NCT04702633

Brief Summary

The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

January 7, 2021

Last Update Submit

November 17, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerLiquid biopsyBiological samplesNon-invasive diagnosis

Outcome Measures

Primary Outcomes (1)

  • Presence and number of prostate tumour cells in biological samples

    Cell enrichment will be carried out using the ISET® (Isolation by SizE of Tumor/Trophoblastic cells) technology. Identification will be performed by different spectroscopic and/or immune-molecular and/or cytological approaches

    One month after biopsy or until the histological diagnosis will be obtained

Study Arms (2)

Confirmed diagnosis group

Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy.

Other: Results obtained by biopsy and MRI results.Other: Clinical data

Pre-diagnosis group

Patients undergoing prostate biopsy in the context of prostate cancer diagnosis: PSA increases, and / or abnormal digital rectal examination (DRE) and / or an MRI detected signal.

Other: Results obtained by biopsy and MRI results.Other: Clinical data

Interventions

Results obtained by biopsy and MRI results.OTHER

Results obtained by biopsy and MRI results.

Confirmed diagnosis groupPre-diagnosis group
Clinical dataOTHER

Clinical data

Confirmed diagnosis groupPre-diagnosis group

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting the urology department of Cochin Hospital with an indication for prostate biopsy or as part of the monitoring of prostate cancer may be included.

You may qualify if:

  • Patients with a diagnosis of localized or metastatic prostate cancer.
  • No prior or other oncological treatment.
  • Patients undergoing prostate biopsy in the context of prostate cancer diagnosis.
  • Patients with an elevation of PSA (Prostate Specific Antigen), an abnormality on the rectal examination and / or an MRI signal motivating a prostate biopsy,
  • Patients informed and not opposed to participating in the research

You may not qualify if:

  • Patients not affiliated with French social security.
  • Patients unable to understand the protocol.
  • Patients diagnosed with another type of cancer within the past 5 years.
  • Patients prostatectomized and/or treated for prostate cancer.
  • Patients who wear a bladder catheter
  • Patients under guardianship or curatorship
  • Patients under AME

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples (blood, plasma, urines) and paraffin-embedded tissue cuts.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Patrizia PATERLINI-BRECHOT, MD, PhD

    INSERM and Rarecells Diagnostics

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

March 19, 2021

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)