NCT05612204

Brief Summary

The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

November 3, 2022

Last Update Submit

February 13, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Type of care offered in multidisciplinary consultation meeting

    2 MONTHS

Study Arms (1)

Biopsy under MRI

EXPERIMENTAL
Procedure: Biopsy under MRI

Interventions

Biopsy under MRIPROCEDURE

Biopsy under MRI

Biopsy under MRI

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient, male, aged between ≥ 50 and ≤ 75 years old
  • Patient with no history of prostate biopsy
  • Patient with a PSA greater than 4 and/or a pathological digital rectal examination
  • Patient having an MRI of interpretable quality carried out within the HPA
  • Patient with a single lesion with a PI-RADS score ≥ 3
  • Affiliated patient or beneficiary of a social security scheme
  • French-speaking patient who signed an informed consent

You may not qualify if:

  • Patient with a contraindication to MRI
  • Patient with multiple targets
  • Patient with lesions with PI-RADS score 1 and 2
  • Patient on long-term anticoagulants and unable to stop it
  • Patient already included in another study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Patient hospitalized without consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HPA

Antony, 92160, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

STEPHANE LOCRET

CONTACT

+33 1 87 86 22 79dre@ramsaygds.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

November 21, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)