Clinical trial · Interventional
TransPERineal Fusion Biopsy Versus transrECTal
Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study
NCT05069584CI-TRIAL-00066607PERFECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- transperineal biopsy
- description
- 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.
- interventionNames
- Procedure: Biopsy
- type
- ACTIVE_COMPARATOR
- label
- transrectal biopsy
- description
- 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.
- interventionNames
- Procedure: Biopsy
Primary outcomes (1)
- measure
- Efficacy of the targeted biopsy in terms of detection of significant cancers.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCalpin GG, Hehir CM, Alzayer M, MacCurtain BM, Ryan FR, Inder MS, Moran DC, Galvin DJ, Breen KJ. Transrectal vs transperineal prostate biopsy: a systematic review and meta-analysis. BJU Int. 2026 Jun;137(6):958-967. doi: 10.1111/bju.70204. Epub 2026 Mar 9. PMID 41800666