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Spots Global Cancer Trial Database for Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

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Trial Identification

Brief Title: Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

Official Title: Magnetic Resonance Imaging Targeted (Fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient A Comparison Study

Study ID: NCT05969704

Study Description

Brief Summary: The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient

Detailed Description: Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men. The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%. while more than 50% of cancers that require definitive treatment remain undetected during initial biopsies . Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during initial prostate biopsies. Multi-parametric prostate MRI has a high sensitivity for the detection of prostate adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on routine systematic trans -rectal ultrasound (TRUS) biopsy . The most recent European Association of Urology guidelines recommend MRI before prostate biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is weak. A systematic 12-core trans-rectal ultrasound-guided systematic biopsy (TRUS-SB) is still carried out for biopsy-naïve men at present. However, the TRUS-SB technique has several limitations, including over-diagnosis of clinically insignificant prostate cancer (CISCa), under-diagnosis of clinically significant prostate cancer (CSCa), false negative biopsy results and biopsy-related complications, such as bleeding and infections . Targeted prostate biopsies from MRI-suspicious lesions have been shown to improve the cancer detection rate (CDR) of CSCa compared with systematic TRUS-guided biopsies . Currently, three biopsy techniques are used for TB from MRI-suspicious lesions: in-bore MRI biopsies, cognitive magnetic resonance imaging trans-rectal ultrasound fusion targeted biopsy (COG-TB) and software guided magnetic resonance imaging-ultrasound fusion targeted biopsies (MRUS-TB). Inbore MRI biopsies that are carried out with an MRI-compatible guidance device can target suspicious lesions accurately; however, such biopsies are time-consuming and expensive . In the COG-TB technique, a physician samples a location that has been visually estimated using ultrasound and is considered to correspond to the location of a suspicious lesion that was detected on MRI. However, when the suspicious lesion is completely invisible (isoechoic or too small) on TRUS, the accuracy of such biopsies is likely reduced . The accuracy of COG-TB might be influenced by multiple factors, including the alignment of prostate landmarks, the physician's experience and so on. for these reasons, MRUS-TB where software fuses the MRI images with real-time TRUS images to guide the operator to biopsy the suspicious lesions is more commonly carried out; however, the optimal TB method remains unclear.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Menoufia University Hospital, Shibin Al Kawm, Menoufia, Egypt

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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