TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT06520345

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Overview

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

Phase

Phase 3

Contacts

Telix Medical Director

info@telixpharma.com

ClinicalTrials.gov

NCT06520345

Eligibility

Inclusion

  • Must have received minimum 12w prior therapy with no more than one NAAD (enzalutamide and/or abiraterone + prednisone)
  • Can be receiving a bisphosphonate or denosumab regimen
  • Received one line of prior taxane therapy or have refused or be ineligible for taxanes
  • Have disease that is progressing despite a castrate testosterone level

Exclusion

  • Have received prior treatment with radioisotopes or any PARP inhibitors
  • Have received prior treatment of monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy
  • Uncontrolled pain
  • Have PC associated with findings consistent with small cell or any histology other than adenocarcinoma of the prostate
  • Known brain or hepatic metastases

Patient Education

Patient education not yet provided.

Publications

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