Cognitive and Fusion Prostatic Biopsy
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorMenoufia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Cognitive-targeted prostate biopsy
Procedure/SurgeryParticipants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Sequential cognitive-targeted biopsy followed by fusion-targeted biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prostate Cancer Detection Rate Assessed by Histopathological Examination
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.
Time frame
During the biopsy session2
Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group
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.
Time frame
During the biopsy sessionSecondary outcomes
1
Biopsy Procedure Time Measured in Minutes
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.
Time frame
During the procedure2
Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging
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.
Time frame
Before the biopsy procedure3
Procedural Metrics According to Surgeon Assignment
Assessment of procedural parameters, including procedure duration, according to surgeon assignment. These outcomes are not reported as scale-based scores.
Time frame
During the biopsy procedureSponsors and contacts
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Source ClinicalTrials.gov