Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

To be considered for this study, men typically had to have prostate cancer that had spread in their body. A special scan needed to show that their cancer had a specific target called PSMA. Their cancer also needed to be getting worse, despite previous treatments. Importantly, their body organs like the kidneys, liver, and blood needed to be working well enough to receive treatment.

Some men would not have been able to join. For example, if they had received any other new investigational or anti-cancer treatments within 28 days of the planned start of this study. Men with severe or uncontrolled pain, or those who had problems with their brain or spine due to cancer spread, were also typically excluded. Heart problems, such as a heart attack or severe chest pain within the last 6 months, would also usually prevent participation.

The study also couldn't include men who had other types of cancer in the last three years that might affect how long they were expected to live or make it hard to check how their prostate cancer was responding to treatment.

This study has completed its enrollment, meaning no new patients are being accepted. If you had taken part, it would have involved a number of visits to the study centre for check-ups, scans, and to receive the study medication (225Ac-PSMA-R2). You would also have had special scans using 68Ga-PSMA-R2 or 68Ga-PSMA-11, which help researchers see the cancer and how the treatment is working. Throughout the study, doctors and nurses would have closely monitored your health and any side effects. The total duration of participation, including follow-up, would have depended on how well you responded to treatment and generally continued for as long as the treatment was helping or until side effects became too much. This was an 'open label' study, meaning both you and your doctors would know which medication you were receiving.