Clinical Trial

Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer

Study acronym: TARGET
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07296042
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions Prostate Cancer
Enrollment 456 participants
Start Date 2026-03
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-22