Evaluation of quality of life endpoint planning and reporting in phase III genitourinary oncology randomized controlled trials.

Abstract

720 Background: Quality-of-life (QoL) endpoints are vital for assessing patient-centered outcomes in genitourinary (GU) cancers, yet their inclusion and reporting remain inconsistent. This study evaluated alignment between prospectively registered QoL plans and published results in contemporary phase III GU randomized controlled trials (RCTs). Methods: Phase III GU RCTs published between January 2020 and December 2024 were identified via PubMed. Corresponding ClinicalTrials.gov records were reviewed to determine whether QoL endpoints were prospectively planned. For each trial, published results were examined in primary and secondary manuscripts to assess whether QoL data were reported. Trial characteristics included tumor site, therapy class, funding source, disease setting, study result, and journal impact factor (IF). Additional design and registry variables were explored for associations with QoL reporting. Significant differences in QoL reporting were determined based on Chi-squared or Fisher’s exact tests. Results: A total of 79 phase III GU RCTs were included; 32 (41%) reported QoL outcomes. Sites included prostate (32, 41%), kidney (26, 33%), and bladder (19, 24%). Industry funding and publication in journals with an IF ≥ 10 occurred in 55 (70%) trials; 46 (61%) had positive results. Of 77 trials with registry data, 45 (58%) prospectively planned QoL assessment, yet 17 (38%) failed to publish results. QoL findings appeared in primary manuscripts for 17 (53%) and in secondary publications for 15 (47%). RCTs with positive results were more likely to report QoL than negative trials (26/46 [57%] vs 5/30 [17%]; p = 0.001). High-impact journals reported QoL more often than lower-impact journals (27/55 [49%] vs 5/24 [21%]; p = 0.019). Reporting did not differ by tumor site, disease setting, therapy class, study design, masking, or geographic scope (all p > 0.05). Industry-funded RCTs showed a trend toward higher reporting rates (26/55 [47%] vs 6/24 [25%]; p = 0.064). Conclusions: QoL outcomes were inconsistently reported in contemporary phase III GU oncology RCTs. Despite prospective planning in over half of the studies, more than one-third failed to publish QoL results. Trials with positive efficacy findings were approximately three times more likely to report QoL outcomes, underscoring the need for improved transparency and adherence to prespecified patient-reported outcome measures and reporting standards.