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Clinical Trial Summary

Prostate cancer is the most frequent cancer in men. Today serum prostate specific antigen (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate cancer. In the case of higher PSA levels and/or abnormal DRE, 10-12 core standard transrectal prostate biopsy (STRUS-B) is preferred method.Most of the pathological T1 stage tumours are diagnosed by this method. But as the prostate volume increases, cancer detection rate of STRUS-B decreases.In the last decade multiparametric prostate magnetic resonance imaging (mpMR) has gained importance in the diagnosis of prostate cancer beside the staging. Now it is possible to biopsies from lesions which are suspicious for cancer in mpMR. Recent studies have shown that mpMR guided prostate biopsies either transrectally or perineally have better cancer detection rates comparing STRUS-B, especially in patients with history of negative previous biopsy. But its use in biopsy naive settings is not recommended.In this study it is aimed to compare cancer detection rate of MR guided MR-US fusion transrectal prostate biopsy with STRUS-B.


Clinical Trial Description

A histopathological evaluation of STRUS-B materials based on suspicious DRE findings and high or increasing PSA levels is the gold standard in prostate cancer diagnosis. However, the fact that approximately one-third of malignant prostate lesions is isoechoic and cannot be detected using conventional grayscale transrectal ultrasonography (TRUS) decreases the sensitivity rates of STRUS-B. These restrictions on the use of TRUS have encouraged urologists to use new methods to diagnose prostate cancer. One of these methods is the biopsy of lesions defined using mpMR, which has been widely used for the past 10 years. An MR targeted biopsy can be performed cognitively under MR guidance or using ultrasound devices with fusion software that can combine MR images with sonographic images. mpMR targeted biopsies are recommended in the current clinical practice for re-biopsies of patients who had previous negative biopsy but clinically suspected of cancer, follow-up biopsies of active surveillance, and biopsies of patients who are suspected to have recurrence after local minimally invasive treatment, such as radiotherapy and high-intensity focused ultrasonography. Recent studies showed that the cancer detection rate of mpMRIguided prostate biopsy is between 33.7% and 79.5%, which is higher than that of standard 12-core transrectal biopsy. However, the number of studies evaluating the use of MR targeted prostate biopsy in biopsy naive patients is limited.

In this study it is aimed to compare cancer detection rates of STRUS-B and MR guided MR-US fusion transrectal prostate biopsy in the biopsy naive patient setting.

100 patients will be randomized to STRUS-B arm and another 100 to fusion arm. In the standard arm patients who have high PSA levels and/or suspicious DRE will be undertaken STRUS-B. In the study arm all patients will undergo a multiparametric prostate MR without endorectal coils. MRI will be performed by Siemens Magnetom(Trade mark) 1.5 T (Siemens Medical Solutions, Pennsylvania, USA) MRI system. The images wi,ll be reviewed by an experienced uro-radiologist who has no detailed clinical information about the patients. Suspected areas in T2, T1 contrast, and diffusion-weighted images of multiparametric MRI were reported according to Prostate Imaging Reporting and Data System Version-2 (PIRADS v2). In cases of multiple lesions with different PIRADS scores, the lesion with the highest PIRADS score will be accepted as dominant lesion. Biopsy procedures will be performed under local anesthesia or sedoanalgesia. However, sedoanalgesia will be preferred if the patient could not tolerate pain during the penetration of US probe due to low pain threshold or anal canal stricture due to previous rectal surgeries. The procedure will be performed in outpatient clinic conditions. Transrectal ultrasonography will be performed by using an ultrasonography system with rigid fusion software (LOGIQ E9; General Electric, Massachusetts, USA) when patients lie on the left decubitus position. Rectal lidocaine gel will be applied 5 min before rectal US probe is introduced. A sonographic examination of the prostate tissue will be performed to check the presence of prominent lesions. Total prostate volumes will be measured. Multiparametric prostate MRI images will be uploaded to the US system on the day of biopsy. After segmentation (matching) of MRI images with sonographic images, the lesions reported in mpMR will be marked. The periprostatic block will be then performed with 2% prilocaine hydrochloride (20 mg/mL) injected into the neurovascular bundle on both sides of the prostate, with 5 mL to the right and 5 mL to the left. Following the block, two to five core biopsies from the MRI-targeted lesions with PIRADS ≥3 will be obtained. All procedures in fusion biopsy will be performed by two urologists experienced and trained in transrectal prostate ultrasonography and biopsy. After the F-TRUS biopsy completed, a standard 12-core TRUS biopsy will performed on fusion group. STRUS_B arm only standard 12 core transrectal prostate biopsy will be performed. A histopathological evaluation of biopsy specimens will be performed by a uro-pathologist with >10 years of experience. The percentage of cancer within the core, primary, and secondary Gleason score and grade according to the 2014 International Society of Urological Pathology (ISUP) grade will be specified in the final pathology report. Patients reported with high-grade prostatic intraepithelial neoplasm in three or more cores or atypical small acinar proliferation will be redirected to rebiopsy, but they will be included to the benign group in the evaluation of the present study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03936296
Study type Interventional
Source TC Erciyes University
Contact Abdullah Demirtas, Assoc. Prof
Phone +905325094494
Email mesane@gmail.com
Status Recruiting
Phase N/A
Start date April 6, 2017
Completion date December 31, 2020

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