An early phase clinical trial evaluating the effectiveness of treatment of 177Lu-PSMA with idronoxil in men with castrate-resistant prostate cancer (LuPin Trial)
- Conditions
- Castrate-resistant prostate cancerCancer - Prostate
- Registration Number
- ACTRN12618001073291
- Lead Sponsor
- St Vincent's Hospital Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 56
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method