Pivotal Phase 3 Theranostic Trials: Future Indications
- Author(s)
- Fendler, WP; Hofman, MS; Kersting, D; Calais, J; Hope, TA;
- Details
- Publication Year 2026-09-11,Volume 67,Issue #9 Suppl 2,Page 30S-35S
- Journal Title
- Journal of Nuclear Medicine
- Publication Type
- Review
- 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.
- Publisher
- Society of Nuclear Medicine and Molecular Imaging
- Keywords
- Humans; *Clinical Trials, Phase III as Topic; Radiopharmaceuticals/therapeutic use; *Theranostic Nanomedicine/methods; Male; Neuroendocrine Tumors/radiotherapy; Prostatic Neoplasms/radiotherapy; clinical trial; phase 3; prospective; theranostic
- Department(s)
- Cancer Imaging
- Publisher's Version
- https://doi.org/10.2967/jnumed.125.269486
- Open Access at Publisher's Site
https://doi.org/10.2967/jnumed.125.269486- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2026-10-28 06:10:07
Last Modified: 2026-10-28 06:10:23