Clinical trial · Interventional
The Efficacy of Mapping for Cognitive Prostate Biopsy
The Efficacy of Mapping for Cognitive Prostate Biopsy: a Prospective, Randomized Study
- 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)
Today, many centers still perform Magnetic Resonance Imaging (MRI) cognitive prostate biopsy. The efficacy of detecting clinically significant prostate cancer, which is thought to be due to the experience of the urologist who performed the sampling and the difference in experience of the radiologists who performed the Multiparametric Prostate Magnetic Resonance (MPMR) evaluation, has been reported between 25% and 34% in the literature. In order to eliminate this reporting and sampling difference, The goal of this interventional study is to compare the effectiveness of Multiparametric Prostate Magnetic Resonance (MPMR) Imaging routinely taken before biopsy with a single-center randomized and prospective study and prostate biopsies to be performed by the same urologist with the mapping technique created by a single genitourinary radiologist working in our center with standard cognitive prostate biopsy and to contribute to the literature Type of study: Clinical trial participant population: Male patients with elevated serum Prostate Specific Antigen (PSA) or indicated prostate biopsy by Magnetic Resonance Imaging (MRI) imaging and underwent Multiparametric Prostate Magnetic Resonance (MPMR) before the procedure Participants will undergo transrectal prostate biopsy with or without mapping, Researches will compare to see if the cancer detection rates differ
Conditions
Conditions (5)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Stage | — | UNRESOLVED | — |
| Prostate Disease | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Performing cognitive prostate biopsy with a radiologist's guidance with map | Procedure | — | UNRESOLVED |
| Performing cognitive prostate biopsy without a radiologist's guidance with map | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prostate Mapping Used
- description
- Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy
- interventionNames
- Procedure: Performing cognitive prostate biopsy with a radiologist's guidance with map
- type
- SHAM_COMPARATOR
- label
- Prostate Mapping not Used
- description
- Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have not been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy. Surgeon assesses the Multiparametric Prostate Magnetic Resonance (MPMR) imaging's by him/herself
- interventionNames
- Procedure: Performing cognitive prostate biopsy without a radiologist's guidance with map
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with elevated serum Prostate Specific Antigen (PSA) * Indicated prostate biopsy by MR imaging and underwent Multiparametric Prostate Magnetic Resonance (MPMR) imaging before the procedure Exclusion Criteria: * Patients with suspicious Rectal Examination findings * Patients who cannot enter Multiparametric Prostate Magnetic Resonance (MPMR) imaging for various reasons (such as Multiparametric Prostate Magnetic Resonance (MPMR) imaging incompatible pacemaker, Chronic Kidney Disease) * Patients with diagnosed prostate cancer and active surveillance * Patients without indication for prostate biopsy * Patients with very high serum Prostate Specific Antigen (PSA) levels (\>15) * Patients who are planned to start treatment by diagnosing with standard 12 core biopsy without losing time with imaging method * Patients who do not want to participate in the study.
References
Publications (8)
- 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
- BACKGROUNDBell KJ, Del Mar C, Wright G, Dickinson J, Glasziou P. Prevalence of incidental prostate cancer: A systematic review of autopsy studies. Int J Cancer. 2015 Oct 1;137(7):1749-57. doi: 10.1002/ijc.29538. Epub 2015 Apr 21. PMID 25821151
- BACKGROUNDJansson KF, Akre O, Garmo H, Bill-Axelson A, Adolfsson J, Stattin P, Bratt O. Concordance of tumor differentiation among brothers with prostate cancer. Eur Urol. 2012 Oct;62(4):656-61. doi: 10.1016/j.eururo.2012.02.032. Epub 2012 Feb 24. PMID 22386193
- BACKGROUNDLendinez-Cano G, Ojeda-Claro AV, Gomez-Gomez E, Morales Jimenez P, Flores Martin J, Dominguez JF, Amores J, Cozar JM, Bachiller J, Juarez A, Linares R, Garcia Galisteo E, Alvarez Ossorio JL, Requena Tapia MJ, Moreno Jimenez J, Medina Lopez RA; AEU-PIEM/2018/000 Investigators. Prospective study of diagnostic accuracy in the detection of high-grade prostate cancer in biopsy-naive patients with clinical suspicion of prostate cancer who underwent the Select MDx test. Prostate. 2021 Sep;81(12):857-865. doi: 10.1002/pros.24182. Epub 2021 Jun 29. PMID 34184761
- BACKGROUNDOerther B, Engel H, Bamberg F, Sigle A, Gratzke C, Benndorf M. Cancer detection rates of the PI-RADSv2.1 assessment categories: systematic review and meta-analysis on lesion level and patient level. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):256-263. doi: 10.1038/s41391-021-00417-1. Epub 2021 Jul 6. PMID 34230616
- BACKGROUNDBarkovich EJ, Shankar PR, Westphalen AC. A Systematic Review of the Existing Prostate Imaging Reporting and Data System Version 2 (PI-RADSv2) Literature and Subset Meta-Analysis of PI-RADSv2 Categories Stratified by Gleason Scores. AJR Am J Roentgenol. 2019 Apr;212(4):847-854. doi: 10.2214/AJR.18.20571. Epub 2019 Feb 26.