SatisfACtion: A Phase I/II, open-label, multi-center study of [225Ac]Ac-PSMA-R2 in men with metastatic hormone sensitive prostate cancer (mHSPC) and in men with heavily pre-treated PSMA positive metastatic castration resistant prostate cancer (mCRPC) with or without prior 177Lu-labelled PSMA-targeted radioligand therapy

This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Mark Voskoboynik

Key inclusion data

adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC); Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading; 18 years and older.