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

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well targeted prostate biopsies, which are special tests to check for cancer, help doctors decide on the best treatment for men who might have prostate cancer. The study aims to see if using these targeted biopsies alone or combining them with regular biopsies makes a difference in the treatment decisions made by a team of doctors.

To participate, men aged 50 to 75 who have never had a prostate biopsy before and have signs of potential prostate cancer, such as a high PSA level or an abnormal digital rectal exam, may be eligible. They should also have had a recent MRI that shows a single suspicious area. Participants can expect to have their biopsies done during the study and will be closely monitored by healthcare professionals. It’s important to note that some individuals, like those with certain health conditions or who cannot consent, will not be able to join the study.

Gender

MALE

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