Targeted And Perilesional Or Systematic Biopsy In Prostate Cancer

NCT07296042 | Not Yet Recruiting

• 2 other identifiers: COS-RGDS-2025-06-003-TARGET2025-A02500-49
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 5

Brief 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

Prostate Cancer

Keywords

MRI; biopsy; prostate cancer detection; clinically significant prostate cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the targeted + regional biopsy scheme for the detection of clinically significant prostate cancer

  The primary endpoint is the sensitivity and specificity of the targeted + regional biopsy scheme for the detection of clinically significant PCa (ISUP grade group ≥ 2) compared to the sensitivity and specificity of the targeted + systematic biopsy scheme (standard of care). A biopsy will be considered negative if there is no cancer or only insignificant PCa (ISUP grade 1 group) detected. A biopsy will be considered positive if there is clinically significant PCa (ISUP grade ≥ 2 group) detected.

  On the day of the biopsy (up to day 90)

Secondary Outcomes (3)

• Detection of not significant prostate cancer

  On the day of the biopsy (up to day 90)

• Detection of agressive prostate cancer

  On the day of the biopsy (up to day 90)

• Creation of a nomogram for the detection of clinically significant prostate cancer

  On the day of the biopsy (up to day 90)

Study Arms (1)

New prostate biopsy scheme

OTHER

Control and experimental performed in the same arm

Procedure: Prostate biopsy

Interventions

Prostate biopsy PROCEDURE

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)

New prostate biopsy scheme

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of prostate cancer
• History of negative prostate biopsy
• MRI negative (PI-RADS 1 or 2) or equivocal (PI-RADS 3) with PSA density \< 0.15 ng/ml/cc
• Patient unable to understand the terms of the study or unable to give informed consent (neurological or psychiatric disorders, non-French speaker, etc.)
• Patient under full or partial legal guardianship.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Nord, Assistance Publique des Hôpitaux de Marseille

Marseille, 13015, France

Location

CHI Mont de Marsan - Site de Layné

Mont-de-Marsan, 40024, France

Location

Hôpital privé des Peupliers - Ramsay Santé

Paris, 75013, France

Location

Clinique La Croix du Sud - RAMSAY Santé

Quint-Fonsegrives, 31130, France

Location

Related Publications (1)

• Baboudjian M, Sordelli F, Patard JJ, Moussi B, Graffeille V, Basset V, Legraverend D, Bastide C, Daniel L, Beauval JB, Roupret M, Robert G, Ploussard G. Targeted and Perilesional or Systematic Biopsies in Prostate Cancer: The TARGET Clinical Trial Protocol. Eur Urol Oncol. 2026 Mar 10:S2588-9311(26)00040-4. doi: 10.1016/j.euo.2026.02.003. Online ahead of print.

  PMID: 41813528 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be its own control as each patient will receive targeted, regional and systematic biopsies of the prostate.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (5)