Real World-Evidence in Radioligand Therapy: Above and Beyond a Tongue Twister

Radioligand therapy (RLT) is an innovative treatment approach that combines a radioactive isotope with a ligand designed to bind selectively to receptors expressed on tumor cells. This targeted mechanism allows for the delivery of radiation directly to cancer cells, sparing healthy tissue as much as possible.

Controlled clinical trials have demonstrated both the efficacy and safety of RLT, leading to the approval of specific drugs for clinical use. Notably, [177Lu]Lu-DOTATATE has been authorized for the treatment of neuroendocrine tumors (NETs) and [177Lu]Lu-PSMA-617 has been approved for metastatic castration-resistant prostate cancer (mCRPC).

However, despite these promising results, clinical trials often apply strict inclusion criteria, limit the number of patients enrolled and are frequently conducted only in specialized research Centres. As a result, a significant number of potentially eligible patients may be excluded from participating, limiting access to a therapy that could offer substantial clinical benefits.

There is growing interest in evaluating radioligand therapy (RLT) under real-world conditions, where patient populations are typically more diverse and representative of actual clinical practice. Analyzing real-world data (RWD) in this context can offer valuable insights into treatment patterns, long-term outcomes, safety profiles and potential logistical or operational barriers. Such information is critical not only for optimizing patient management, but also for informing the development of more flexible and inclusive clinical guidelines and to support the optimization of RLT use in daily oncology care. Moreover, real-world evidence (RWE) can help clinicians better understand how RLT performs across varied healthcare systems and patient demographics, thus supporting its broader and more equitable implementation. Ultimately, integrating RWD into oncological research is essential for bridging the gap between the ideal conditions of clinical trials and the complexities of everyday medical care.

The scope of this research topic is to gather and present comprehensive experiences of RLT as observed in real-world clinical settings. The focus is on evaluating its effectiveness, safety and overall impact on patient management in routine practice. Particular attention will be given to factors such as patient comorbidities, clinical outcomes, adherence to therapy and potential organizational or logistical challenges that may arise during implementation.

Submissions are encouraged in the form of case reports, original articles and clinical studies. Contributions may include multicenter studies, randomized controlled trials, or any research that highlights the practical applications and challenges of RLT in routine oncology practice.

Article types and fees

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

• Brief Research Report
• Case Report
• Clinical Trial
• Editorial
• FAIR² Data
• FAIR² DATA Direct Submission
• General Commentary
• Hypothesis and Theory
• Methods
• ... View all formats

Articles that are accepted for publication by our external editors following rigorous peer review incur a publishing fee charged to Authors, institutions, or funders.

Article types

This Research Topic accepts the following article types, unless otherwise specified in the Research Topic description:

• Brief Research Report
• Case Report
• Clinical Trial
• Editorial
• FAIR² Data
• FAIR² DATA Direct Submission
• General Commentary
• Hypothesis and Theory
• Methods
• Mini Review
• Opinion
• Original Research
• Perspective
• Review
• Study Protocol
• Systematic Review
• Technology and Code

Keywords: RLT, Radioligand therapy (RLT), nuclear medicine, [177Lu]Lu-DOTATATE, [177Lu]Lu-PSMA, Real world-evidence

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.