TransPERineal Fusion Biopsy Versus transrECTal

NCT05069584 | Completed

• 1 other identifier: 2021-A01793-38
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of the targeted biopsy in terms of detection of significant cancers.

  Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.

  Day 21

Study Arms (2)

transperineal biopsy

EXPERIMENTAL

The strategy evaluated is based on performing targeted and systematized prostate biopsies performed by the transperineal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.

Procedure: Biopsy

transrectal biopsy

ACTIVE COMPARATOR

The comparison strategy is based on performing targeted and systematized prostate biopsies performed by the transrectal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

patient must have a biopsy for his prostate cancer

transperineal biopsy; transrectal biopsy

Eligibility Criteria

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

You may qualify if:

• Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center;
• Patient with at least one PI-RADS 4-5 lesion on MRI;
• Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized;
• Patient with negative pre-biopsy antibacteriological urine examination ;
• Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL;
• Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study.

You may not qualify if:

• Patient who has already had a prostate biopsy;
• Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8
• Patient with negative MRI or whose lesions have a PI-RADS score \<4;
• Patient with impassable rectal stenosis;
• Patient with a dermatological disease preventing perineal access;
• Patient with rectal amputation;
• Patient presenting with a urinary tract infection;
• Patient on anticoagulant treatment at an effective oral dose, not relayed;

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique La Croix Sud

Quint-Fonsegrives, 31130, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: January 17, 2022
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)