TransPERineal Fusion Biopsy Versus transrECTal

Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05069584

Acronym

PERFECT

Enrollment

270

Registered

2021-10-06

Start date

2022-01-17

Completion date

2023-05-12

Last updated

2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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

Detailed description

Interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

Interventions

PROCEDUREBiopsy

patient must have a biopsy for his prostate cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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; * Patient participating in another clinical trial, or in a period of exclusion from another clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of the targeted biopsy in terms of detection of significant cancers.	Day 21	Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026