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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07468838

Acronym

UroDNA

Enrollment

Registered

2026-03-13

Start date

2026-05-01

Completion date

2027-12-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Prostate Cancer

Keywords

urinary cfDNA, prostate cancer, bladder cancer

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

1. History of cancer in the 5 years prior to entering the trial other than basal cell skin cancer or cervical carcinoma in situ, 2. Women who are pregnant, likely to become pregnant or breastfeeding, 3. 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.

Design outcomes

Primary

Measure	Time frame	Description
concentration of cfDNA obtained in urine	6 months	concentration of cfDNA obtained in urine

Secondary

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

Contacts

CONTACTLaetitia HIMPE

promotionrc@ico.unicancer.fr+33 240679747

PRINCIPAL_INVESTIGATORManon MD DE VRIES BRILLAND

ICO Angers

Outcome results