A RECENT systematic review has raised concerns about the lack of dedicated mental health monitoring in clinical trials for genitourinary (GU) cancer therapies. Although several new treatments, such as immune checkpoint inhibitors and targeted therapies, have gained FDA approval since 2015, their impact on mental health remains poorly understood.
Researchers analysed 42 clinical trials supporting the approval of 31 GU cancer drugs between 2015 and 2024. While 85% of trials included some form of psychiatric assessment, these were usually embedded within broader quality-of-life (QoL) measures, such as the EORTC QLQ-C30, EQ-5D-5L, and BPI-SF. These tools, while useful, do not specifically target psychiatric conditions and often fail to capture the full extent of emotional and psychological side effects.
Depression and anxiety were the most frequently evaluated symptoms, assessed in 80% of trials. Insomnia appeared in 61%, cognitive impairment and irritability in 38%, and more severe psychiatric issues such as psychosis and delirium were rarely considered, under 2% of trials. Alarmingly, 15% of trials did not include any mental health assessments at all, and long-term psychiatric outcomes were seldom monitored.
These gaps reflect a broader trend in oncology, where psychological distress may be underreported due to stigma, misclassification, or a focus on physical adverse effects. The lack of standardised psychiatric screening tools within trials may lead to incomplete safety profiles and hinder patient support strategies.
The study recommends integrating dedicated psychiatric tools, like the GAD-7 and PHQ-9, into future trials to better capture mental health outcomes. Doing so would provide a clearer understanding of the psychiatric side effects of cancer therapies, improve treatment adherence, and support holistic patient care that values mental as well as physical well-being.
Reference
Teymouri F et al. A decade review of mental health monitoring in clinical trials for United States Food and Drug Administration-approved genitourinary cancer treatments. BJU Int. 2025;DOI:10.1111/bju.16815.
