Abstract
AbstractThroughout the world, hundreds of patients with advanced metastatic prostate cancer are currently being treated with 177Lu-PSMA radioligands on compassionate usage protocols in accord with published guidelines of the European Association of Nuclear Medicine (EANM). However, 7 years after the introduction of 68Ga/177Lu-PSMA theranostic management of metastatic castration-resistant prostate cancer (mCRPC), it remained unapproved by any national regulatory authority, and has yet to achieve oncologist/urologist acceptance into mainstream clinical practice. The reasons for the nonacceptance of 177Lu-PSMA-radioligand therapy (RLT) are explored in this review, which charts the evolution of this very promising treatment modality, pioneered in German, Austrian, and Australian academic hospitals, from which many retrospective reports of efficacy have been published. This efficacy has subsequently been demonstrated by completion of the Pharma randomized controlled trial, the VISION Study which led to formal regulatory approval. However, in order to promote worldwide availability, and to evaluate efficiency in respect of improved survival and quality of life, the proposed WARMTH NIGHTCAP (World Association for Radiopharmaceutical and Molecular Therapy National Investigators Global Harmonised Theranostics of Cancer of Prostate) Study was designed to prospectively audit 68Ga/177Lu-PSMA RLT in a large real-world population of mCRPC patients, in up to 50 countries, now being treated on compassionate access programs. The NIGHTCAP Study did not come to fruition due to the COVID pandemic but the design principles remain valid.
Publisher
Springer International Publishing