Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-75
SponsorAnkara Etlik City Hospital
About this trial
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).
Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.
The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.
A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 50-75 years.
Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).
Patients with an indication for prostate biopsy.
Patients who are willing to participate and provide informed consent.
Disqualifiers
Previous diagnosis of prostate cancer.
Active urinary tract infection.
Coagulopathy or bleeding disorders preventing prostate biopsy.
Absence of multiparametric prostate MRI evaluation.
Trial design
Design model
Parallel
Treatments tested in this trial
Transrectal Cognitive Fusion Prostate Biopsy
Procedure/SurgeryCognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
Transperineal Cognitive Fusion Prostate Biopsy
Procedure/SurgeryCognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Transrectal Cognitive Fusion Prostate BiopsyActive comparator 1 intervention
Group B: Transperineal Cognitive Fusion Prostate BiopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinically significant prostate cancer detection rate
Comparison of clinically significant prostate cancer (csPCa) detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques. Clinically significant prostate cancer is defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer.
Time frame
Within 4 weeks after biopsy (after final pathological evaluation)Secondary outcomes
1
Overall prostate cancer detection rate
Comparison of overall prostate cancer detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques
Time frame
Within 4 weeks after biopsy (after final pathological evaluation)2
Post-biopsy infectious complications
Assessment and comparison of infectious complications including fever, urinary infection, prostatitis, and sepsis after prostate biopsy.
Time frame
Within 30 days after biopsy3
Post-biopsy procedure-related complications
Assessment and comparison of procedure-related complications including hematuria, hematospermia, urethral bleeding, and urinary retention.
Time frame
Within 30 days after biopsy4
Pain score after biopsy procedure
Assessment of patient-reported pain using the Visual Analog Scale (VAS) after biopsy.
Time frame
Immediately after biopsy procedureSponsors and contacts
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Source ClinicalTrials.gov