A Phase Ib/IIa open-label, multicenter, dose-escalation and proof-of-concept trial evaluating Benfo-Oxythiamine (B-OT) as an investigational add-on to standard of care (SOC) lutetium (177Lu) vipivotide tetraxetan therapy (Pluvicto®) in adults with metastatic castration-resistant prostate cancer (mCRPC) and stable disease after two prior cycles of SOC

This trial is open to men aged 18 and over who have advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments.

To be considered, you must have already completed two cycles of standard Pluvicto treatment, and your cancer must currently be stable, meaning it has not grown significantly since starting that treatment.

Because your safety is the top priority, you will also need to meet standard health requirements. These usually include having reasonably healthy kidney, liver, and bone marrow function, and being well enough to attend regular hospital appointments. Your hospital oncology team will be able to check all the detailed medical requirements with you.

Taking part in this study means visiting a hospital clinic regularly while you receive your planned cancer care. In addition to your standard Pluvicto treatment, you will be given the experimental drug, Benfo-Oxythiamine. During the first few weeks, doctors will monitor you closely to check how your body handles the medicine. You will have regular health assessments, including physical examinations, blood tests, heart checks (ECGs), and specialised imaging scans (such as PET and CT scans) to see how your tumours respond. You may also need to give small blood samples so researchers can see how the drug is processed in your bloodstream. Your participation will last across your treatment cycles, followed by regular check-ups to track your long-term health and wellbeing.