Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- prostate cancer eligible for high-dose-rate radiotherapy
- description
- Patients with high-risk localised prostate cancer who are eligible for high-dose-rate radiotherapy
- label
- prostate cancer eligible for docetaxel chemotherapy
- description
- Patients with mHSPC eligible for docetaxel chemotherapy
- label
- prostate cancer eligible for treatment with luPSMA
- description
- Patients with mCRPC in second-line treatment eligible for treatment with luPSMA
- label
- Bladder cancer eligible for neoadjuvant chemotherapy
- description
- Patients with localised bladder cancer eligible for neoadjuvant chemotherapy
- label
- metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available