Industry Sponsorship and Disease Site Focus in Therapeutic Radiopharmaceutical Clinical Trials Over the Past Decade

作者：Jackson N. Howell, Jacob Wilkes, Nichole M. Maughan, Ravi B. Patel, Brandon M. Barney, Neil K. Taunk, Freddy E. Escorcia, Skyler B. Johnson, Dustin Boothe · 发表于：International Journal of Radiation Oncology*Biology*Physics · 年份：2025 · DOI：10.1016/j.ijrobp.2025.09.028 · 被引用次数：1 · 研究领域：Radiopharmaceutical Chemistry and Applications、Pharmaceutical industry and healthcare、Prostate Cancer Treatment and Research

Purpose Recent regulatory approvals of radiopharmaceutical therapies (RPTs) have brought increased attention to the modality. Knowledge of the RPT clinical trial landscape and its evolution will help practicing radiation oncologists prepare for the next generation of RPTs as they enter routine clinical practice. Methods We queried ClinicalTrials.gov for therapeutic RPT clinical trials posted between 2014 and 2024. After excluding diagnostic and yttrium-90 [ 90 Y] microsphere therapeutic trials, we analyzed each posting. We characterized overall and temporal trends in primary disease site, trial phase, primary and secondary endpoints, industry sponsorship, and radioisotope/radioligand selection. Annual rates of change in trial postings and industry sponsorship were analyzed using Poisson and fractional logistic regression methods. Results The initial searches yielded 856 RPT clinical trials. After screening, 254 RPT trials were analyzed. The total number of annual trial postings demonstrated considerable growth during this period, with an approximate 13.0% year-over-year increase between 2014 and 2024. Prostate and neuroendocrine gastrointestinal cancers were the most commonly studied disease sites, accounting for 61.8% of trials. Efficacy and safety endpoints were the most common primary and secondary endpoints; however, notably, 24.4% of trials utilized a patient-reported quality of life indicator as a secondary endpoint. Trials involving lutetium-177 [ 177 Lu]-based agents ...