MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
The purpose of the study is to combine and correlate data from morphological and functional MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.
详细描述
A prospective study including 180 consecutive patients with PCa referred to Oslo University Hospital, Radiumhospitalet, for surgical treatment. In vivo functional MRI examination will be performed within a few days prior to robot-assisted radical prostatectomy (RALP). For a subgroup of patients FACBC PET will also be acquired prior to prostatectomy. A subgroup of intermediate and high-risk patients (D'Amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (Hypoxyprobe™-1)*. During surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. High-risk patients will undergo intraoperative lymph node dissection. Tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. Prostate specimen and regional lymph nodes will be histopathologically examined for T- and N-classification, Gleason grade, presence of micrometastasis and areas of hypoxia. Histological and molecular findings will be correlated to MRI and PET findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death).
*From 2013 oral administration is used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for surgery with confirmed prostate cancer, Gleason grade ≥ 3
- •Patient has received no prior treatment for prostate cancer.
- •Patient has adequate renal function: Estimated creatinine clearance ≥ 60 ml/minute.
- •Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee.
排除标准
- •Patient with contraindication to MR or MR contrast media according to clinical practice.
- •Patients who want to withdraw for any reason during the study.
- •Patients previously undergone pelvic surgery or radiation therapy
结局指标
主要结局
Death
时间窗: 2030
次要结局
未报告次要终点
研究者
Therese Seierstad
Head of Research, Department of Radiology and Nuclear Medicine
Oslo University Hospital
