Evaluating MRI-targeted prostate biopsies for treatment decisions
Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study
This study tests if using MRI-targeted biopsies helps doctors make better treatment decisions for men aged 50 to 75 who might have prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Antony) |
| Trial ID | NCT05612204 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess how treatment decisions for suspected prostate cancer are influenced by targeted biopsies performed under MRI compared to traditional systematic biopsies. The study will involve male patients aged 50 to 75 who have a suspicious lesion detected via MRI. By comparing the outcomes of treatment decisions made in multidisciplinary meetings based on these biopsy methods, the trial seeks to determine the effectiveness and contribution of MRI-targeted biopsies in clinical practice. The study is particularly relevant given the rising incidence of prostate cancer and the need for improved diagnostic techniques.
Who should consider this trial
Good fit: Ideal candidates are French-speaking men aged 50 to 75 with a PSA greater than 4 and a single lesion with a PI-RADS score of 3 or higher.
Not a fit: Patients with contraindications to MRI, multiple targets, or lower PI-RADS scores will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate treatment decisions for patients with suspected prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using MRI-targeted biopsies for prostate cancer diagnosis, indicating that this approach is gaining traction in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Antony
- Hpa — Antony, France (Recruiting)
Study contacts
- Study coordinator: Stephane Locret
- Email: dre@ramsaygds.fr
- Phone: +33 1 87 86 22 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.