NCT05902637Completed
The Efficacy of Mapping for Cognitive Prostate Biopsy
The Efficacy of Mapping for Cognitive Prostate Biopsy: a Prospective, Randomized Study
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 17 Mar 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Marmara University
- Diseases
- Prostate cancer
- NCT number
- NCT05902637
What you commit to
- Study type: Interventional
- Participants enrolled: 175
- From 1 Mar 2023 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Patients with very high serum Prostate Specific Antigen (PSA) levels (\>15)
Other
- Patients with suspicious Rectal Examination findings
- Patients without indication for prostate biopsy
- 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.
Who the study is looking for
- 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
Age in the registry: 40 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marmara University, School of Medicine, Department of Urology Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.