Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study

NCT ID: NCT05612204

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2024-06-30

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.

Detailed Description

Prostate cancer is the most common cancer in France and is the third most common cancer death in men.

Early detection is based on family and ethnic history, digital rectal examination and total PSA testing. It is done at age 50 for the general population but is restricted to men with an estimated survival of more than 10 years.

In case of clinical suspicion of prostate cancer, the diagnosis is based on the realization of prostate biopsies. Until recently, 12 so-called "systematic" (BS) biopsies were performed under ultrasound control, according to a standardized protocol, which allowed sampling of the entire prostate.

Since the latest recommendations of the French Association of Urology in 2020, an MRI is systematically indicated before performing biopsies. Indeed, MRI is a sensitive technique that will increase the suspicion of significant prostate cancer. An MRI is considered "positive" if at least one suspicious area with a PI-RADS score ≥ 3 is detected. In this case, the French Association of Urology recommends performing so-called targeted biopsies (BC) on these suspicious areas associated with the 12 SBs.

From a technical point of view, ultrasound is the reference examination for performing targeted biopsies on suspicious lesions detected on MRI, either by visual guidance (cognitive identification) or by image fusion techniques, MRI and ultrasound.

It is now technically possible to perform biopsies directly under MRI in clinical practice, but the development of this approach remains limited in France. This technique makes it possible to biopsy the suspect area without resorting to image fusion, thus limiting targeting errors.

As only MRI can detect cancerous lesions, this study is based on the hypothesis that targeted biopsies alone taken under MRI could make it possible to make a therapeutic decision within the framework of a multidisciplinary consultation meeting (RCP) without resorting to systematic biopsies under ultrasound.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biopsy under MRI

Group Type: EXPERIMENTAL

Biopsy under MRI

Intervention Type: PROCEDURE

Biopsy under MRI

Interventions

Biopsy under MRI

Biopsy under MRI

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HPA

Antony, , France

Site Status: RECRUITING

Countries

France

Central Contacts

STEPHANE LOCRET

Role: CONTACT

dre@ramsaygds.fr

+33 1 87 86 22 79

Other Identifiers

2022-A00792-41

Identifier Type: -

Identifier Source: org_study_id