An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Sensitivity of FCH-PET-CT scan
研究概览
简要总结
The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI/CT of the abdomen & pelvis in detecting the increased incidence of metastasis (nodal/distant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM.
- •Over the age of 18
- •Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either:
- •At a new diagnosis
- •Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy
- •Patients on active surveillance with a PSA doubling time of 6 months or less
排除标准
- •Diagnosis of other malignancy (excluding basal cell cancer/squamous cell cancer of the skin) within five years of diagnosis
- •Known metastatic prostate cancer, both local and distant
- •Patients who have received any oncological treatment within the last six months
- •Patients on any investigational drug treatment
- •Patients on steroids
- •Known history of inflammatory/infective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease)
- •Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)
结局指标
主要结局
1. Sensitivity of FCH-PET-CT scan
时间窗: Within 12 months of the last FCH-PET-CT scan
To determine if the sensitivity of FCH-PET-CT is superior to combined conventional imaging (MRI (T2 and T1 weighted)/CT and bone scan) in detecting nodal and distant (outside the pelvis) metastases in BRCA1/2 germline mutation carriers with prostate cancer.
次要结局
- Impact of FCH-PET-CT findings(Within 12 months of the last FCH-PET-CT scan)
- 2. Outline the Specificity of the FCH-PET-CT scan(Within 12 months of the last FCH-PET-CT scan)
- Metastasis Incidence(Within 12 months of the last FCH-PET-CT scan)