Assessing the uptake of core outcome sets in randomized controlled trials for localized prostate cancer: A...

To evaluate core outcome set (COS) completion recommended in localized prostate cancer (LPC) randomized controlled trials (RCTs).

We identified the original LPC COS from 2017 established by the Core Outcome Measures in Effectiveness Trials Initiative. We conducted a search of LPC RCT registries between 2013 and 2023 from databases on ClinicalTrials.gov and International Clinical Trials Registry Platform (ICTRP) via who.int. We screened RCTs from our search in a masked, duplicate fashion. We extracted trial characteristics and specific COS outcomes for survival, bodily functions, quality of life, and treatment-specific outcomes again in a masked, duplicate fashion. COS uptake results were analyzed using an interrupted time series analysis.

Our initial search of ClinicalTrials.gov and ICTRP yielded 13,909 trials. After exclusions, we extracted data from 82 clinical trials. "Disease Progression" (76/82; 92.68%) was the most commonly measured outcome while "Need for Salvage Therapy" (27/82; 32.93%) was the least. Limitations include lack of generalization for other COSs and inability to confirm systematic search returned all pertinent trials.

A nonsignificant decrease in COS adherence prior to the publication of a COS for LPC in 2017 occurred, then a subsequent nonsignificant increase in COS adherence after. We recommend LPC clinical trialists adhere to the COS outlined in our study and that further uptake studies be done to assess future LPC COS adherence.