18F Prostate Specific Membrane Antigen (PSMA) PET/CT-MRI fusion evaluation of high grade multi-parametric MRI abnormalities in patients with suspected prostate cancer.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
Almost 86% of PI-RADS 4 lesion(s) and PI-RADS 5 lesion(s) at least 10mm, on mpMRI prostate were PSMA avid. 20.3% of PI-RADS 4 lesion(s) at least 10mm or PI-RADS 5 lesion(s) confirmed to have high grade prostate cancer (GG 4 or 5) on biopsy. SUV Max at 60, 90 and 120 minutes were recorded and analysed. There was a statistically significant small average systematic increase in SUV from 60 to 120 minutes. Univariate regression analysis was performed to measure the affect of age, volume of prostate, size of lesion, PSA, PSA density and Grade group of lesion, if any, on the difference in SUV at each time point. On comparison between 60 and 90 minutes, volume of prostate was found to be statistically significant whereas between 60 and 120 minutes, GG of lesion was found to be statistically significant. 58% of men proceeded to radical prostatectomy out of which 17% were upgraded on histopathology, 8% were downgraded and 71% remained the same grade group of identified lesions on mpMRI and PSMA PET/MRI fusion and biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Men greater than or equal to 50 years old
- •Elevated PSA, more than 3.0ng/mL on 2 or more occasions with no other cause identified or an abnormal Digital Rectal Examination (DRE) that remains organ confined, i.e. cT2
- •No previously diagnosed PCa
- •No previous prostate biopsies
- •Undergoing mpMRI and considering prostate biopsy
- •Ability to give written informed consent, participate in and comply with study
排除标准
- •Previous diagnosis of PCa
- •Previous prostate biopsies
- •Inability/ incapacity to provide own consent
- •PSA more than 20ng/ml
- •more than or equal to cT3 on DRE
- •Previous TURP
- •Contraindication to MRI, including but not restricted to:
- •oPacemaker or other electronic implant
- •oAllergy or contraindication to MRI contrast, e.g. renal failure (eGFR less than 30mL/min)
- •oShrapnel, tattoos, non-removable body piercings (relative contraindication)