Fusion Versus Cognitive MRI Targeted Prostatic Biopsy
Magnetic Resonance Imaging Targeted (fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient a Comparison Study
1 other identifier
interventional
130
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 23, 2025
January 1, 2025
2 years
July 23, 2023
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
two weeks
Study Arms (2)
fusion biopsy
ACTIVE COMPARATORThis 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.
cognitive biopsy
ACTIVE COMPARATORthe 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- prostate biopsy-naïve men
- PSA levels of up to 20 ng/mL
- Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5.
You may not qualify if:
- PSA level greater than 20 ng/mL
- patient with history of TRUS biopsy
- patient diagnosed as cancer prostate or with distant metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menoufia University Hospital
Shibīn al Kawm, Menoufia, 13829, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 23, 2023
First Posted
August 1, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 23, 2025
Record last verified: 2025-01