Editorial: assessment of 68Ga-PSMA-11 PET accuracy in localizing recurrent prostate cancer, a prospective single arm clinical study: California shows the way!

The article by Fendler et al. published in JAMA Oncology (1) confirms many previous studies of the prostate cancer imaging agent, 68Ga-PSMA-11 PET in the setting of biochemical recurrence (BCR). Like many before it, this study demonstrates the high sensitivity of PSMA PET/CT and PET/MR for detecting sites of disease in the post-treatment BCR setting. However, unlike almost all previous papers it is a large prospective study (n=635) conducted at two US centers (UCSF and UCLA) with carefully controlled eligibility and quality controls. Even with these enhancements, it suffers from the inability to histologically validate most of the PET findings but it provides the highest-level evidence to date for 68Ga PSMA-11 PET. In spite of all the care that went into this study and the strict adherence to modern guidelines for prospective trials compared to trials before it, the results largely reproduce those of far-less controlled studies published over 4 years ago at multiple German centers. While much criticism has been leveled at the anecdotal nature of these first studies, in fact, the field of prostate cancer imaging owes a huge debt of gratitude to these early pioneers of PSMA imaging at numerous German and Australian academic centers who demonstrated the spectacular results that we have all come to expect from PSMA PET and directly led to this study in two California academic centers. Nonetheless, in order for PSMA PET imaging to proceed in the United States, studies of this quality will be necessary to secure FDA approval