Study Title
177Lu rosopatamab tetraxetan With Best Standard of Care (SoC) for the Second Line of Treatment for Metastatic Castrate-resistant Prostate Cancer, Which Expresses PSMA
Study Details
Description:
A multinational, multicenter, prospective, randomized, controlled, open label Phase III study designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu rosopatamab tetraxetan administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase III will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).
Sponsor:
Telix PharmaceuticalsContacts:
Telix Medical Directorinfo@telixpharma.com
Government Study Link:
NCT04876651 - Click here to see study onClinicalTrials.gov
- Received one line of prior taxane therapy or have refused or be ineligible for taxanes
- Must have received minimum 12w prior therapy with no more than one NAAD (enzalutamide and/or abiraterone + prednisone)
- Have disease that is progressing despite a castrate testosterone level
- Can be receiving a bisphosphonate or denosumab regimen
- Known brain or hepatic metastases
- Uncontrolled pain
- Have PC associated with findings consistent with small cell or any histology other than adenocarcinoma of the prostate
- Have received prior treatment of monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy
- Have received prior treatment with radioisotopes or any PARP inhibitors
Patient Education
Patient Education Not Yet Provided
Publications
Locations
Australia