177Lu-TLX591-203
Research type
Research Study
Full title
A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (PSMA) Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) after Androgen Receptor Pathway Inhibitor (ARPI) Treatment
IRAS ID
1012180
Contact name
Lucy Baker-Whittington
Contact email
Sponsor organisation
Telix Pharmaceuticals (Innovations) Pty Limited
Eudract number
2024-513798-39
Clinicaltrials.gov Identifier
Research summary
This study is being run by Telix Pharmaceuticals (Innovations) Pty Ltd.
The investigational medicinal product (IMP) 177Lu-TLX591 is a radiopharmaceutical therapy candidate for the treatment of Prostate-Specific Membrane Antigen (PSMA) positive advanced Prostate Cancer.
This study is open to male participants aged 18 years or older who have metastatic castration resistance prostate cancer that expresses PSMA despite prior treatment. Participants will receive treatment with either 177Lu-TLX591 as an infusion into a vein + standard of care (SOC) therapy, or SOC therapy alone. The objective of this study is to determine if combining 177Lu-TLX591 with SOC treatments is more effective than the SOC treatment alone. Participants will be followed for progression of their cancer by non-invasive imaging such MRI, PET/CT or PET/MRI scans and standard CT scans of the chest, abdomen and pelvis, and nuclear medicine bone scans.
The study will enrol a total of approximately 520 participants at approximately 100 sites globally and will consist of:
Part 1: Safety and Dosimetry Lead-in, which will enrol 30 participants,
Part 2: Randomization Treatment Expansion, which will enrol up to 490 participants,
A Long-term Follow-up Period, which will be completed by all Part 1 and Part 2 participants.
Part 1 will not be conducted in the UK.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0258
Date of REC Opinion
17 Oct 2025
REC opinion
Further Information Favourable Opinion