CTRI/2020/10/028341尚未招募2 期
Radionuclide therapy with 177Lu-PSMA plus Abiraterone (with ADT) versus Abiraterone (with ADT) alone in metastatic, hormone-sensitive prostate cancer: a randomized phase 2 trial - REPLASE
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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 of the prostate
- •2.Metastatic disease (poly metastatic â??more than 3 metastatic lesions) evident on
- •imaging (CT and/or bone scan/Ga PSMA).
- •3. Patients who are planned for treatment with Abiraterone.
- •3.PSMA-avid disease on Ga PSMA scan (uptake equal or more than the liver)
- •5. ECOG performance status 0-2
- •5.Participant is willing to comply with all study treatments, procedures, and assessments
- •6.Signed, written, informed consent.
排除标准
- •1.ADT started more than 13 weeks prior to randomisation
- •2.Rising PSA after starting ADT for metastatic disease.
- •3.Sjogrens disease are other contraindications to Lu-PSMA.
- •4.Oligometastatic disease â?? who have less than 3 or 3 metastatic lesions.
- •5.Other active malignancy within the last 3 years that has not been treated adequately with curative intent.
- •6.Poor renal function â?? serum creatinine > 1.6mg/dl or a creatinine clearance of < 50 ml/min.
- •7.Compromised bone marrow function-
- •Hemoglobin level < 9 g/dl
- •Platelets < 1,00,000 per cubic milliliter
- •WBC count less than 2000 millilitre.
- •8.Compromised liver function â??
- •Total bilirubin level more than 1.5 times the normal
- •9.Estimated life expectancy less than 6 months.
研究者
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