KCT0009488招募中Unknown
Clinical efficacy of pre-operative [F-18] Florastamin PSMA PET/CT in men with intermediate- or high-risk localized prostate cancer who undergo radical prostatectomy: Prospective single-arm clinical trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- Male
入选标准
- •Male patients aged 19 to 80 years
- •Patients diagnosed with histopathologically confirmed prostate cancer
- •Intermediate or high-risk prostate cancer according to the D'Amico classification
- •Adequate functional status to carry out normal daily activities (Eastern Cooperative Oncology Group performance status of 0 or 1)
- •Patients capable of understanding and voluntarily consenting to the contents of the informed consent form
排除标准
- •Patients suspected of pelvic distant metastases based on imaging or tissue examination
- •Patients with prior pelvic radiotherapy
- •Patients who have received hormone therapy, neoadjuvant chemotherapy, or radiotherapy for prostate cancer
- •Patients with reported allergies to substances used in previous PET/CT or MRI scans or research
- •Life expectancy of less than 5 years
- •Uncontrolled infectious diseases (persistent sepsis with fever despite treatment)
- •Mental disorders (schizophrenia, bipolar disorder, intellectual disability)
- •Patients with moderate to severe cardiovascular, cerebrovascular, respiratory, or hepatic diseases or other comorbidities that render them unsuitable for clinical trial participation
- •Patients diagnosed with another type of cancer within 2 years (excluding non-metastatic skin basal cell or cutaneous superficial squamous cell carcinoma (T1-3N0M0) or superficial bladder cancer)
- •Patients with pelvic metal implants affecting the quality of PET/CT images
- •Other patients deemed unsuitable for participation in the clinical trial according to investigator discretion
- •Claustrophobia
- •Patients who have undergone Ga-68 PSMA-11 PET-CT before treatment
研究者
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