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The Efficacy Of Mapping For Cognitive Prostate Biopsy (MAPROSTATE)

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Performing cognitive prostate biopsy with a radiologist's guidance with map
Performing cognitive prostate biopsy without a radiologist's guidance with map
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate, Cancer, Mapping, Genitourinary Radiology, Transrectal, Biopsy, Rectal examination, Method, Efficacy, Prostate mapping, Cognitive, prospective, Randomized

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara University, School of Medicine, Department of UrologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Prostate Mapping Used

Prostate Mapping not Used

Arm 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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 17, 2023
Last Updated
June 5, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05902637
Brief Title
The Efficacy Of Mapping For Cognitive Prostate Biopsy
Acronym
MAPROSTATE
Official Title
The Efficacy Of Mapping For Cognitive Prostate Biopsy: A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate Mapping Used
Arm Type
Active Comparator
Arm 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
Arm Title
Prostate Mapping not Used
Arm Type
Sham Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Performing cognitive prostate biopsy with a radiologist's guidance with map
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Performing cognitive prostate biopsy without a radiologist's guidance with map
Intervention Description
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 Outcome Measure Information:
Title
Detecting prostate cancer
Description
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)
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunus Emre Genc, MD.
Phone
+905070554431
Email
yunusemregencc5@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haydar Kamil Cam, Prof.
Organizational Affiliation
Marmara University, School of Medicine, Department of Urology
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University, School of Medicine, Department of Urology
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haydar Kamil Cam, Professor
Phone
+905323259547
Email
kamilcam@hotmail.com
First Name & Middle Initial & Last Name & Degree
Murat Kars, M.D.
Phone
+905052211138
Email
karsmurat@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31493960
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
22386193
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
34230616
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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The Efficacy Of Mapping For Cognitive Prostate Biopsy

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