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Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer

NCT07296042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-12-22

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296042 on ClinicalTrials.gov