- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05810623
Single-Dose Intravesical Chemotherapy After Diagnostic URS (MINERVA)
Single-Dose Intravesical Instillation of Chemotherapy After Diagnostic/Therapeutic Flexible Ureteroscopy for Upper Tract Urothelial Carcinoma in the Prevention of Intravesical Recurrence: Prospective Randomized Multicenter Trial
Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC.
This study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation.
Study period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment.
Screening period: The period up to 28 days prior to intervention during which the screening procedures occur.
Treatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early.
Safety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments.
Survival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study.
Objectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC
Secondary objectives
- Time to intravesical recurrence
- 5-years intravesical recurrence rates
- Incidence of high-grade BCa recurrence
- Incidence and gravity of adverse events (AEs) due to the SI
- To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional)
- To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes/genetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional)
- To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation
- To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms
Target study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS
Duration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS.
Follow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS.
Survival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS.
Investigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability.
The selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator.
Statistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation.
Randomization will be stratified by the following factors:
- Center
- EAU UTUC risk stratification
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Shahrokh F Shariat, MD, Prof
- Phone Number: +4314040026150
- Email: shahrokh.shariat@meduniwien.ac.at
Study Contact Backup
- Name: David D'Andrea, MD
- Phone Number: +4314040026150
- Email: david.dandrea@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna
-
Contact:
- Shahrokh F Shariat, MD, Prof
- Phone Number: +4314040026150
- Email: shahrokh.shariat@meduniwien.ac.at
-
Contact:
- David D'Andrea, MD
- Phone Number: +4314040026150
- Email: david.dandrea@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subjects must meet all the following inclusion criteria to participate in this study:
- Age ≥ 18 years
- Diagnosis primary localized UTUC
- Imaging examinations show no distant metastasis
- Patients who agree to receive SI after URS for UTUC and will undergo the standard treatment, postoperative management, and follow-up in accordance with current guidelines
Exclusion Criteria:
- Any concurrent systemic therapy for any cancer
- Prior bladder cancer within 5 years
- Prior radical cystectomy
- Concomitant bladder cancer
- Bilateral UTUC
- Pregnancy
- Patient refused to participate
- Life expectancy of less than one year
- Solitary kidney
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SI Chemotherapy
Patients randomized to the experimental arm will receive a SI within 24h after diagnostic URS.
In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS.
|
Intravesical single dose instillation of chemotherapy within 24h from uretero-renoscopy
|
No Intervention: Observation
Patient randomized to the observational arm will be treated and followed according to institutional own standards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of a SI in the prophylaxis of intravesical recurrence after URS for UTUC
Time Frame: 2 years
|
Proportion of patients free of intravesical recurrence at 2-years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to intravesical recurrence
Time Frame: 5 years
|
Time to first occurrence of an bladder tumor after URS for UTUC
|
5 years
|
5-years intravesical recurrence rates
Time Frame: 5 years
|
Proportion of patients free of intravesical recurrence at 5-years
|
5 years
|
Incidence of high-grade BCa recurrence
Time Frame: 5 years
|
Proportion of patients HG with intravesical recurrence at 5 years
|
5 years
|
Incidence and gravity of adverse events (AEs) due to the SI
Time Frame: 2 months
|
Proportion of patients experiencing an AE
|
2 months
|
Biobanking
Time Frame: 10 years
|
To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit
|
10 years
|
Genetic mutation analysis
Time Frame: 3 years
|
Prevalence of lynch syndrome
|
3 years
|
To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation
Time Frame: 2 years
|
2 years
|
|
To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2411-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bladder Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Cancer | Urinary Complications | Stage 0 Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder Cancer
-
Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
-
Taris Biomedical LLCBristol-Myers SquibbTerminatedBladder Cancer TNM Staging Primary Tumor (T) T2 | Bladder Cancer TNM Staging Primary Tumor (T) T2A | Bladder Cancer TNM Staging Primary Tumor (T) T2B | Bladder Cancer TNM Staging Primary Tumor (T) T3 | Bladder Cancer TNM Staging Primary Tumor (T) T3A | Bladder Cancer TNM Staging Primary Tumor... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
Clinical Trials on Intravesical Solution
-
Dokuz Eylul UniversityNot yet recruitingBladder Cancer | Gemcitabine | BCG | Docetaxel | Intravesical InstillationTurkey
-
Henan Cancer HospitalRecruitingIntraoperative Complications | Perfusion; Complications | High-Risk, Non-Muscle Invasive Bladder Urothelial CarcinomaChina
-
Rennes University HospitalCompletedIntensive Care Unit SyndromeFrance
-
National Taiwan University HospitalTerminated
-
Anhembi Morumbi UniversityActive, not recruitingBladder Pain Syndrome | Interstitial Cystitis, ChronicBrazil
-
UroGen Pharma Ltd.RecruitingBladder Cancer | Non-muscle Invasive Bladder Cancer | Urothelial Carcinoma Bladder | NMIBC | Urothelial Carcinoma Recurrent | Carcinoma in Situ of BladderUnited States, Italy, Spain
-
The University of Western AustraliaRoyal Perth Hospital; Fiona Stanley Hospital; Perth Urology ClinicCompletedSpinal Cord InjuriesAustralia
-
Loma Linda UniversityCompletedUrinary Bladder, Overactive | Urinary Incontinence, UrgeUnited States
-
Michael Zell, MDNot yet recruitingOveractive Bladder | Benign Prostatic HyperplasiaUnited States
-
Ankara Training and Research HospitalCompletedDisease Progression | Bladder Cancer | Recurrent Bladder Cancer