Assessing Clinical Utility in Randomized Trials of Radical Prostatectomy for Urologic Oncology: An Original Article of Studies Published Between 2020 and 2024

Abstract

Objective: To assess the clinical usefulness and transparency of randomized controlled trials (RCTs) evaluating radical prostatectomy, given concerns about limited generalizability, transparency, and patient-centered outcomes in surgical research.

Methods: We systematically reviewed 40 RCTs published between 2020 and 2024, evaluating radical prostatectomy (RP) for prostate cancer. Trials were assessed using the van't Hooft framework, which includes seven clinical utility and six transparency criteria. Values were analyzed descriptively and by year, with correlation analyses assessing the relationship between transparency and clinical utility.

Results: Most trials addressed high-impact clinical questions and included patient-centered outcomes, but only 7.5% met full criteria for pragmatic design, and none fully assessed value for money. Protocol transparency and data sharing were limited. A strong positive correlation was observed between transparency and clinical utility (r = 0.74, P <.001). Limitations include potential subjectivity in evaluating and exclusion of unpublished or non-English RCTs.

Conclusion: Despite progress in patient-centeredness and reporting of conflicts and funding, RP trials often fall short in pragmatic design and transparency. Greater adherence to reporting standards and inclusion of economic and real-world relevance are essential for maximizing trial impact in urologic oncology.