The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer - FUTURE Trial (FUTURE)

The Combined Role of FAPI PET and Liquid Biopsy in the Staging and Clinical Management of Bladder Cancer

The study will be a prospective two arms diagnostic phase II single-center trial.

Patients referred for diagnosis and treatment with diagnosis of bladder cancer, age > 18 years, ECOG performance status < 2, ability to undergo an imaging study procedure will be considered for inclusion. For the study will be include 262 patients (118 and 144 in the arm 1 and 2, respectively).

Eligible patients will sign the inform consent to be included in the study. The participation to other clinical studies will be not, per se, an exclusion criterion. Before treatment, enrolled patients will be imaged by FAPI PET/CT and urine samples will be collected and analyzed by Epicheck® test and Xpert® Bladder Cancer Detection. Thereafter, patients will be managed and treated according to international guidelines and standard of care procedures in our institution. Safety will be recorded. Results of FAPI imaging, Epicheck® test, and Xpert® Bladder Cancer Detection will be compared to stage, risk assessment groups as defined by currentguidelines, and clinical outcome. Diagnostic and predictive performances of FAPI imaging and liquid biopsy will be assessed and compared by using machine learning approaches.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy; Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment

• Study Type: Interventional
• Enrollment (Estimated): 262
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Martina Sollini; Phone Number: 0226436319; Email: sollini.martina@hsr.it
• Study Contact Backup: Name: Chiara Catalano; Email: catalano.chiara@hsr.it

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• age > 18 years
• ECOG performance status < 2
• ability to undergo an imaging study procedure

Exclusion Criteria:

• pregnant or breast-feeding women
• uncontrolled active infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BC patients eligible for radical cystectomy; BC patients treated with radical cystectomy ± neoadjuvant therapy	Procedure: FAPI PET/CT and liquid biopsy in patients eligible for radical cystectomy; We hypothesise that FAPI PET improves clinical staging, and that baseline FAPI PET metrics and ctDNA/utDNA profiles correlate with tumour aggressiveness and patient outcomes
Experimental: BC patients treated with systemic therapy; patients eligible for conservative treatment	Procedure: FAPI PET/CT and liquid biopsy in patients eligible for conservative treatment; We hypothesise that FAPI PET improves clinical staging, and that baseline FAPI PET metrics and ctDNA/utDNA profiles correlate with tumour aggressiveness and patient outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of FAPI PET/CT for the detection in the Staging of Bladder Cancer	Sensitivity will be calculated as the proportion of true positive findings obtained with FAPI PET/CT compared with the reference standard (e.g., clinical follow-up).	from enrollment to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET Imaging	secondary outcome aims to image patients	from month 12 to 60

Collaborators and Investigators

• Sponsor: Chiti Arturo
• Investigators: Principal Investigator: Martina Sollini, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Urologic Surgical Procedures; Urogenital Surgical Procedures; Liquid Biopsy; Cystectomy; Conservative Treatment
• Other Study ID Numbers: FUTURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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