Prostate Hyperfixation on PET-choline in Patients With Prostate Cancer: Correlation With MRI and Pathological Data
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
- Local diagnostic performances of PET-choline in prostate cancer
研究概览
简要总结
In France, when prostate cancer is suspected, multiparametric MRI is the reference imaging technique for tumor localization, and is used to guide biopsies in order to characterize the tumor as accurately as possible.
Under the hypothesis that 18 F-choline PET-CT is not inferior to MRI in localizing intra-prostate tumor foci, and could provide complementary data for biopsy, the localizing performance of these two imaging modalities is compared retrospectively, in patients with newly diagnosed prostate tumor treated by surgery.
详细描述
Prostate cancer is the most common cancer among men in France. Diagnosis is based on multiple biopsies, including targeted biopsies after multiparametric MRI. Improving the precision of these targeted biopsies would improve early detection and staging of the disease.
PET-choline has already proved its superiority over MRI in localizing tumor foci in certain indications, particularly in prostate cancer.
Under the hypothesis that 18 F-choline PET-CT is not inferior to multiparametric MRI for the detection and localization of intraprostatic tumor foci, and could provide additional data for biopsy guidance, the performance of these two examinations was calculated in comparison with the gold standard (prostatectomy specimen), and then compared with each other, in patients newly diagnosed with prostate cancer and treated by radical prostatectomy.
For this purpose, all patients treated at Brest University Hospital by radical prostatectomy for prostatic neoplasia, and who underwent preoperative mpMRI and PET-choline from January 1, 2015 to April 30, 2020, were retrospectively analyzed.
Data were collected from available electronic medical records, including variables such as age at diagnosis, time between PET-choline and prostate biopsies, and the various clinico-biological components of the d'Amico classification (clinical T stage, PSA at diagnosis, biopsy Gleason score).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent initial MRI for suspected prostatic neoplasia
- •Patients who have undergone a PET-choline scan as part of extension work-up.
- •Patients who have undergone radical prostatectomy for curative treatment.
- •Patients who have not expressed opposition to the use of data for clinical research purposes.
- •Patients affiliated to French Social Security system.
排除标准
- •Patient under legal protection
- •Patient's refusal to allow his data to be used for clinical research
结局指标
主要结局
Local diagnostic performances of PET-choline in prostate cancer
时间窗: 8 months
For each sextant (i.e. base, middle, apex, right and left), the presence or absence (rated 1 or 0) of asuspicious focus on PET-choline will be compared with the presence or absence of a tumour focus on gold-standard (prostatectomy specimen). The diagnostic performances (sensitivity, specificity, negative predictive value and positive predictive value) of PET-choline will be deduced.
次要结局
- Comparaison between IRM diagnostic performances and diagnostic PET-Choline performances(Through study completion, an average of 8 months)
- Local diagnostic performances of PET-choline in prostate cancer by subgroup(8 months)