Bladder (Urothelial, Transitional Cell) CancerPhase 3TEMPO-MIBCNCT07067749
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
A Phase 3 study testing multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt) and Circulating tumour DNA levels assessment in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder Cancer Requiring Cystectomy, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma
- What is being tested?
- multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt) and Circulating tumour DNA levels assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 15 Aug 2025to 15 Aug 2030
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging
Who cannot join
- Anticipated survival < 3 months due to comorbidities
- Pregnant patients
- Breastfeeding patients
- Previous chemotherapy within 6 weeks
- Previous radiotherapy withing 6 weeks
- Previous TURBt within 6 weeks
Show all 10Show fewer
- Severe renal impairment (eGFR < 40 mL/min/1.73 m2)
- non MRI-compatible metal implants
- Claustrophobia
- Denial of written consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luca Orecchia, MD contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata
Rome, RM, 00133
Simone Albisinni, Associate Professor of Urology, 06020902977, simone.albisinni@ptvonline.it
Luca Orecchia, Consultant Urologist
About this study
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.
A blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm, Muscle Invasive Bladder Cancer (MIBC)
- Being tested
- multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt), Circulating tumour DNA levels assessment
- Keywords
- Muscle Invasive Bladder Cancer, VI-RADS, Bladder Magnetic Resonance Imaging, Cystectomy, TURBT, treatment expedition, cancer management optimisation, circulating tumour DNA
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric magnetic resonance imaging (mpMRI) of the bladderDiagnostic test
This study will investigate the role of bladder mpMRI as a tool to expedite treatment in patients with muscle invasive bladder cancer.
mpMRIs will be investigated as a possible replacement of standard TURBt, a planned surgical procedure for cancer local staging.
mpMRis will be reported according to the Vesical Imaging - Reporting and Data System Stanrdars (VI-RADS) to provide a score indicating probability of muscle invasion.
Transurethral resection of bladder tumour (TURBt)Procedure or surgery
This is a planned endoscopic surgical procedure consisting in resection of the bladder tumour through a electrified loop manouvred with an endoscope. In muscle invasive bladder cancer, this procedure allows histological confirmation of presence of detrusor muscle invasion.
Circulating tumour DNA levels assessmentGenetic
Blood samples will be collected from each enrolled patient at pre-planned time points:
- Cystoscopy, both arms
- mpMRI (experimental arm) or TURBt (control arm)
- Definite cancer treatment, both arms ctDNA levels will be measured on the collected blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Standard Management | Active comparator | Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for TURBt and be managed according to international guidelines.
If the pathology report of the TURBt will show muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT. Receives: Procedure: Transurethral resection of bladder tumour (TURBt); Genetic: Circulating tumour DNA levels assessment |
| Simplified Management | Experimental | Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for bladder mpMRI through a dedicated service at the sponsor Institution to assess the suspiscion detrusor muscle invasion by the tumour.
If the pathology report of the biopsy will show cancer and the mpMRI will confirm a high degree of suspicion for muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT. Receives: Diagnostic Test: multiparametric magnetic resonance imaging (mpMRI) of the bladder; Genetic: Circulating tumour DNA levels assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to definitive treatment
Time in days needed to complete the diagnostic pathway, multidisciplinary board discussion and finally offer the appropriate definitive treatment for muscle invasive bladder cancer: surgery, drugs, radiation, palliative care
Measured: From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.
Secondary outcomes (5)
Concentration of ctDNA levels
ctDNA leves from blood samples collected at pre-planned time points in both arms
Measured: Three specific time points: 1) Enrolment at baseline 2) During intervention (mpMRI or TURBt) 3) On the day of definitive treatment for muscle invasive cancer Expected timeframe 1 to 180 days
Cancer Specific Survival
Length of time from enrolment to the date of death from the disease.
Measured: through study completion, an average of 2 years
Overall Survival
Length of time from enrolment to the date of death from any cause
Measured: through study completion, an average of 2 years
Time to cancer recurrence
Length of time from enrolment to the date of clinically proven cancer recurrence
Measured: "through study completion, an average of 2 years".
