(UroToday.com) The American Urological Association's 2025 Annual Meeting, between April 26 – 29, 2025, in Las Vegas, Nevada, was host to the Plenary Session: Paradigm-Shifting, Practice-Changing Clinical Trials in Urology. Dr. John Gore discussed Radical cystectomy versus bladder-sparing therapy for recurrent high-grade non-muscle invasive bladder cancer: Results from the Comparison of Intravesical Therapy and Surgery as Treatment (CISTO) Study.
Dr. Gore began his presentation by highlighting several unmet needs in non–non-muscle-invasive bladder cancer (NMIBC), as identified by the BCAN Patient Survey Network, which included responses from 591 patients with NMIBC. Key questions raised by patients and providers included: How can decisions be made about the need for radical cystectomy, and what is the optimal timing? What are the best treatment options for patients whose cancer recurs or worsens following BCG therapy?
To date, there remains very limited evidence to guide the management of recurrent high-grade NMIBC, leading to significant uncertainty for both patients and clinicians. In response, investigators designed and launched the CISTO study—a prospective trial comparing radical cystectomy with bladder-sparing therapy in this patient population. Notably, CISTO is the only ongoing prospective study that includes radical cystectomy as a comparator to bladder-sparing treatment strategies.
CISTO was a prospective observational cohort study designed to compare health-related quality of life (QOL) and clinical outcomes in patients with recurrent high-grade NMIBC. The investigators hypothesized that patients undergoing radical cystectomy would experience worse health-related QOL at 12 months compared to those who chose bladder-sparing therapy. Targeted maximum likelihood estimation was used for the analysis. The study enrolled patients who were eligible for both treatment approaches and collected patient-reported and clinical outcomes at baseline, 3, 6, 9, and 12 months. The study was conducted across 36 university-based and community sites, reflecting a broad and diverse clinical practice setting.
The primary outcome was physical functioning, assessed using the EORTC QLQ-C30 questionnaire. Secondary key endpoints included generic quality of life, emotional well-being, and financial well-being, also measured with the EORTC QLQ-C30. Urinary, sexual, and bowel function were evaluated using the Bladder Cancer Index. Additionally, survival outcomes were estimated as part of the study's comprehensive assessment.
Dr. Gore highlighted that patient characteristic were overall well balanced, apart from age for which the BST group was older (72.4 vs. 69.6 years), urban residence status and clinical stage at enrollment, with more patients having T1 stage in the RC group (57% vs. 30%) as shown in the table below.
In terms of general quality of life, results across three questionnaires: EORTC Physical Functioning, EORTC Global Health, and EQ-5D—all appeared to favor radical cystectomy over bladder-sparing therapy.
Similarly, both emotional well-being outcomes assessed across all domains (EORTC Emotional Functioning, PROMIS Depression, and PROMIS Anxiety), and financial well-being outcomes on both domains (EORTC Financial Difficulties and the COST Financial Toxicity) significantly favored radical cystectomy over bladder-sparing therapy.
In terms of longitudinal physical functioning both in the overall cohort and among patients aged ≥75 years there was a noticeable decline at month 3 in the radical cystectomy group. However, functioning returned to baseline levels by month 6 and was even higher than in the bladder-sparing therapy group among older patients.
Moreover, in the longitudinal assessment of urinary health, patients in the BST group maintained relatively stable scores over the 12-month period, with a slight improvement. In contrast, those in the RC group showed a gradual increase in urinary health scores, indicating a progressive improvement in urinary function over time.
Notably, sexual health took a significant hit in the RC group at month 3 and, while it remained lower than in the BST group, it showed gradual recovery over time. Regarding bowel function, as measured by the BCI bowel score, there was a slight decline in the RC group at month 3 compared to the BST group; however, this returned almost to baseline levels by month 6.
Lastly, the 12-month bladder cancer–specific survival was comparable between groups, with 99% in the BST group and 96% in the RC group (adjusted risk ratio 0.98, 95% CI: 0.96–1.01). Notably, 27 participants (8.1%) initially treated with BST underwent RC within 12 months—21 (6.3%) due to recurrence and 4 (1.2%) due to progression.
Dr. Gore summarized the 12-month outcomes in the table below, highlighting key differences between treatment groups. Bowel and sexual health, as well as progression-free survival, tended to favor bladder-sparing therapy. However, physical functioning (in patients with CIS and unpartnered), cognitive functioning, mental, and financial health scores as well as recurrence-free survival favored radical cystectomy.
Dr. Gore concluded his presentation with the following key takeaways:
- Radical cystectomy remains an important treatment option in the management of recurrent high-grade NMIBC.
- At 12 months, physical function was comparable between patients who underwent bladder-sparing therapy and those treated with radical cystectomy.
- Secondary outcomes, including global health, anxiety, depression, and financial well-being, were more favorable among patients who received radical cystectomy.
- Continued funding will allow for the collection of longer-term patient-reported and clinical outcomes.
Presented by: John L. Gore, MD, MS, FACS, Professor, Department of Urology; Adjunct Professor, Department of Surgery, University of Washington School of Medicine, Seattle, WA.
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the American Urological Association's 2025 Annual Meeting, between April 26 – 29, 2025, in Las Vegas, NV.
Related content: CISTO Study: Comparing Cystectomy vs. Bladder-Sparing Therapy for Recurrent NMIBC - John Gore