Age and Bladder Cancer Outcomes After BCG Treatment: A Multicenter Study

NCT07798479 | Completed

• 1 other identifier: 6096
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates whether a patient's age affects the outcomes of Bacillus Calmette-Guérin (BCG) treatment for high-grade bladder cancer. Bladder cancer is a common cancer that can sometimes grow into the deeper layers of the bladder wall. In this study, we focus on patients with primary pT1 high-grade bladder cancer, a form of bladder cancer with a higher risk of coming back or progressing. Standard treatment includes removal of the tumor through the urethra (transurethral resection), a second procedure to check that no tumor remains, and treatment with BCG, which is given directly into the bladder to reduce the risk of the cancer returning or progressing. Current treatment recommendations do not change BCG treatment based on a patient's age. However, some previous studies have suggested that BCG may be less effective in older patients. Because the number of older adults with bladder cancer is increasing, it is important to understand whether age should influence treatment decisions. This is a retrospective multicenter cohort study. Researchers will review medical records of patients with primary pT1 high-grade bladder cancer who underwent transurethral resection, repeat resection showing no remaining tumor, and BCG treatment according to current European Association of Urology (EAU) recommendations. The study will compare cancer outcomes between different age groups. The main outcomes of interest are: Recurrence-free survival: how long patients remain free from a return of bladder cancer. Progression-free survival: how long patients remain free from worsening or more advanced bladder cancer. Overall survival: how long patients remain alive after treatment. The study includes 64 patients, with a median follow-up period of 43 months. Patients were compared using age thresholds of 70 and 75 years. The results showed no significant difference in the risk of cancer recurrence or progression between younger and older patients based on these age thresholds. Other tumor and patient characteristics may influence outcomes. In this study, carcinoma in situ and very high-risk tumors were associated with a higher risk of progression in some analyses, while female sex was associated with a higher risk of recurrence and progression in multivariable analyses. Overall, the findings suggest that age alone may not be associated with worse cancer outcomes after BCG treatment for primary pT1 high-grade bladder cancer. Therefore, older age by itself should not necessarily be a reason to withhold BCG treatment. Treatment decisions should be individualized and take into account the patient's overall health, tumor characteristics, treatment tolerance, and preferences. This study is retrospective, meaning that researchers analyze information that has already been collected during routine medical care. It does not assign patients to different treatments.

Conditions

Bladder Cancer; NMIBC

Keywords

bladder cancer; NMIBC; BCG therapy; age; immunosenescence; recurrence; progression

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  Time from initial transurethral resection to first documented bladder cancer recurrence or last follow-up.

  From date of initial transurethral resection (Day 1) until first documented recurrence or last follow-up, assessed retrospectively up to 69 months.

Secondary Outcomes (2)

• Progression-free survival

  From date of initial transurethral resection (Day 1) until first documented disease progression or last follow-up, assessed retrospectively up to 69 months.

• Overall survival

  From date of initial transurethral resection (Day 1) until death from any cause or last follow-up, assessed retrospectively up to 69 months.

Interventions

Intravesical Bcg DRUG

This is a retrospective observational study with no assigned study intervention. Patients received standard-of-care Bacillus Calmette-Guérin (BCG) therapy for primary pT1 high-grade bladder cancer as part of routine clinical care, following transurethral resection and repeat resection confirming no residual tumor. BCG was administered intravesically according to current European Association of Urology (EAU) recommendations. The study does not compare different BCG preparations, doses, or treatment schedules. Instead, it evaluates whether patient age is associated with recurrence-free survival, progression-free survival, and overall survival after standard BCG treatment. No experimental treatment or change in clinical management is performed as part of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with primary pT1 high-grade urothelial bladder cancer who underwent transurethral resection of the bladder tumor, followed by repeat resection confirming no residual tumor, and subsequently received intravesical BCG therapy according to current EAU guidelines. The retrospective multicenter cohort includes 64 patients. Patients are evaluated according to age, with comparisons using age thresholds of 70 and 75 years. The study population includes both male and female patients and represents patients treated with standard-of-care BCG therapy in routine clinical practice.

You may qualify if:

• Treatment: TUR-B + Re-TUR-B + BCG (≥6 instillations)

You may not qualify if:

• Re-TUR-B \> 56 after TUR-B
• Residual tumor on re-TUR-B histology
• non-urothelial histology

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Recurrence; Disease Progression

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: March 1, 2009
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 1, 2026

Record last verified: 2026-08