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Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

Primary Purpose

Prostatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MRI fusion targeted prostatic biopsy
MRI cognitive targeted prostatic biopsy
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Cancer focused on measuring fusion biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Menoufia University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fusion biopsy

cognitive biopsy

Arm Description

This biopsy procedure that 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 area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment.

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 it

Outcomes

Primary Outcome Measures

detection of clinically significant prostate cancer
accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer

Secondary Outcome Measures

Full Information

First Posted
July 23, 2023
Last Updated
August 21, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05969704
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer
Keywords
fusion biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fusion biopsy
Arm Type
Active Comparator
Arm Description
This biopsy procedure that 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 area of prostate in order to guide the biopsy needle into the abnormal area. A sample of tissue can then be taken and checked under a microscope for cancer. A fusion biopsy may help find prostate cancer cells that may be missed with other types of biopsies. It may help find cancer at an early stage and plan cancer treatment.
Arm Title
cognitive biopsy
Arm Type
Active Comparator
Arm 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 it
Intervention Type
Procedure
Intervention Name(s)
MRI fusion targeted prostatic biopsy
Other Intervention Name(s)
fusion biopsy
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
MRI cognitive targeted prostatic biopsy
Other Intervention Name(s)
cognitive biposy
Intervention 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
Primary Outcome Measure Information:
Title
detection of clinically significant prostate cancer
Description
accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer
Time Frame
two weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mehanna
Phone
201026906035
Email
ahmedmehana1994@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed I Abuzaid
Phone
201068588750
Email
Mabuzaid84@yahoo.com
Facility Information:
Facility Name
Menoufia University Hospital
City
Shibin Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Gamal Eldin, professor
Phone
201005207564
Email
agamaleldeen@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammed K Omar, assistant professor
Phone
201066949454
Email
KIMO_81eg@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fusion Versus Cognitive MRI Targeted Prostatic Biopsy

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