MITOMYCIN for Non-muscle invasive bladder cancer

Inclusion criteria

• {"criterion_text":"-Patients older than 18 years and life expectancy ≥ 5 years."}
• {"criterion_text":"-Patients able to give informed consent for the study."}
• {"criterion_text":"-Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3."}
• {"criterion_text":"-Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks."}
• {"criterion_text":"-Negative bladder random biopsies for Tcis"}
• {"criterion_text":"-Presence of own muscle in the TUR and / or in the RE-RTU."}
• {"criterion_text":"-RE-RTU in all cases of T1 and also in Ta tumors when the initial TUR is incomplete or with absence of muscle in the sample."}

Exclusion criteria

• {"criterion_text":"-Patients unable to give informed consent for their participation in the study."}
• {"criterion_text":"-Stage tumors ≥T2."}
• {"criterion_text":"-cN + and / or cM + tumors."}
• {"criterion_text":"-Pregnant women."}
• {"criterion_text":"-Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection"}
• {"criterion_text":"-Patients with a history of allergic reactions to BCG or MMC."}
• {"criterion_text":"-Patients with pacemakers or DICs"}
• {"criterion_text":"-Previous history of bladder tumors."}
• {"criterion_text":"-Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus)."}
• {"criterion_text":"-Absence of own muscle in the sample (neither in RTU nor in RE-RTU)."}
• {"criterion_text":"-Patients with stage T1 who have not received RE-RTU."}
• {"criterion_text":"-Patients with Tcis isolated or associated with papillary tumor."}
• {"criterion_text":"-Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma"}

Primary endpoints

• {"endpoint_text":"-5-year tumor recurrence rate. Defined as the percentage of pathologically confirmed urothelial carcinoma recurrences following transurethral resection (TUR) or biopsy, after a specified period of time during which the patient has remained disease-free. Recurrence rates will be compared between the two study groups.","definition_or_measurement_approach":"Defined as the percentage of pathologically confirmed urothelial carcinoma recurrences following transurethral resection (TUR) or biopsy, after a specified period of time during which the patient has remained disease-free. Recurrence rates will be compared between the two study groups."}

Secondary endpoints

• {"endpoint_text":"-Disease-free survival (DFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"-Tumor progression rate, defined as the percentage of patients who develop stage ≥ T2 disease.","definition_or_measurement_approach":"Defined as the percentage of patients who develop stage ≥ T2 disease."}
• {"endpoint_text":"-Tumor progression-free survival (PFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"-Overall survival.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Adjuvant treatment completion rate.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Cost-effectiveness evaluation of the use of the developed model for the follow-up of patients with high-grade NMIBC treated with adjuvant BCG or EMDA-MMC","definition_or_measurement_approach":""}
• {"endpoint_text":"-Prospective and detailed recording of adverse events (AEs) and serious adverse events (SAEs).","definition_or_measurement_approach":""}
• {"endpoint_text":"-Impact of adjuvant treatment on patient quality of life (FACT-BL, HADs, and Distress Thermometer).","definition_or_measurement_approach":"Quality of life measured using FACT-BL, HADs, and Distress Thermometer instruments."}

Spain

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

09-10-2025

Processing Time Days

293

Number Of Sites

20

Number Of Participants

230

Primary sponsor

Full Name

Presurgy S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Fundacion Instituto Valenciano De Oncologia","duties_or_roles":"sponsorDuties code 4","organisation_type":"Hospital/Clinic/Other health care facility"}