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Comparing two prostate biopsy methods for finding prostate cancer

Compares biopsy near the MRI-visible spot with whole-prostate sampling in men suspected of prostate cancer.

Key facts

Who runs it
GCS Ramsay Santé pour l'Enseignement et la Recherche
Where
Bordeaux, Marseille, Mont-de-Marsan, Paris, and Quint-Fonsegrives, FranceSee the 5 sites
Trial code
Registry title
Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer
Status
Not yet recruiting
People taking part
456 people, planned
Started
Oct 2026
Expected to end
Oct 2028
Type of study
Interventional
Treatments tested
  • Prostate biopsy
Record updated
15 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men who are suspected of having prostate cancer and need a prostate biopsy. Their MRI scan must show a suspicious area.

Age
18 years or older
Sex
Men only
Disease stage
Suspected prostate cancer. The MRI must show a PI-RADS 4 or 5 lesion, or a PI-RADS 3 lesion with a PSA density of 0.15 ng/ml/cc or more. PSA must be 20 ng/mL or lower.
Earlier treatment
No history of prostate cancer and no earlier negative prostate biopsy.
Biomarker or test result
PSA of 20 ng/mL or lower. PSA density of 0.15 ng/ml/cc or more if the MRI shows PI-RADS 3.

Main reasons for not taking part

  • History of prostate cancer
  • Earlier negative prostate biopsy
  • MRI negative (PI-RADS 1 or 2), or PI-RADS 3 with PSA density below 0.15 ng/ml/cc
  • Cannot understand the study or give informed consent
  • Under full or partial legal guardianship

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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.)
  • 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

Where in France

  • CHU de BordeauxBordeaux, FranceContact: Robert Gregoire, DrNo longer taking part
  • Hôpital Nord, Assistance Publique des Hôpitaux de MarseilleMarseille, FranceContact: Michael Baboudjian, DrNo longer taking part
  • CHI Mont de Marsan - Site de LaynéMont-de-Marsan, FranceContact: Jean-Jacques Patard, DrNo longer taking part
  • Hôpital privé des Peupliers - Ramsay SantéParis, FranceContact: Victor Basset, DrNo longer taking part
  • Clinique La Croix du Sud - Ramsay SanteQuint-Fonsegrives, FranceContact: Guillaume Ploussard, DrNo longer taking part

About the trial

What the trial wants to find out

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".

Read full original descriptionShow less

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.

The group in the trial

  • New prostate biopsy schemeOther group

    Control and experimental performed in the same arm

    Treatment: Prostate biopsy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer
Plain-language title
Comparing two prostate biopsy methods for finding prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
15 September 2026