Pivotal Phase 3 Theranostic Trials: Future Indications.

Authors

Wolfgang P Fendler, Michael S Hofman, David Kersting, Jeremie Calais, Thomas A Hope

Published in

Journal of nuclear medicine : official publication, Society of Nuclear Medicine. Volume 67. Issue Suppl 2. Pages 30S-35S. Sep 11, 2026. Epub Sep 11, 2026.

Abstract

There are several ongoing phase 3 randomized trials involving radiopharmaceutical therapies (RPTs), which are expected to provide practice-changing evidence in the coming years. This review covers ongoing pivotal phase 3 trials designed to expand applications for RPTs. Trials such as PSMAcTION, STAMPEDE2, PSMA-DC, and PSMAddition focus on prostate-specific membrane antigen-directed treatments for patients with prostate cancer. NETTER-3, ACTION-1, and COMPOSE evaluate somatostatin receptor-targeted radiopharmaceuticals in individuals with neuroendocrine neoplasms. Expansion of phase 3 registration trials has been driven by increased industry investment. Ongoing RPT phase 3 trials serve as hybrids, merging nuclear medicine procedures for imaging and drug application with oncology-driven standards of care and endpoint definitions. Despite the challenges associated with this integration, phase 3 RPT trials present an opportunity to revolutionize future cancer care by introducing and expanding the use of image-guided RPT.

PMID:
42728102
Bibliographic data and abstract were imported from PubMed on 12 Sep 2026.

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