Upper Urinary Tract Urothelial CarcinomaPhase 3MINERVANCT05810623
Single-Dose Intravesical Chemotherapy After Diagnostic URS
A Phase 3 study testing Intravesical Solution in people with Upper Urinary Tract Urothelial Carcinoma and Bladder Cancer, run by David D'Andrea at 2 sites in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Urinary Tract Urothelial Carcinoma, Bladder Cancer
- What is being tested?
- Intravesical Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jun 2023to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any concurrent systemic therapy for any cancer
- Prior bladder cancer within 5 years
- Prior radical cystectomy
- Concomitant bladder cancer
- Bilateral UTUC
- Pregnancy
Show all 9Show fewer
- Patient refused to participate
- Life expectancy of less than one year
- Solitary kidney
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites
Medical University of Vienna
Vienna, 1090
Shahrokh F Shariat, MD, Prof, +4314040026150, shahrokh.shariat@meduniwien.ac.at
David D'Andrea, MD, +4314040026150, david.dandrea@meduniwien.ac.at
Medical University of Vienna
Vienna, 1090
About this study
Official title: 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.
Read more
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
- Being tested
- Intravesical Solution
- Keywords
- UTUC, intravesical chemotherapy, bladder cancer, recurrence
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical SolutionDrug
Intravesical single dose instillation of chemotherapy within 24h from uretero-renoscopy
| Study group | Role | What they receive |
|---|---|---|
| SI Chemotherapy | Experimental | 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. Receives: Drug: Intravesical Solution |
| Observation | No intervention | Patient randomized to the observational arm will be treated and followed according to institutional own standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a SI in the prophylaxis of intravesical recurrence after URS for UTUC
Proportion of patients free of intravesical recurrence at 2-years
Measured: 2 years
Secondary outcomes (8)
Time to intravesical recurrence
Time to first occurrence of an bladder tumor after URS for UTUC
Measured: 5 years
5-years intravesical recurrence rates
Proportion of patients free of intravesical recurrence at 5-years
Measured: 5 years
Incidence of high-grade BCa recurrence
Proportion of patients HG with intravesical recurrence at 5 years
Measured: 5 years
Incidence and gravity of adverse events (AEs) due to the SI
Proportion of patients experiencing an AE
Measured: 2 months
Biobanking
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
Measured: 10 years
Genetic mutation analysis
Prevalence of lynch syndrome
Measured: 3 years
To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation
Measured: 2 years
To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David D'Andrea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David D'Andrea, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810623
- Sponsor's protocol ID
- 2411-2021
- Acronym
- MINERVA
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with other researchers once the trial will be completed. Project proposals must be submitted to the international coordinator committee for review
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05810623
- Acronym / sponsor ID
- MINERVA / 2411-2021
- Keywords
- UTUC, intravesical chemotherapy, bladder cancer, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- David D'AndreaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SI Chemotherapy | Experimental | Drug: Intravesical SolutionPatients 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. |
| Observation | No intervention | –Patient randomized to the observational arm will be treated and followed according to institutional own standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Any concurrent systemic therapy for any cancer
- Prior bladder cancer within 5 years
- Prior radical cystectomy
- Concomitant bladder cancer
- Bilateral UTUC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical SolutionIntravesical single dose instillation of chemotherapy within 24h from uretero-renoscopy | Drug | SI Chemotherapy |
Primary outcome
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
8 secondary outcomes
Time to intravesical recurrence
Time frame: 5 years
5-years intravesical recurrence rates
Time frame: 5 years
Incidence of high-grade BCa recurrence
Time frame: 5 years
Incidence and gravity of adverse events (AEs) due to the SI
Time frame: 2 months
Biobanking
Time frame: 10 years
Genetic mutation analysis
Time frame: 3 years
To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation
Time frame: 2 years
To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. IPD will be shared with other researchers once the trial will be completed. Project proposals must be submitted to the international coordinator committee for review
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravesical Solution in people with Upper Urinary Tract Urothelial Carcinoma and Bladder Cancer, run by David D'Andrea at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahrokh F Shariat, MD, Prof (+4314040026150, shahrokh.shariat@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a SI in the prophylaxis of intravesical recurrence after URS for UTUC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.