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 Pharmaceuticals

Contacts:

Telix Medical Director

info@telixpharma.com

Government Study Link:

NCT04876651 - Click here to see study on

ClinicalTrials.gov

Inclusion

Have disease that is progressing despite a castrate testosterone level
Can be receiving a bisphosphonate or denosumab regimen
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)

Exclusion

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
Have PC associated with findings consistent with small cell or any histology other than adenocarcinoma of the prostate
Uncontrolled pain
Known brain or hepatic metastases

Patient Education

Patient Education Not Yet Provided

Publications

Abstract from ASCO-GU 2024

Locations

United States

XCancer - Omaha

17607 Gold Plaza, Omaha, Nebraska 68130, United States

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