Feasibility Study of Urinary cfDNA Analysis 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.

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Key information

Conditions

Prostate Cancer Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

Primary outcomes

concentration of cfDNA obtained in urine

Time frame: 6 months

concentration of cfDNA obtained in urine

Secondary outcomes

Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)

Time frame: 6 months

Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
mutational load variation

Time frame: 6 months

mutational load variation

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia HIMPE

CONTACT

[email protected]

+33 240679747

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study 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

Acronym: UroDNA

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 13, 2026
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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