CTRI/2019/12/022282进行中（未招募）2 期
Efficacy and Safety of Lutetium â?? 177 PSMA Radioligand Therapy versus Docetaxel in Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
入选标准
- •1.Biopsy proven adenocarcinoma prostate
- •2.Castration resistant prostate cancer defined by castrate serum testosterone <50 ng/dl or 1.7 nmol/l plus one of the following types of progression:
- •a.Biochemical progression: Three consecutive rises in PSA one week apart, resulting in two 50% increases over the nadir, and PSA >2 ng/ml.
- •b.Radiologic progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using the Response Evaluation Criteria in Solid Tumours.
- •3.Metastatic disease (as established by 68Ga â?? PSMA PET/CT)
- •4.Significant PSMA expression in 68Ga â?? PSMA PET/CT defined as SUVmax of lesion being significantly (1.5 x) greater than that of normal liver and/or SUVmax of >=10
- •5.Chemotherapy naive patients; patients with prior treatment of new generation antiandrogens will however be included
- •6.ECOG performance 0-2
- •7.Adequate renal function â?? GFR >= 40 mL/min (as estimated by 99mTc DTPA GFR)
- •8.Stable haematological parameters:
- •a.Hb >= 9 g/dL
- •b.Neutrophils >= 1500/mcL
- •c.Platelets >= 75000/mcL
- •9.Adequate liver function:
- •a.Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
- •b.AST or ALT <= 1.5 x ULN (or <= 5.0 x ULN in the presence of liver metastases)
- •c.Albumin >= 2.5 g/dL
排除标准
- •1. Prostate cancer with sarcomatous/spindle cell/small cell differentiation
- •2. PSMA expression in 68Ga â?? PSMA PET/CT, SUVmax <10 and less than liver
- •3. Sjogren Syndrome
- •4. Prior treatment with Docetaxel/Cabazitaxel/Lu PSMA
- •5. Active malignancy other than prostate cancer
- •6. Concurrent illness, including severe infection
研究者
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