ProstACT Global: A Phase 3 study of 177Lu rosopatamab tetraxetan (TLX591) plus standard of care (SoC) versus SoC alone in patients with metastatic castration-resistant prostate cancer (mCRPC)
Patient Summary
What is TLX591?
TLX591 comprises a radioactive isotope, Lutetium-177, attached to an antibody called rosopatamab. Rosopatamab targets prostate-specific membrane antigen (PSMA), a protein expressed on the surface of prostate cancer cells, which is low or absent on most normal healthy cells.
What is PSMA?
When you have prostate cancer, you may have a lot more PSMA than normal, particularly in the prostate cancer cells and other areas where the cancer may have spread (called metastatic lesions). This can make PSMA a good target for treating advanced prostate cancer.
Why Participate in This Study?
This global Phase 3 study is designed to investigate and confirm the benefits and risks associated with TLX591 administered together with standard of care (SoC), as compared to the best SoC alone. The study is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) that expresses PSMA and has progressed despite prior treatment with hormone therapy.
What Will Happen in the Study?
In this randomized study, participants will be assigned by chance, not choice, to receive either TLX591 plus standard of care (SoC) or SoC alone.
Inclusion:
Male 18 years of age or older:
- Documented tumor of the prostate defined by biopsy
- A minimum of 12 weeks of prior therapy with a hormone therapy in any disease setting
- Disease which has spread beyond the prostate
- Castration-resistant prostate cancer
- PMSA-positive disease as demonstrated by 68Ga-PSMA-11 PET/CT or PET/MRI
Exclusion:
- Prior therapy with TLX591, or any other PSMA-targeted therapy
- Prior chemotherapy (with the exception of docetaxel if more than 6 months prior to entering the study)
- Prior radiation therapy within 4 weeks of entering the study
- Prior treatments with radioisotopes
Organization:
For additional information, visit telixpharma.com
ClinicalTrials.gov Information:
- NCT Number: NCT06520345
- Title: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
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Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
