Using Pseudomonas aeruginosa to treat non-muscle invasive bladder cancer

Efficacy and Safety of Pseudomonas Aeruginosa Followed by Postoperative Intravesical Instillation in Patients With Intermediate and High-risk Non-muscle Invasive Bladder Cancer: a Multi-center, Single-arm Clinical Study

This study is testing if using Pseudomonas aeruginosa along with chemotherapy can help people with intermediate and high-risk non-muscle invasive bladder cancer feel better after their surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05975151 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm study aims to evaluate the efficacy and safety of Pseudomonas aeruginosa in patients with intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). A total of 63 subjects will receive submucosal injections of Pseudomonas aeruginosa and chemotherapy drugs immediately after undergoing transurethral resection of bladder tumor (TURBT). The treatment regimen includes weekly injections for 12 weeks followed by monthly treatments for a year, with follow-ups every three months post-surgery. The study is designed to assess clinical benefits and monitor for any intolerable side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with intermediate or high-risk non-muscle invasive bladder cancer.

Not a fit: Patients currently receiving BCG or other immune drug infusion chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with intermediate and high-risk NMIBC, potentially improving their outcomes.

How similar studies have performed: While similar approaches have been explored, this specific use of Pseudomonas aeruginosa in NMIBC is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion criteria:

1. Age ≥18 years old, both male and female;
2. Diagnosed as Intermediate or high risk non-muscle invasive bladder cancer, with previous recurrent pathological diagnosis report and cystoscopy available. Intermediate risk was defined as the presence of one or two of the following: multiple tumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBC within 1 year after diagnosis). High risk was defined as meeting any one of the following: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large (\> 3cm) TaG1G2/ low-risk tumor (simultaneous);
3. Not receiving BCG or other immune drug infusion chemotherapy at the same time
4. Informed consent and signed informed consent form by patients and their families;
5. Clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves;
6. No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed.

Exclusion criteria:

1. Patients with other genitourinary system tumors or other organ tumors;
2. Patients with muscle invasive bladder urothelial carcinoma (≥T2);
3. Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy);
4. Pregnant or lactating women, women of childbearing age who did not use effective contraception, and those who planned to become pregnant during the trial (including the partner of male subjects);
5. Known or suspected intraoperative bladder perforation;
6. Gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa;
7. Patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study;
8. Patients who had participated in a clinical trial with other drugs within 3 months before enrollment;
9. Patients with known opioid or alcohol dependence;
10. Patients with any condition considered by the investigators to increase the risk of the subject or interfere with the conduct of the trial;

Where this trial is running

Jinan, Shandong

• Qilu hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Benkang Shi, Dr.

Conditions: Bladder Cancer, bladder cancer, NMIBC, Pseudomonas aeruginosa