Diagnostic Performance of 68Ga-PSMA PET/MRI in Suspicious Biopsy-naive Prostate Cancer Patients With Favorable Lesion on PET But Unfavorable on MRI for Primary Prostate Cancer Detection: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Detection rate of prostate cancer
研究概览
简要总结
This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
详细描述
Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.
It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.
This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
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
- •Men more than 18 years old with clinical suspicion of prostate cancer;
- •Serum prostate-specific antigen (PSA) > 4 ng/ml within the previous 3 months;
- •PI-RADS score no more than 3 or normal mpMRI of prostate;
- •Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
- •no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- •Able to provide written informed consent.
排除标准
- •Prior prostate biopsy or prostate surgery;
- •Prior treatment for prostate cancer;
- •Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- •Contraindication to prostate biopsy.
研究组 & 干预措施
Prostate biopsy with 68Ga-PSMA PET/MRI
Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI
干预措施: multiparametric MRI and 68Ga-PSMA PET/MRI (Device)
Prostate biopsy with 68Ga-PSMA PET/MRI
Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI
干预措施: Prostate biopsy (Procedure)
结局指标
主要结局
Detection rate of prostate cancer
时间窗: 30 days post biopsy
Detection rate of prostate cancer
次要结局
- Detection rates of clinically significant PCa and clinically insignificant prostate cancer(30 days post biopsy)
- Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology(90 days post biopsy)
- Optimal cut-off uptake value on PET/MRI for prostate cancer detection(30 days post-biopsy)
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School