PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen Radioligands on Newly Diagnosed Prostate Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Evaluation of aggressiveness of prostate cancer.
研究概览
简要总结
The primary aim of this large prospective study consists of exploring the correlation among Volumetric and Radiomic parameters extracted from staging PSMA PET/CT Imaging versus conventional baseline clinical biochemical data, conventional imaging and the aggressiveness of the tumor based on the post-surgical-Gleason Score (GS) in patients with intermediate/high risk prostate cancer (PCa).
Secondarily, Volumetric and Radiomic features extracted from the same PET images will be compared with the amount of the Circulating Tumor Cells (CTCs), with the expression of specific receptors on CTCs surface,
Possible mutations encoding androgen receptors (AR) on CTCs surface, and with PSMA density on primary tumor cells provided by the Immunohistochemistry method (IHC) applied on post-surgical histological samples.
According to PET images, Volumes of interest (VOI) encompassing the whole prostate with foci of PSMA uptake suspected for PCa will be drawn to extract semiquantitative and radiomic PET features.
The association between PSMA PET radiomics and CTCs molecular and genomic panel at staging could potentially lead to a more personalized and more effective therapeutic chances.
详细描述
The following clinical conventional parameters will be collected :
- age (years),
- results of DRE, digital rectal examination (positivie or negative)
- Prostate-Specific Antigen. PSA levels (ng/ml)
- conventional PET parameters and ,(tSUVmax, tSUVmean, tMTV, tTLA),
- first-order radiomic features (tSkewness, tKurtosis)
- results from mpMRI (PIRADS categories from 1 to 5 according to v2.1)
- biopsy-based Gleason Score, GS (referrred to WHO/ISUP score)
- the amount of circulating tumor cells by the bloodstream peripheral samples CTCs (cells number/ml of blood volume)
- the overexpression of specific receptors on the CTCs surface, such as the epidermal grow factor receptor (EGFR), PSMA receptor.
- percentage of expression of specific receptors and their potential mutations on CTCs surface, in terms of percentage of expression of PSMA and GRPR based on histological post-surgical specimen on tumor cell surface.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to sign informed consent
- •Biopsy-confirmed intermediate/high risk prostate cancer
- •Good compliance to undergo mpMRI scan and PET/CT scan
- •Eligible for radical prostatectomy
排除标准
- •Contraindication to mpMRI (such. Metal implants and/or pacemaker)
- •Poor compliance to undergo PET/CT (i.e.claustrophobia)
结局指标
主要结局
Evaluation of aggressiveness of prostate cancer.
时间窗: 9 months
Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features
次要结局
- Radiogenomic panel of prostate cancer.(9 months)