Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

Trial Title: Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

NCT ID: NCT05969704

Condition: Prostatic Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
fusion biopsy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Intervention:

Intervention type: Procedure
Intervention name: MRI fusion targeted prostatic biopsy
Description: combines the pictures from an MRI and an ultrasound to create a detailed 3-D image of the prostate. This procedure makes it easier to see an abnormal lesion of prostate in order to guide the biopsy needle into the abnormal lesion
Arm group label: fusion biopsy

Other name: fusion biopsy

Intervention type: Procedure
Intervention name: MRI cognitive targeted prostatic biopsy
Description: the biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and of the lesion within it to take a biopsy from the lesion
Arm group label: cognitive biopsy

Other name: cognitive biposy

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - prostate biopsy-naïve men - PSA levels of up to 20 ng/mL - Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5. Exclusion Criteria: - PSA level greater than 20 ng/mL - patient with history of TRUS biopsy - patient diagnosed as cancer prostate or with distant metastasis

Gender: Male

Gender based: Yes

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Menoufia University Hospital

Address:
City: Shibin Al Kawm
Zip: 13829
Country: Egypt

Status: Recruiting

Contact:
Last name: Ahmed A Gamal Eldin, professor

Phone: 201005207564
Email: agamaleldeen@yahoo.com

Contact backup:
Last name: Mohammed K Omar, assistant professor

Phone: 201066949454
Email: KIMO_81eg@yahoo.com

Start date: January 1, 2023

Completion date: October 1, 2024

Lead sponsor:
Agency: Menoufia University
Agency class: Other

Source: Menoufia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05969704