Clinical trial NCT05902637: The Efficacy of Mapping for Cognitive Prostate Biopsy
Official title: The Efficacy of Mapping for Cognitive Prostate Biopsy: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 175
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

1. 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.
2. 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

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.

Primary outcomes:
measure: Detecting prostate cancer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, School of Medicine, Department of Urology
Study officials:
affiliation: Marmara University, School of Medicine, Department of Urology
name: Haydar Kamil Cam, Prof.
role: STUDY_CHAIR
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