NCT07296042Not yet recruiting
Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
Magnetic Resonance Imaging (MRI) improves the detection of clinically significant prostate cancer (PCa) by guiding biopsies of MRI-visible lesions (targeted biopsies) in patients suspected with having PCa. This strategy increases the detection of clinically significant PCa, however, while also increasing the detection of insignificant prostate cancer, often synonymous of "overdiagnosis". It is well known that insignificant PCa has a very low risk of local and distant progression, and active surveillance with a deferred curative treatment protocol based on clear indicators of disease progression is now recommended for all insignificant PCa. However, higher detection of insignificant PCa can lead to patient anxiety about inclusion in an active surveillance protocol, potential further damage from repeated surveillance biopsies and higher healthcare costs. Thus, there is a need for a new biopsy scheme that maintains clinically significant PCa's detection while reducing the diagnosis of insignificant PCa. In recent years, an alternative approach has been to add additional cores close to the target lesion, this is defined as regional biopsies. The hypothesis is that most clinically significant PCa missed in the target are found close to the target. Whereas most cancers found on systematic biopsies outside the MRI target probably correspond to insignificant PCa. This strategy aims to maintain the detection of clinically significant PCa, while reducing the detection of insignificant PCa. This proposed multicenter diagnostic study aims to demonstrate the effectiveness of the experimental biopsy scheme (targeted + regional) in detecting clinically significant PCa, compared with a conventional scheme (targeted + systematic). We also aim to compare the detection of insignificant PCa by both schemes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Diseases
- Prostate cancer
- NCT number
- NCT07296042
What you commit to
- Study type: Interventional
- Planned participants: 456
- From Oct 2026 to the primary completion date, Oct 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of prostate cancer
- History of negative prostate biopsy
- Patient unable to understand the terms of the study or unable to give informed consent (neurological or psychiatric disorders, non-French speaker, etc.)
Other
- MRI negative (PI-RADS 1 or 2) or equivocal (PI-RADS 3) with PSA density \< 0.15 ng/ml/cc
- Patient under full or partial legal guardianship.
Who the study is looking for
- Adult men (≥ 18 years old)
- Clinical suspicion of PCa (based on digital rectal examination, family history, PSA and PSA density values) and prescribed prostate biopsy
- Detection by multi-parametric MRI of the prostate of a PI-RADS 4 or 5 index lesion, or a PI-RADS 3 index lesion with a PSA density ≥ 0.15 ng/ml/cc
- Patient eligible for prostate biopsy under local or general anesthesia
- PSA ≤ 20 ng/mL
- Patient who agreed to participate in the study and signed the consent form
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Nord, Assistance Publique des Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHI Mont de Marsan - Site de Layné Coordinator of this site? Confirm its status | Mont-de-Marsan | France | Unknown status |
| Hôpital privé des Peupliers - Ramsay Santé Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Clinique La Croix du Sud - Ramsay Sante Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Unknown status |
Related publications
- Targeted and Perilesional or Systematic Biopsies in Prostate Cancer: The TARGET Clinical Trial Protocol.Eur Urol Oncol · 2026 · PMID 41813528
This page is information, not medical advice. Discuss any trial with your doctor.