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NOT YET RECRUITING
NCT07296042
NA

Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer

Sponsor: Ramsay Générale de Santé

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

456

Start Date

2026-03

Completion Date

2028-03

Last Updated

2025-12-22

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Prostate biopsy

The intervention for this study will be a modification of the standard prostate biopsy scheme. Instead of a targeted + systematic biopsy (3 targeted and 12 systematic biopsies (6 in each lobe)), the following 15 biopsies will be performed: * 3 targeted biopsies * 4 regional biopsies * 8 systematic biopsies (2 posterior right, 2 lateral right, 2 posterior left, 2 lateral left)

Locations (5)

CHU de Bordeaux

Bordeaux, France

Hôpital Nord, Assistance Publique des Hôpitaux de Marseille

Marseille, France

CHI Mont de Marsan - Site de Layné

Mont-de-Marsan, France

Hôpital privé des Peupliers - Ramsay Santé

Paris, France

Clinique La Croix du Sud - RAMSAY Santé

Quint-Fonsegrives, France