Letters COMMENT & RESPONSE We apologize for our US-centric view of the current com- mercial availability of PSMA agents. Admittedly, we have an In Reply We thank Perera and colleagues for their comments incomplete understanding of the approval process for PET on our article. Indeed, the current state of histologic confir- agents outside the United States and we are happy to learn of mation of prostate-specific membrane antigen (PSMA) posi- the broad availability of the agent across several continents. tron emission tomography (PET) scans is less than ideal, as they The US approval system must appear equally opaque to out- point out in their meta-analysis in which only 5 of the 16 stud- siders. As for the United States, a commercial product is sev- ies that were evaluated had histologic confirmation. All were eral years down the road, awaiting the results of several in- retrospective, relatively small single-institution studies (12- dustry-sponsored multi-institutional prospective trials that 130 patients). The majority were based on preoperative stag- include biopsy confirmation. We agree, PSMA radiotracers are ing studies of intermediate- or high-risk primary cancers prior revolutionizing the field and we are hopeful for their sus- to radical prostatectomy, a bias by itself because
JAMA Oncology – American Medical Association
Published: Jun 22, 2018
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