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NCT Number: NCT05902637

The Efficacy of Mapping for Cognitive Prostate Biopsy

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostate Cancer Stage Prostate Disease Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University, School of Medicine, Department of Urology

Istanbul, 34890, Turkey (Türkiye)

About this study

In this preliminary clinical study, 200 patients who underwent cognitive prostate biopsy under the guidance of transrectal ultrasonography between 01.03.2023 and 01.09.2023 by Marmara University Department of Urology, Department of Urooncology due to serum Prostate Specific Antigen (PSA) elevation and/or abnormal rectal examination findings will be included in the study. All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping or report is extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

In the power analysis, 200 patients were included in the study with the prediction that the efficacy difference would be calculated as 5%. All patients will be randomized to two equal groups by the flip-flip method.

  • Multiparametric Prostate Magnetic Resonance Imaging and reports of the mapped patients will be examined and cognitive prostate biopsy will be performed by looking at the map (Sample Figure 1,2) created by the same urologist and the same radiologist (Sample Figure 1,2). Standard 12 core (6 peripheral zones from both lobes) will be sampled and 4 extra biopsies will be taken from Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas in the mapping.
  • Based on the Multiparametric Prostate Magnetic Resonance Imaging reports and images, without mapping by the radiologist, only the standard 12 core (6 from each peripheral zone from both lobes) determined cognitively by the urologist and 4 extra biopsies from the Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas described in the report will be taken.

And then the biopsy results will be compared to see the efficacy of mapping

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Detecting prostate cancer

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Efficacy of Mapping for Cognitive Prostate Biopsy: a Prospective, Randomized Study

Acronym: MAPROSTATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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