The Efficacy of Mapping for Cognitive Prostate Biopsy

NCT05902637 | Completed

• 1 other identifier: MAR.UAD.006
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer; Prostate Adenocarcinoma; Prostatic Neoplasms; Prostate Disease; Prostate Cancer Stage

Keywords

Prostate; Cancer; Mapping; Genitourinary Radiology; Transrectal; Biopsy; Rectal examination; Method; Efficacy; Prostate mapping; Cognitive; prospective; Randomized

Outcome Measures

Primary Outcomes (1)

• Detecting prostate cancer

  Detection of any kind or any grade of prostate cancer on the pathological specimen of Transrectal Ultrasound Guided Prostate Biopsy: * Detection of prostate adenocarcinoma of any ISUP (grade 1, grade 2, grade 3, grade 4 or grade 5) / Gleason score (Gleason score 6-10) * Detection of non-adenocarcinoma cancers of prostate (small cell carcinoma, neuroendocrine tumor, sarcomatous carcinoma, signet ring cell, basaloid carcinoma, pseudohyperplastic carcinoma, lymphoepithelioma-like carcinoma, adenosquamous cell carcinoma)

  6 months

Study Arms (2)

Prostate Mapping Used

ACTIVE COMPARATOR

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

Procedure: Performing cognitive prostate biopsy with a radiologist's guidance with map

Prostate Mapping not Used

SHAM COMPARATOR

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

Procedure: Performing cognitive prostate biopsy without a radiologist's guidance with map

Interventions

Performing cognitive prostate biopsy with a radiologist's guidance with map PROCEDURE

All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

Prostate Mapping Used

Performing cognitive prostate biopsy without a radiologist's guidance with map PROCEDURE

All patients will undergo cognitive prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after reported by a single genitourinary radiologist in the Department of Radiology of our hospital.

Prostate Mapping not Used

Eligibility Criteria

• Age: 40 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, School of Medicine, Department of Urology

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (8)

• Culp 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 BACKGROUND

• Bell 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 BACKGROUND

• Jansson 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 BACKGROUND

• Lendinez-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 BACKGROUND

• Oerther 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 BACKGROUND

• Barkovich 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.

  PMID: 30807218 BACKGROUND

• Presti JC Jr. Prostate biopsy: how many cores are enough? Urol Oncol. 2003 Mar-Apr;21(2):135-40. doi: 10.1016/s1078-1439(03)00006-1.

  PMID: 12856642 BACKGROUND

• Wegelin O, Exterkate L, van der Leest M, Kummer JA, Vreuls W, de Bruin PC, Bosch JLHR, Barentsz JO, Somford DM, van Melick HHE. The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies. Eur Urol. 2019 Apr;75(4):582-590. doi: 10.1016/j.eururo.2018.11.040. Epub 2018 Dec 3.

  PMID: 30522912 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Neoplasms

Interventions

Microtubule-Associated Proteins

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microtubule Proteins; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• Haydar Kamil Cam, Prof.

  Marmara University, School of Medicine, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associating Professor, MD

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: June 15, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)