Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

P1/2, N=148, Active, not recruiting, OncoC4, Inc. | Recruiting --> Active, not recruiting

P2, N=110, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2028 --> Apr 2026

By situating PSMA within this broader biomarker landscape, we outline opportunities for theranostic integration, including predictive models, combination therapies and expansion into non-prostate malignancies. Understanding the biology of PSMA in conjunction with novel biomarkers provides a framework for optimising theranostic applications and advancing personalised cancer care.

In 2018, the Food and Drug Administration (FDA) approved lutetium-177 (177Lu) DOTATATE (LUTATHERA, Advanced Accelerator Applications [Novartis]) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)...Less than 5 years later, in March 2022, 177Lu vipivotide tetraxetan (PLUVICTO, Advanced Accelerator Applications) received FDA approval for the treatment of prostatespecific membrane antigen-positive castration-resistant metastatic prostate cancer...As more radiotheranostic agents and applications get adopted in clinical practice, interventional radiologists are likely to get exposed to this field in a way or another. In this article, we discuss the fundamentals of radiotheranostic therapy and explore the expanding role interventional radiology (IR) is expected to play as an essential partner in modern oncology practice.

P1/2, N=123, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting

Two RLT agents, [177Lu]Lu-DOTA-TATE (Lutathera®) and [177Lu]Lu-PSMA-617 (Pluvicto®), have received regulatory approval for the treatment of advanced gastroenteropancreatic neuroendocrine tumours and metastatic castration-resistant prostate cancer, respectively. Finally, we outline the main clinical challenges, including fixed dosing regimens, resistance, toxicity, and variability in patient selection and response assessment. Continued research to optimise radiopharmaceutical design, together with investment in infrastructure, workforce capacity, and international collaboration, will be essential to expand access and realise the full potential of RLT as a leading treatment strategy in modern oncology.

P1/2, N=123, Not yet recruiting, Novartis Pharmaceuticals

P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Trial primary completion date: Jun 2026 --> Aug 2025

P1, N=27, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026

P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center

P3, N=450, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2027 --> Apr 2028