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

Prostate Cancer Clinical Trial

— BIOPROSTATIRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612204
• Other study ID #: 2022-A00792-41
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: STEPHANE LOCRET
• Phone: +33 1 87 86 22 79
• Email: dre[@]ramsaygds.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Biopsy under MRI
Biopsy under MRI

Locations

Country	Name	City	State
France	HPA	Antony

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of care offered in multidisciplinary consultation meeting		2 MONTHS