Trial assesses patient experience with at-home BCG treatment

In this video, recording at the 2025 Society of Urologic Oncology Annual Meeting in Phoenix, Arizona, Timothy D. Lyon, MD, an associate professor of urology and the Urology Residency Program Director at Mayo Clinic in Jacksonville, Florida, discusses the INVITE study.

INVITE is a 2-part clinical trial designed to evaluate the safety, feasibility, and patient experience of administering intravesical bladder cancer therapies in the home. The phase 1 pilot enrolled 10 patients, and the ongoing phase 2 cohort expansion will include 30 additional participants. Eligible patients receive induction or maintenance intravesical therapy with 1 of 4 regimens: BCG, gemcitabine, mitomycin, or sequential gemcitabine/docetaxel. All patients receive their first treatment dose in a traditional clinic to confirm tolerability and catheter placement. If successful, all subsequent doses are delivered in the patient’s home by a contracted home-care nursing network.

The trial’s primary end points are safety—defined by the incidence, nature, and severity of adverse events—and feasibility, measured by whether participants receive at least 5 of 6 planned induction doses or 2 of 3 maintenance doses within 12 weeks, with all intended home doses administered as planned. Key secondary end points include patient satisfaction, likelihood to recommend home-based treatment, treatment-related quality of life, 3- and 12-month disease-free survival, and time toxicity. Collectively, these metrics may help determine whether at-home intravesical therapy can reduce treatment burden while maintaining clinical standards.

Administering agents such as BCG in a home environment raises unique safety considerations, particularly around patient and data privacy. Because chemotherapy requires dual verification, the study uses a secure tablet-based video connection that allows the in-home nurse to complete verification with a second nurse located at the hospital. The system uses standard medical-grade encryption consistent with telemedicine platforms. Medication handling, PPE use, and waste disposal mirror hospital protocols, with waste collected by couriers for proper disposal. For BCG-specific precautions, patients are instructed to use a single toilet for 6 hours post-treatment and are provided bleach tablets to minimize any infection-transmission risk. Overall, these measures aim to ensure that home administration maintains the same safety standards as clinic-based care.