Despite growing interest in patient-centered research, quality-of-life end points remain inconsistently reported in phase 3 trials of genitourinary (GU) cancers.
A systematic review of randomized controlled trials, presented at the 2026 ASCO Genitourinary Cancers Symposium, found that although most trials initially included quality-of-life measures, fewer than half ultimately published these outcomes. This gap between trial design and dissemination may limit the ability of clinicians and patients to fully understand the impact of therapy beyond traditional clinical endpoints.
"QoL end points are essential for assessing patient-centered outcomes in GU cancers, yet their inclusion and reporting in clinical trials remain inconsistent,” lead author, Dr. Shreyas Kalantri, wrote in a poster presentation of the data. “Despite growing emphasis on PROS, significant gaps persist between QoL planning at trial registration and subsequent publication of results.”
Kalantri works in the Division of Medical Oncology/Hematology, Brown Cancer Center, University of Louisville.
Background and rationale
Investigators conducted a comprehensive review of published phase 3 GU trials between 2020 and 2024, cross-referencing trial protocols and registries to determine whether quality-of-life measures had been planned prior to patient enrollment. Trials were categorized by cancer type, disease stage, treatment approach, funding source, and primary outcomes. The researchers then examined whether planned quality-of-life outcomes were ultimately reported in main publications, secondary publications, both, or not at all.
Glossary
Quality of Life (QoL): How treatment or disease affects a patient’s physical, emotional, and social well-being.
Patient-Reported Outcomes (PROs): Information reported directly by patients about their health, symptoms, and functioning.
Phase 3 Clinical Trial: A late-stage study designed to compare the effectiveness of a new treatment against the current standard of care.
CONSORT-PRO Guidelines: Standards for reporting patient-reported outcomes in clinical trials to ensure transparency and consistency.
This review aimed to assess whether modern GU trials are fully capturing the patient perspective, an increasingly important consideration as therapies become more intensive and disease control improves.
Study design and reporting patterns
Among the 80 trials reviewed, prostate cancer was the most common disease site, followed by kidney and bladder cancers. Most trials focused on metastatic disease, with the remainder addressing perioperative or locally advanced and recurrent settings. Trials were split roughly evenly between combination therapy approaches and single-agent strategies. The majority of studies were industry-funded, and most were conducted across multiple countries, reflecting the international nature of contemporary GU oncology research.
Although nearly all trials included quality-of-life measures at the time of registration, reporting was inconsistent. Less than half of studies actually published these findings, either in the primary paper or in a secondary publication. Some trials reported only partial results, while others did not report patient-centered outcomes at all. Reporting rates were higher among trials that met their primary efficacy endpoints, suggesting that selective reporting may influence which quality-of-life data are disseminated.
The analysis also highlighted a concerning trend over time, with fewer trials publishing quality-of-life results in the later years of the review period. This temporal decline raises questions about whether growing trial complexity or other factors are influencing the consistency of patient-centered reporting.
Additional findings and implications
Incomplete reporting of quality-of-life outcomes may obscure important information about how treatments affect daily functioning, symptom burden, and overall well-being. While adverse event data provide insight into tolerability, they do not fully capture the patient experience. As a result, clinicians and patients may lack critical context for weighing the benefits and burdens of therapy.
“These findings underscore the urgent need for mandatory QoL reporting standards, enhanced journal enforcement policies, and transparent dissemination of patient-centered outcomes in GU cancer clinical trials,” Kalantri said.
The authors of the analysis recommend broader adoption of reporting guidelines, including CONSORT-PRO, to ensure that quality-of-life data are consistently collected and shared. They suggest that regulatory agencies and cooperative groups consider requiring publication of patient-centered outcomes as a condition of trial completion. Clear, consistent reporting would allow patients and clinicians to make more informed decisions, balancing clinical efficacy with real-world experience.
Key takeaways
Despite a strong trend toward including patient-centered measures in trial design, the reporting of quality-of-life outcomes in phase 3 GU trials remains incomplete. Positive trials are more likely to report these data, leaving gaps in understanding for negative or neutral studies. Comprehensive, transparent quality-of-life reporting is crucial for interpreting the full impact of cancer therapies on patients’ daily lives.
The analysis supports the need for standardized enforcement of reporting guidelines to ensure patient-reported outcomes are routinely communicated, providing critical context for both clinicians and patients.
References
“Evaluation of Quality of Life Endpoint Planning and Reporting in Phase IlI Genitourinary Oncology Randomized Controlled Trials,” by Dr. Shreyas Kalantri, et al. Journal of Clinical Oncology.
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