Feasibility Study of Urinary cfDNA Analysis as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- concentration of cfDNA obtained in urine [Time frame: 6 months]
Secondary outcome measures (2)
- Distribution of circulating tumour DNA sizes in urine (urinary cfDNA) [Time frame: 6 months]
- mutational load variation [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07468838 · ICO-2025-22 · 2025-A02694-45