ACTRN12618001073291
Completed
Phase 1
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 sites56 target enrollmentJune 27, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- St Vincent's Hospital Sydney
- Enrollment
- 56
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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