Clinical trial · Interventional
US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer
Prospective Randomized Controlled Study: Free-Hand Transperineal vs. Transrectal Systematic and Image Fusion Targeted Biopsies Under Local Anesthesia Comparing Rate of Significant Cancer Detection and Complication Rates
NCT04797078CI-TRIAL-00064595FLAPPwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planning halted due to changes in the research group constellation.
Summary
Brief summary (as posted)
We are conducting a randomised trial comparing outcomes of transperineal prostate biopsies under free-hand software assisted MRI/US fusion with transrectal biopsy guide software assisted MRI/US fusion. Primary outcome is the detection of clinically significant prostate cancer. Secondary outcomes is rate of complications including infection and sepsis, as well as feasibility and patient tolerability.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transperineal biopsy | Procedure | — | UNRESOLVED |
| Transrectal biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transrectal fusion biopsies of the prostate
- description
- 1. Transrectal approach, patient in left lateral position, local anestesia 10ml lidocaine 1% at prostate base laterally and apex if indicated. 2. MRI-ultrasound fusion-guided biopsies with 4 biopsy cores per lesion, where clinically indicated. 18G biopsy needle. 3. Standard 12-core template for systematic biopsies. 18G biopsy needle. 4. Antibiotic prophylaxis with 750mg ciprofloxaicin, single dose p.o.
- interventionNames
- Procedure: Transrectal biopsy
- type
- EXPERIMENTAL
- label
- Transperineal free hand fusion biopsies of the prostate
- description
- Men randomized to the experimental arm undergoes free-hand targeted transperineal fusion biopsies as defined below. 1. Patient is placed supine in the lithotomy-position. The perineal area is prepared with chlorhexidine 0,5ml/ml. 2. Ropivacain 7,5mg/ml is used as an anesthetic agent. Up to 40ml's (equivalent to 300mg) can be used to anestitize the skin, caudal and cranial part of the urogenital diaphragm and periprostatic tissue. 3. Free-hand MRI-ultrasound fusion-guided biopsies with at least 4 biopsy cores per lesion. Coaxial technique with 18G biopsy needle. 4. 10-12 Systematic biopsies according to the modified Barzell 12-core template. 5. No antibiotic profylaxis unless warranted by immunosuppression, previous sepsis or urinary tract infection.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent to participate * Be aged 18 years and over * An understanding of the Swedish language sufficient to understand written and verbal information about the trial and consent process * Be suited and fit for either procedure (transrectal/transperineal) * Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic purpose (following indications for biopsy) * Biopsy naïve * Men on active surveillance (AS) * Rebiopsy * Be willing and able to comply with scheduled visits and completion of study questionnaires Exclusion Criteria: * Severe illness such as metastatic cancers, sever cardio-vascular disease or dementia * Men with contraindication for a prostate biopsy * Men without suspect lesions on MRI * Previous TURP or other BPH treatment (HoLEP, PostaLUND, water-vaporization) is permitted, but men who have had HIFU, cryo, IRE (irreversible electroporation), photodynamic, or microwave therapy to the prostate will not be included. * Previous treatment with BCG for bladder cancer * Men who are unable to undergo transrectal ultrasonography * Men who have had previous radiation therapy to the pelvis * Men not tolerating ciprofloxacin * Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
References
Publications (13)
- BACKGROUNDCulp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020 Jan;77(1):38-52. doi: 10.1016/j.eururo.2019.08.005. Epub 2019 Sep 5. PMID 31493960
- BACKGROUNDChiu PK, Alberts AR, Venderbos LDF, Bangma CH, Roobol MJ. Additional benefit of using a risk-based selection for prostate biopsy: an analysis of biopsy complications in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. BJU Int. 2017 Sep;120(3):394-400. doi: 10.1111/bju.13913. Epub 2017 Jun 5. PMID 28498624
- BACKGROUNDTurkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18. PMID 30898406
- BACKGROUNDAlberts AR, Roobol MJ, Verbeek JFM, Schoots IG, Chiu PK, Osses DF, Tijsterman JD, Beerlage HP, Mannaerts CK, Schimmoller L, Albers P, Arsov C. Prediction of High-grade Prostate Cancer Following Multiparametric Magnetic Resonance Imaging: Improving the Rotterdam European Randomized Study of Screening for Prostate Cancer Risk Calculators. Eur Urol. 2019 Feb;75(2):310-318. doi: 10.1016/j.eururo.2018.07.031. Epub 2018 Aug 3. PMID 30082150
- BACKGROUNDDrost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019 Apr 25;4(4):CD012663. doi: 10.1002/14651858.CD012663.pub2. PMID 31022301
- BACKGROUNDAhmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.