At EAU25, Dr. Francesco Pellegrino from IRCCS San Raffaele Scientific Institute presented a crucial analysis on the generalizability of randomized trials in newly diagnosed metastatic prostate cancer (mPCa). Using the MarketScan database, the team assessed 4,804 mPCa patients against eligibility criteria from 12 major RCTs, including CHAARTED, STAMPEDE, ARASENS, and ENZAMET.
Only 38% of patients would have been eligible for all trials, while 8% qualified for none. SWOG-1216 excluded over half of real-world patients, whereas HORRAD had the most inclusive design. Cardiovascular disease was the most frequent exclusion factor.
These results highlight a clear gap between trial populations and clinical reality, emphasizing the need for future studies to adopt broader, more inclusive criteria to improve the relevance of evidence-based care in mPCa. The study contributes to the goals of the PIONEER IMI initiative, aiming to strengthen data-driven, patient-centered decision-making.
This collaborative work included contributions from G. Gandaglia, B. De Meulder, T. Abbott, A. Golozar, D. Kotik, T. Roggenkamp, R. Nicoletti, J. Gomez-Rivas, C. Steinbeisser, S. Evans-Axelsson, A. Briganti, A. N’Dow, and A. Hijazy.
For more information, see the full presentation: https://lnkd.in/dWSv7_3U
