An interventional study of Performing cognitive prostate biopsy with a radiologist's guidance with map and Performing cognitive prostate biopsy without a radiologist's guidance with map in Prostate Cancer, Prostate Adenocarcinoma and Prostatic Neoplasms, sponsored by Marmara University. Completed at 1 site in Turkey. Open to male participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Marmara University · Not applicable, Interventional, and Diagnostic
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
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.
And then the biopsy results will be compared to see the efficacy of mapping
Exclusion Criteria:
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
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
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.
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.
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)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Marmara University