Number of procedure Related Complications
Monitoring of procedure related complications for TURBt and mpMRI
Measured: For 30 days following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, parallel, two-arm randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Albisinni, University of Rome Tor Vergata
- Investigators
- Simone Albisinni, MD, Phd, FEBU, Principal investigator, Fondazione PTV Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067749
- Sponsor's protocol ID
- 315.24CET2 ptv
- Acronym
- TEMPO-MIBC
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data to be released to other parties upon reasonable request to the Principal Investigatorand Local Ethics Board approval
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07067749
- Acronym / sponsor ID
- TEMPO-MIBC / 315.24CET2 ptv
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm, Muscle Invasive Bladder Cancer (MIBC)
- Keywords
- Muscle Invasive Bladder Cancer, VI-RADS, Bladder Magnetic Resonance Imaging, Cystectomy, TURBT, treatment expedition, cancer management optimisation, circulating tumour DNA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 16 Jul 2025 (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.
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.
A blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre, parallel, two-arm randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Management | Active comparator | Procedure: Transurethral resection of bladder tumour (TURBt), Genetic: Circulating tumour DNA levels assessmentPatients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution. They will be booked for TURBt and be managed according to international guidelines. If the pathology report of the TURBt will show muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment. Treatment will be discussed with patients in a shared decision making context and booked. Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT. |
| Simplified Management | Experimental | Diagnostic Test: multiparametric magnetic resonance imaging (mpMRI) of the bladder, Genetic: Circulating tumour DNA levels assessmentPatients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution. They will be booked for bladder mpMRI through a dedicated service at the sponsor Institution to assess the suspiscion detrusor muscle invasion by the tumour. If the pathology report of the biopsy will show cancer and the mpMRI will confirm a high degree of suspicion for muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment. Treatment will be discussed with patients in a shared decision making context and booked. Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging
Key exclusion criteria (10 listed)
- Anticipated survival < 3 months due to comorbidities
- Pregnant patients
- Breastfeeding patients
- Previous chemotherapy within 6 weeks
- Previous radiotherapy withing 6 weeks
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 |
|---|---|---|
| multiparametric magnetic resonance imaging (mpMRI) of the bladderThis study will investigate the role of bladder mpMRI as a tool to expedite treatment in patients with muscle invasive bladder cancer. mpMRIs will be investigated as a possible replacement of standard TURBt, a planned surgical procedure for cancer local staging. mpMRis will be reported according to the Vesical Imaging - Reporting and Data System Stanrdars (VI-RADS) to provide a score indicating probability of muscle invasion. | Diagnostic test | Simplified Management |
| Transurethral resection of bladder tumour (TURBt)This is a planned endoscopic surgical procedure consisting in resection of the bladder tumour through a electrified loop manouvred with an endoscope. In muscle invasive bladder cancer, this procedure allows histological confirmation of presence of detrusor muscle invasion. | Procedure or surgery | Standard Management |
| Circulating tumour DNA levels assessmentBlood samples will be collected from each enrolled patient at pre-planned time points: 1. Cystoscopy, both arms 2. mpMRI (experimental arm) or TURBt (control arm) 3. Definite cancer treatment, both arms ctDNA levels will be measured on the collected blood samples. | Genetic | Simplified Management, Standard Management |
Primary outcome
Time to definitive treatment
Time frame: From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.
Time in days needed to complete the diagnostic pathway, multidisciplinary board discussion and finally offer the appropriate definitive treatment for muscle invasive bladder cancer: surgery, drugs, radiation, palliative care
5 secondary outcomes
Concentration of ctDNA levels
Time frame: Three specific time points: 1) Enrolment at baseline 2) During intervention (mpMRI or TURBt) 3) On the day of definitive treatment for muscle invasive cancer Expected timeframe 1 to 180 days
Cancer Specific Survival
Time frame: through study completion, an average of 2 years
Overall Survival
Time frame: through study completion, an average of 2 years
Time to cancer recurrence
Time frame: "through study completion, an average of 2 years".
Number of procedure Related Complications
Time frame: For 30 days following the procedure
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 24 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual patient data to be released to other parties upon reasonable request to the Principal Investigatorand Local Ethics Board approval
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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.
Luca Orecchia, MD contact
Simone Albisinni, MD, Phd, FEBU principal investigator
Fondazione PTV Policlinico Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt) and Circulating tumour DNA levels assessment in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder Cancer Requiring Cystectomy, run by University of Rome Tor Vergata at 1 site in Italy.
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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Simone Albisinni, MD, Phd, FEBU (+390620902977, simone.albisinni@ptvonline.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to definitive treatment (time frame: From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.). 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 24 Jul 2025.