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INVITE Trial: In-Home Bladder Cancer Treatment

This study, called the INVITE Trial, is looking at whether certain bladder cancer treatments can be given safely and effectively at home. These treatments, including BCG, gemcitabine, and docetaxel, are usually given directly into the bladder (intravesical chemotherapy) in a clinic. The study aims to see if giving these treatments at home, with support from home health visits, is a good option for patients with non-muscle invasive bladder cancer (stages 0a, 0is, or I). Researchers will be tracking any side effects and how practical it is to give these treatments at home over 12 weeks. You may be able to join if you are an adult with this type of bladder cancer and are currently receiving one of the listed intravesical treatments.

Study design
This is a Phase Ib/II interventional study with a planned enrollment of 40 participants. It compares the safety and feasibility of in-home versus in-clinic delivery of bladder cancer treatments.
What's involved
Participants will receive their intravesical treatment (BCG, gemcitabine, gemcitabine/docetaxel, or mitomycin C) weekly at home for up to 5 weeks. You will also undergo cystoscopy (a procedure to look inside the bladder).
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, including side effects and feasibility, will be measured at 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06704191

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~40 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:BCG SolutionCystoscopyDocetaxelGemcitabineHome Health EncounterMitomycin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs)
Measured over 12 weeks
+1 more outcome measured

Conditions

Non-Muscle Invasive Bladder Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8

Explore related trials

Bladder Carcinoma

NCT06704191

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Timothy D. Lyon, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

PHASE IB ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens
Gemcitabine
Sequential gemcitabine/docetaxel
Bacillus Calmette-Guerin
Mitomycin C
PHASE II ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis or T1) who are receiving maintenance therapy with an eligible regimen
PHASE IB ONLY: Able to be successfully catheterized and able to tolerate first dost of intravesical therapy in the outpatient clinic
Residing within the area serviced by supplier network
Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits
Age ≥ 18 years at time of registration
Signed informed consent form by patient
Willing and able to comply with the study protocol in the investigator's judgment
Ability to complete questionnaire(s) by themselves or with assistance
Willingness to follow birth control requirements for females and males of reproductive potential

Exclusion

Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens
Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
Requiring 24/7 assistance with activities of daily living (ADLs)
Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Myocardial infarction ≤ 6 months
Wound healing disorder
Psychiatric illness/social situations that would limit compliance with study requirements
Anticipation of the need for major surgery during the course of study treatment
Known allergy or previous intolerance to drug regimens
Pregnancy or breastfeeding
Hypersensitivity or allergy to polysorbate 80 or paclitaxel

What this trial measures

  • Incidence and severity of adverse events (AEs)12 weeks

    The incidence, type, and severity of AEs experienced will be reported. The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Feasibility of in-home intravesical therapy12 weeks

    Feasibility will be indicated by the proportion of patients who receive at least 4 of 5 planned doses of induction therapy in the home within 12 weeks of the first dose of intravesical therapy (received in the outpatient clinic).