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

NCT07468838 | Not Yet Recruiting

• 2 other identifiers: ICO-2025-222025-A02694-45
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Prostate Cancer; Bladder Cancer

Keywords

urinary cfDNA; prostate cancer; bladder cancer

Outcome Measures

Primary Outcomes (1)

• concentration of cfDNA obtained in urine

  concentration of cfDNA obtained in urine

  6 months

Secondary Outcomes (2)

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

  6 months

• mutational load variation

  6 months

Study Arms (5)

prostate cancer eligible for high-dose-rate radiotherapy

Patients with high-risk localised prostate cancer who are eligible for high-dose-rate radiotherapy

prostate cancer eligible for docetaxel chemotherapy

Patients with mHSPC eligible for docetaxel chemotherapy

prostate cancer eligible for treatment with luPSMA

Patients with mCRPC in second-line treatment eligible for treatment with luPSMA

Bladder cancer eligible for neoadjuvant chemotherapy

Patients with localised bladder cancer eligible for neoadjuvant chemotherapy

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)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men for Prostate Cancer Men or Women for bladder cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with prostate or bladder cancer

You may qualify if:

• \) 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Biospecimen

Retention: SAMPLES WITH DNA

urine samples

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases

Study Officials

• Manon MD DE VRIES BRILLAND

  ICO Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia HIMPE

CONTACT

+33 240679747; promotionrc@ico.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share