Home-Based Outpatient Model for BCG Delivery to Reduce Undue Burden on Patients Undergoing Treatment for Non-Muscle Invasive Bladder Carcinoma

Korábbi kezelés

• Current enrollment in another investigational drug or device study
• Previous severe adverse reaction or intolerance to BCG therapy

Más betegség

• History of intravesical Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma within the past 12 months
• Presence of serious systemic conditions or other active diseases (including severe lung disease) that, in the opinion of the investigator, would render the participant unsuitable for the study or compromise the evaluation of safety and tolerability of the study treatment
• History of complicated or traumatic urethral catheterization
• History of severe voiding dysfunction, uncontrolled urinary incontinence or any other condition that may impair adequate BCG dwell time
• Significant cognitive impairment or psychiatric disorder that may interfere with adherence to the study protocol

Laborértékek

• Immunocompromised state (e.g., HIV with CD4 count < 200 cells/mm\^3, solid organ transplant, or active immunosuppressive therapy)

Egyéb

• Pregnant or currently breastfeeding individuals

• At least 18 years of age at the time of enrollment
• Able and willing to provide signed informed consent, confirming voluntary participation and understanding of study-related information and procedures
• Determined by the investigator to be capable and willing to comply fully with the study protocol, including the independent or assisted completion of required questionnaires
• Pathological confirmation of NMIBC, with transurethral resection of bladder tumor (TURBT) completed within the past 6 weeks. In cases of cT1, the 6-week window may apply from the date of a second TURBT, if performed
• Clinically confirmed to be intermediate or high risk according to the American Urological Association (AUA)/Society of Urologic Oncology (SUO) risk stratification system:
  • Intermediate risk: recurrent low-grade Ta, solitary low-grade Ta > 3 cm, multifocal lowgrade Ta, low-grade T1, or high-grade Ta ≤ 3 cm.
  • High risk: any high-grade T1, recurrent high-grade Ta, high-grade Ta > 3 cm or multifocal, any carcinoma in situ (CIS), any BCG failure in a high-grade patient, any variant histology, lymphovascular invasion, or high-grade prostatic urethral involvement
• Decision to proceed with adjuvant intravesical Bacillus Calmette-Guérin (BCG) therapy
• No exposure to BCG within the previous year
• Subject agreement that their home:
  • is safe;
  • will permit a medical visitor to enter; and
  • has a private space free from pets and small children
• Ability to abstain from voiding for at least two hours
• Resides within the geographical service area of the affiliated home health service supporting the study
• Has reliable access to technology for remote video consultations or telephone communication, enabling necessary follow-up and safety monitoring