Prostate CancerUroDNANCT07468838
Feasibility Study of Urinary cfDNA Analysis as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer
An observational study of Prostate Cancer and Bladder Cancer, run by Institut Cancerologie de l'Ouest.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Bladder Cancer
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: patients with prostate or bladder cancer
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Bladder Cancer
- Keywords
- urinary cfDNA, prostate cancer, bladder cancer
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
concentration of cfDNA obtained in urine
concentration of cfDNA obtained in urine
Measured: 6 months
Secondary outcomes (2)
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
Measured: 6 months
mutational load variation
mutational load variation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon MD DE VRIES BRILLAND, Principal investigator, ICO Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468838
- Sponsor's protocol ID
- ICO-2025-22
- Other IDs
- 2025-A02694-45
- Acronym
- UroDNA
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Obtaining preliminary data and evaluation of feasibility
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Circulating Tumour DNA Analysis in Urine (Urinary cfDNA) as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer
- ClinicalTrials.gov ID
- NCT07468838
- Acronym / sponsor ID
- UroDNA / ICO-2025-22
- Conditions
- Prostate Cancer, Bladder Cancer
- Keywords
- urinary cfDNA, prostate cancer, bladder cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Mar 2026 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with prostate or bladder cancer
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of cfDNA obtained in urine
Time frame: 6 months
concentration of cfDNA obtained in urine
2 secondary outcomes
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
Time frame: 6 months
mutational load variation
Time frame: 6 months
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 16 Mar 2026.
- Individual participant dataSharing planned: No. Obtaining preliminary data and evaluation of feasibility
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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.
Manon MD DE VRIES BRILLAND principal investigator
ICO Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Bladder Cancer, run by Institut Cancerologie de l'Ouest.
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 6 inclusion and 3 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Laetitia HIMPE (+33 240679747, promotionrc@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of cfDNA obtained in urine (time frame: 6 months). 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 16 Mar 2026.