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

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT07468838
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: prostate cancer eligible for high-dose-rate radiotherapy
    Patients with high-risk localised prostate cancer who are eligible for high-dose-rate radiotherapy
  • Arm: prostate cancer eligible for docetaxel chemotherapy
    Patients with mHSPC eligible for docetaxel chemotherapy
  • Arm: prostate cancer eligible for treatment with luPSMA
    Patients with mCRPC in second-line treatment eligible for treatment with luPSMA
  • Arm: Bladder cancer eligible for neoadjuvant chemotherapy
    Patients with localised bladder cancer eligible for neoadjuvant chemotherapy
  • Arm: 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)

Primary Outcome Measure

concentration of cfDNA obtained in urine [ Time Frame: 6 months ]

Central Contacts

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Bladder cancer trialsProstate cancer trialsOncology trialsUrology trialsProstate oncology trialsMen's health trials

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