Our study of a new radiopharmaceutical PSMA formulation that can be rapidly manufactured from a 68Ga generator and cold-kit vial demonstrates that 68Ga-THP-PSMA PET-CT impacts on management decisions in HR prostate cancer prior to radical therapy and BCR, despite lower scan positivity rates at PSA levels < 0.5 μg/L. This evidence concerns the gene KLK3 and Familial prostate cancer.