Clinical trial · Interventional
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
NCT03859804CI-TRIAL-00037382completedN/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)
The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Pain Due to Certain Specified Procedures | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI- US fusion prostate biopsy (FPB) | Procedure | — | UNRESOLVED |
| Standard transrectal 12 core biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI
- interventionNames
- Procedure: MRI- US fusion prostate biopsy (FPB)
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- In Group 2, patients who had no suspected lesions or had a PI-RADS \<3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).
- interventionNames
- Procedure: Standard transrectal 12 core biopsy
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA \>2ng/ml for whom aged between 50-60, and PSA \>4ng/ml for whom were above 60 years old * Having suspicious digital rectal examination * having multi-parametric prostate MRI before prostate biopsy * Having MRI defined lesions which were PIRADS - 3 -4-5 Exclusion Criteria: * PSA \> 50 ng/ml * previous negative biopsy * neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure, * patients underwent biopsy under general anesthesia, * having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold
References
Publications (23)
- BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- BACKGROUNDSiddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942. PMID 25626035
- BACKGROUNDGayet M, van der Aa A, Beerlage HP, Schrier BP, Mulders PF, Wijkstra H. The value of magnetic resonance imaging and ultrasonography (MRI/US)-fusion biopsy platforms in prostate cancer detection: a systematic review. BJU Int. 2016 Mar;117(3):392-400. doi: 10.1111/bju.13247. Epub 2015 Aug 28. PMID 26237632
- BACKGROUNDHwang SI, Lee HJ, Lee SE, Hong SK, Byun SS, Lee SC, Choe G. Value of MR-US fusion in guidance of repeated prostate biopsy in men with PSA < 10 ng/mL. Clin Imaging. 2019 Jan-Feb;53:1-5. doi: 10.1016/j.clinimag.2018.09.012. Epub 2018 Sep 22. PMID 30265884
- BACKGROUNDMannaerts CK, Kajtazovic A, Lodeizen OAP, Gayet M, Engelbrecht MRW, Jager GJ, Wijkstra H, de Reijke TM, Beerlage HP. The added value of systematic biopsy in men with suspicion of prostate cancer undergoing multiparametric MRI-targeted biopsy. Urol Oncol. 2019 May;37(5):298.e1-298.e9. doi: 10.1016/j.urolonc.2019.01.005. Epub 2019 Jan 17. PMID 30660493
- BACKGROUNDLuan Y, Huang TB, Gu X, Zhou GC, Lu SM, Tao HZ, Liu BD, Ding XF. Effect of prostate volume on the peripheral nerve block anesthesia in the prostate biopsy: A strobe-compliant study. Medicine (Baltimore). 2016 Jul;95(28):e4184. doi: 10.1097/MD.0000000000004184. PMID 27428215