ACTRN12621001185853已完成2 期
A prospective, multi-centre, single-arm diagnostic phase 2 open-label trial to assess additional diagnostic benefit of FDG PET/CT imaging after staging with PSMA PET for newly diagnosed high grade prostate cancer prior to treatment
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Men aged 18 years or older
- •2. Untreated, histologically confirmed prostate cancer
- •3. High risk disease according to clinical features, at least one of;
- •- Serum PSA >20ng/ml
- •- Biopsy Gleason Grade 4+4 or higher / Grade Group 4 or higher
- •- cT3/4 according to digital rectal examination (DRE) and/or magnetic resonance imaging (MRI)
- •4. Negative, Localised or metastatic disease according to PSMA PET/CT
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •6. Adequate haematological, renal, hepatic and pulmonary functions
- •7. Written informed consent provided
- •8. Willingness and ability to comply with all study protocols
排除标准
- •1. prior treatment with radiotherapy or systemic therapies (e.g. androgen deprivation therapy, chemotherapy) for prostate cancer for longer than 21 days
- •2. history of other active malignancy within last 2 years (except non-melanoma skin cancer and superficial bladder cancer)
- •3. severe active co-morbidity or other barrier to completing study processes
研究者
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