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Evidence Base for the Use of PRRT.

The development of peptide receptor radionuclide therapy (PRRT) in disseminated neuroendocrine tumors (NETs) has been a long and protracted process. The idea was born within nuclear medicine academia but its translation to clinical practice has been marked by misunderstanding of the rigors of the processes used in drug registration. There were several false starts and some of the required basic science did not occur until after first in man studies. The standard process of preclinical, phase 1, 2 and 3 clinical trials were sometimes blurred and the required data including the assurances that patients were studied on protocol was missing from subsequent publications. Despite this there was a growing conviction and increasing evidence that the use of PRRT had a positive benefit in both survival and symptom relief in about 80% of treated patients. After a decade and a half of false starts and incomplete data a formal randomized controlled trial was conducted comparing PRRT with high dose somatostatin which clearly proved that PRRT was both safe, effective and the treatment of choice in hormone refractory NETs.