Cognitive and Fusion Prostatic Biopsy (CTB-FTB)

Menoufia University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Cognitive-targeted prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07306741

UROL 22

Details and patient eligibility

About

The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). 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.

Full description

This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng/mL).

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.

Enrollment: 80 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

Biopsy-naïve patients

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

Prior prostate biopsy

Prostate-specific Antigen level outside the specified range

Contraindication to Magnetic Resonance Imaging

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy

Experimental group

Description:

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.

Treatment:

Procedure: Cognitive-targeted prostate biopsy