Radionuclide therapy using 177Lu-PSMA: extension of a pilot study in men with castrate-resistant prostate cancer to determine the clinical benefit of combination therapy with idronoxil

St Vincent's Hospital Sydney0 个研究点目标入组 56 人开始时间: 2018年6月27日最近更新: 2022年6月27日

试验速览

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•1.Pathologically confirmed prostate adenocarcinoma
•2.Castration-resistant metastatic disease, including prior treatment with Abiraterone, Enzalutamide or both (unless contraindicated, medically unsuitable or patient refuses)
•3.Prior Taxane-based chemotherapy (unless contraindicated, medically unsuitable or patient refuses)
•4.Objective evidence of disease progression within 6 months of study entry as defined by either:
•a.Radiologic progression (RECIST v1.1 criteria) on conventional imaging
•b.Symptoms refractory to standard medical care
•5.PSMA PET/CT demonstrating uptake intensity significantly greater than liver at sites of disease
•6.Written informed consent.

•1.Estimated GFR < 40 ml/min
•2.Platelet count <100, 000 x109 /L
•3.Neutrophil count < 1.5 x109 /L
•4.Hb < 10.0 g/dL
•5.Albumin less than or equal to 25
•6.Hydronephrosis (untreated)
•7.Concomitant nephrotoxic drugs (e.g. aminoglycosides)
•8.ECOG performance status > 3
•9.Life expectancy of less than 12 weeks
•10.Age <18 years
•11.FDG PET/CT demonstrating sites of major discordant disease (i.e. FDG + PSMA-)
•12.Recent radiotherapy (within 6 weeks) to sole sites of assessable disease
•13.Uncontrolled intercurrent illness that would limit compliance with study protocols
•14.Unable to comply with study protocol.

发起方

St Vincent's Hospital Sydney