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

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.

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.

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.