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Clinical Trial Summary

This phase II study will investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC).


Clinical Trial Description

This is an open label, randomised, stratified, multicentre phase 2 clinical trial recruiting 110 participants over 18 months and followed for 12 months. Participants will be randomised to 177Lu-PSMA in combination with Ipilimumab and Nivolumab and 177Lu-PSMA alone in a 2:1 ratio (using minimisation with a random component) stratified by prior exposure to docetaxel. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05150236
Study type Interventional
Source Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 29, 2022
Completion date December 2024

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