Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk 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 is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive bladder cancer. The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: Pseudomonas aeruginosa

Detailed Description

This study used a multicenter open single-arm study design. Study start: March 2023 Study end: March 2024 Multi-center: Three centers were selected to conduct the study to avoid differences in efficacy due to differences in operation among centers. Single-arm study: A total of 63 subjects with intermediate-high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Benkang Shi, Dr.; Phone Number: 18560083917; Email: bkang68@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 276600
      • Recruiting
      • Qilu hospital
      • Contact: Benkang Shi; Phone Number: bkang68@sdu.edu.cn; Email: bkang68@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pseudomonas aeruginosa Group

Drug: Pseudomonas aeruginosa; A total of 63 subjects with intermediate and high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate	Recurrence rate is determined on the basis of cystoscopy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Disease-free survival is defined as the time from the start of study treatment to disease recurrence or death from any cause	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event	Adverse events including lower urinary tract symptoms, fever, and gastrointestinal reactions were evaluated according to laboratory and clinical tests (i.e., hematology and blood chemistry, urinalysis, and vital signs) during the observation period	2 year

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: bladder cancer; NMIBC; Pseudomonas aeruginosa
• Additional Relevant MeSH Terms: Infections; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Pseudomonas Infections; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: bks02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No