Prostate Cancer
Conditions
Keywords
Cognitive-Targeted Biopsy, Magnetic Resonance Imaging-Ultrasound Fusion Biopsy, Multiparametric Magnetic Resonance Imaging, Transrectal Prostate Biopsy, Prostate Cancer Detection, Diagnostic Accuracy
Brief summary
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.
Detailed 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.
Interventions
PROCEDURECognitive-targeted prostate biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Sponsors
Menoufia University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Detection Rate Assessed by Histopathological Examination | During the biopsy session | Detection of prostate cancer based on histopathological examination of biopsy core specimens obtained using cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is reported as the presence or absence of prostate cancer and is not reported as a numerical score on a scale. |
| Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group | During the biopsy session | Detection of clinically significant prostate cancer based on histopathological evaluation of biopsy specimens obtained using each biopsy technique. Clinically significant prostate cancer is defined using the International Society of Urological Pathology (ISUP) Grade Group classification, which ranges from Grade Group 1 (least aggressive) to Grade Group 5 (most aggressive). Clinically significant disease is defined as ISUP Grade Group 2 or higher. Higher ISUP grade groups indicate a worse pathological outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy Procedure Time Measured in Minutes | During the procedure | Duration of each biopsy technique, measured in minutes from insertion of the ultrasound probe to completion of tissue sampling for cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is a direct time measurement and not a scale-based score. |
| Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging | Before the biopsy procedure | Maximum lesion length measured in millimeters on pre-biopsy multiparametric magnetic resonance imaging. This outcome is a direct physical measurement and not a score on a scale. |
| Procedural Metrics According to Surgeon Assignment | During the biopsy procedure | Assessment of procedural parameters, including procedure duration, according to surgeon assignment. These outcomes are not reported as scale-based scores. |
Countries
Egypt
Contacts
Primary ContactMahmoud A Wahbah, MASTER
Outcome results
None listed