We are delighted to announce the successful completion of a phase two clinical study of 68Ga-THP-PSMA (THG-001).
The PRONOUNCED trial is a prospective open-label study of 50 patients to evaluate the safety and clinical impact of 68Ga THP-PSMA PET/CT imaging (THP-PSMA) on patient management and treatment decisions in men who are newly diagnosed or have biochemically recurrent prostate cancer after initial treatment.
Following positive discussions with the FDA earlier in 2019 and having scanned over 1000 patients to date, Theragnostics have a clear route to NDA submission for THP-PSMA. More news will follow over the coming months.
For our full press relase please see here.