Feasibility Study of Urinary cfDNA Analysis as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer (UroDNA)

March 12, 2026 updated by: Institut Cancerologie de l'Ouest

Feasibility Study of Circulating Tumour DNA Analysis in Urine (Urinary cfDNA) as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer

The UroDNA study is a feasibility study (RIPH category 3) aimed at evaluating the analysis of circulating tumour DNA in urine (urinary cfDNA) as a non-invasive monitoring tool in patients with prostate or bladder cancer. Urine samples will be collected at different times during the course of treatment to define the optimal conditions for cfDNA collection, extraction and analysis, and to explore the detection of tumour mutation profiles. This study does not involve any experimental treatment. Its objective is to validate the technical and clinical feasibility of a molecular monitoring urine test, which could offer a simple and non-invasive alternative to improve the management of urological cancers.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Patients will be included as they are admitted to the facility. If they agree to participate, two urine samples will be collected at the start of treatment and at the end of the treatment sequence.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Laetitia HIMPE
Phone Number: +33 240679747
Email: promotionrc@ico.unicancer.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

patients with prostate or bladder cancer

Description

Inclusion Criteria:

1) Five patients for each of the following cancers :

Patients with high-risk localised prostate cancer eligible for high-dose radiotherapy, or
Patients with mHSPC eligible for docetaxel chemotherapy, or
Patients with mCRPC in second-line treatment eligible for luPSMA treatment, or
Patients with localised bladder cancer eligible for neoadjuvant chemotherapy or,
Patients with metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)

Exclusion Criteria:

History of cancer in the 5 years prior to entering the trial other than basal cell skin cancer or cervical carcinoma in situ,
Women who are pregnant, likely to become pregnant or breastfeeding,
Persons deprived of their liberty, under judicial protection, under guardianship or placed under the authority of a guardian, Inability to undergo medical follow-up for the trial for geographical, social or psychological reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
prostate cancer eligible for high-dose-rate radiotherapy Patients with high-risk localised prostate cancer who are eligible for high-dose-rate radiotherapy
prostate cancer eligible for docetaxel chemotherapy Patients with mHSPC eligible for docetaxel chemotherapy
prostate cancer eligible for treatment with luPSMA Patients with mCRPC in second-line treatment eligible for treatment with luPSMA
Bladder cancer eligible for neoadjuvant chemotherapy Patients with localised bladder cancer eligible for neoadjuvant chemotherapy
metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro) Patients with metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of cfDNA obtained in urine Time Frame: 6 months	concentration of cfDNA obtained in urine	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA) Time Frame: 6 months	Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)	6 months
mutational load variation Time Frame: 6 months	mutational load variation	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Manon MD DE VRIES BRILLAND, ICO Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ICO-2025-22
2025-A02694-45 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Obtaining preliminary data and evaluation of feasibility

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.