The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
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:
NCT06520345 - Click here to see study onClinicalTrials.gov
- 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
- 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
Locations
United States 🇺🇸
17607 Gold Plaza, Omaha, Nebraska 68130, United States
Miami, Florida 33165, United States
Australia 🇦🇺
Perth, Western Australia, Australia
Woolloongabba, Queensland, Australia
Victoria, Australia
Sydney, New South Wales, Australia
Victoria, Australia
New Zealand 🇳🇿
Auckland, Auckland, New Zealand
