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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial population

patients with prostate or bladder cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

25 Participants
are grouped into 5 trial groups
Group A: prostate cancer eligible for high-dose-rate radiotherapy
Group B: prostate cancer eligible for docetaxel chemotherapy
Group C: prostate cancer eligible for treatment with luPSMA
Group D: Bladder cancer eligible for neoadjuvant chemotherapy
Group E: metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)

Trial outcomes

Primary outcomes

1

concentration of cfDNA obtained in urine

concentration of cfDNA obtained in urine

Time frame
6 months

Secondary outcomes

1

Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)

Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)

Time frame
6 months
2

mutational load variation

mutational load variation

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: