OBJECTIVES: Given the significant population of prostate-cancer(PCa) survivors and the value of assessing quality-of-life (QOL) in PCa, four patient-reported-outcome(PRO) domains (physical and mental well-being, fatigue, and pain) have been identified as priorities for assessment by a National Cancer Institute (NCI) working group on the inclusion of PRO measures in PCa clinical trials. Additional areas of impact are therapy related adverse events, social functioning, and coping. This review summarizes trends and gaps of PCa-specific PRO endpoints from randomized controlled trials of approved (as well as pre-approval) PCa treatment.

METHODS: This cross-sectional descriptive review was conducted, including completed phase III and IV clinical trials posted on the “ClinicalTrials.gov” as of December 2023. No restriction was applied on the time frame of the search and age group or gender of PCa patients. Terminated, recruiting, or withdrawn trials were excluded from the search. Keywords such as “Prostate Cancer,” “CRPC,” "mCRPC", “patient-reported outcomes,” “PRO,” and “health-related-quality of life” etc. were used to initiate the search. Four PRO domains (physical and mental well-being, fatigue, and pain), as suggested by NCI, measures were reported. A trend of reported PRO endpoints was summarized and gaps in terms of how adequately a PRO measure covers key impacted areas were explored by looking into the domains of each PRO measure.

RESULTS: Search identified 184 PCa clinical trials incorporating PRO endpoints. Expanded-Prostate-Cancer-Index-Composite-26 (EPIC-26) and European-Organization-of-Research-and-Treatment in Cancer (EORTC-QLQ-C30) were reported in most studies as QoL instrument. Pain (n=90), and mental well-being (n=63) were the most studied PRO domains. Brief-Pain-Inventory (BPI) Questionnaire was reported in most of the studies to measure the pain related PRO. Anxiety and depression, measured using hospital anxiety and depression Scale (HADS) Score, were the most studied sub domain within mental well-being related PRO.

CONCLUSIONS: Results reflected a gap in terms of full coverage of key impacted areas from a patient’s perspective.