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A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Other Non-Commercial Sponsor
Prostate Cancer Foundation of Australia
The aim of this study is to determine the activity and safety of LuPSMA radionuclide therapy.
Patients with metastatic prostate cancer who have progressed despite hormonal therapy and chemotherapy, will be randomised to receive either LuPSMA radionuclide therapy (up to a maximum of 6 cycles of therapy) or cabazitaxel chemotherapy (up to a maximum of 10 cycles of therapy).
200 participants will be recruited from sites across Australia.
The study will determine the effects on PSA response rate (primary endpoint), pain response, progression free survival, quality of life, and frequency and severity of adverse events. Correlative outcomes include associations between PET imaging and clinical outcomes, and biomarkers and clinical outcomes.