Mental health monitoring in clinical trials for FDA-approved genitourinary cancer treatments: A decade review.

Abstract

696 Background: The treatment landscape for genitourinary (GU) malignancies, including bladder, kidney, and prostate cancers, has evolved with several novel therapies approved in the past decade. The importance of mental health in patients with cancer is being more and more recognized in the past years. This study evaluates the monitoring of mental health and psychiatric symptoms in trials leading to FDA approvals for GU cancers. Methods: We comprehensively reviewed trial protocols and publications for FDA-approved GU cancer therapies from 2015-2024. For each approved therapy, we examined whether psychiatric side effects were monitored, the tools used, and the timing of assessments. Results: Of 42 trials for 31 approved treatments, 85% (36/42) monitored some psychiatric monitored psychiatric or mental health-related outcomes. EORTC QLQ-C30, EQ-5D-5L, and BPI-SF were the most common tools used for monitoring. However, 15% of trials did not assess mental health, and long-term follow-ups were inconsistent as described in the table. Depression and anxiety were the most evaluated symptoms. Nonetheless, the majority of the other psychiatric manifestations were not consistently assessed throughout trials. Conclusions: Psychiatric monitoring is present in many GU trials but remains inconsistent. Mental health assessments are typically part of broader quality-of-life evaluations rather than focused psychiatric tools. Future trials should adopt standardized psychiatric assessments to better manage patient well-being during treatment. Psychiatric symptoms monitoring in FDA-approved GU cancer trials - 2015 to 2024. Symptom Assessed (%) Baseline Long-Term Publications Prostate Kidney Bladder Depression 80% Yes Yes No Yes Yes Yes Anxiety 80% Yes Yes No Yes Yes Yes Insomnia 61% Yes Yes Yes Yes Yes Yes Cognitive Impairment 38% Yes Yes No Yes Yes Yes Irritability 38% Yes Yes No Yes Yes Yes Emotional Lability 9% Yes Yes No Yes No Yes Delirium 2% No No No No Yes No Psychosis 2% No No No No Yes No