PSMA PET and/or MRI and/or prostate biopsy
- •Low quality of MRI defined by a PI-QUAL score of 1 or 2
- •Any medical condition that may interfere with the study procedures.
研究组 & 干预措施
Patients with at least one lesion PI-RADS 3
干预措施: PSMA PET (Diagnostic Test)
结局指标
主要结局
Percentage of patients with clinically significant prostate cancer detected by PSMA PET-targeted biopsy
时间窗: Baseline
次要结局
未报告次要终点