Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-12-20
2026-08-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure.
The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.
Participants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.
The study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology \[ISUP\] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.
No results are reported in this section. Study outcomes will be entered in the Results Section after study completion.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequential Cognitive-Targeted Biopsy Followed by Fusion-Targeted Biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session. Each participant will receive both biopsy techniques sequentially, allowing within-subject comparison. Participants will be assigned to one of two surgeons using a blinded randomization process; however, all participants will receive the same intervention protocol.
Cognitive-Targeted Prostate Biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive-Targeted Prostate Biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Prostate-specific antigen level between 4 and 20 ng/mL
Multiparametric magnetic resonance imaging Prostate Imaging-Reporting and Data System score 4 or 5
Exclusion Criteria
Prostate-specific antigen level outside the specified range
Contraindication to magnetic resonance imaging
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Menoufia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mahmoud Ahmed Mohammed
ASSISTANT LECTURER
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Menoufia university hospital urology department
Shibīn al Kawm, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mahmoud A Wahbah, MASTER
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UROL 22
Identifier Type: -
Identifier Source: org_study_id