Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions
研究概览
简要总结
In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.
详细描述
Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.
High-risk prostate cancer patients referred for radical prostatectomy.
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
- •Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
- •PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.
- •≥4 weeks since last biopsy of the prostate
- •One or more of the following criteria
- •cT3, or high suspicion of extra prostatic growth on mpMRI
- •Gleason score ≥8
- •PSA 20-49 ng/ml
- •Given a written consent to participate in the trial
排除标准
- •Non-MR-safe implants or another contraindication to MRI or PET
- •Claustrophobia
- •Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
- •Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
- •TUR-P within 6 months
- •Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
- •Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
- •Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
- •Tinnitus or severe hearing loss
研究组 & 干预措施
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
One-time pre-surgical imaging using [18F]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
干预措施: [18F]PSMA-PET (Drug)
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
One-time pre-surgical imaging using [18F]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
干预措施: MRI sequences optimized for prostate cancer examinations (Device)
结局指标
主要结局
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions
时间窗: Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology
Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.
次要结局
未报告次要终点