Global clinical trial activity in metastatic castration-resistant prostate cancer from January 2020 to March 2026: a landscape analysis
TL;DR
The therapeutic landscape for mCRPC has evolved into a highly diversified and dynamic field, overwhelmingly dominated by early-phase investigations, while radiopharmaceutical therapy (RPT), centered on 177Lu-PSMA, has reached a mature stage of development.
Abstract
Background Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal stage of prostate cancer with poor prognosis. Clinical trials for mCRPC are growing rapidly worldwide. However, a comprehensive systematic analysis of the global research and development landscape in mCRPC remains lacking. Methods This study queried the Trialtrove database for interventional trials in mCRPC registered between January 1, 2020 and March 27, 2026. After exclusion of unrelated trials and non-therapeutic studies, 474 trials were analyzed. Results The therapeutic landscape for mCRPC has evolved into a highly diversified and dynamic field, overwhelmingly dominated by early-phase investigations. Targeted therapy, particularly PARP inhibitors, remain the leading class, while radiopharmaceutical therapy (RPT), centered on 177Lu-PSMA, has reached a mature stage of development. Immunotherapy is expanding beyond checkpoint blockade into bispecific T-cell engagers and cellular therapies, and endocrine therapy is being reshaped by PROTAC degraders. Antibody-drug conjugates (ADCs) are also gaining momentum, with B7 homolog 3 protein (B7-H3) as the most actively pursued targets. Combination regimens account for 39.2% of trials. Conclusion mCRPC clinical research landscape has diversified remarkably, shifting from conventional chemotherapy and endocrine therapy toward mechanism-based, biomarker-guided, and combination-oriented strategies.