Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy (PROCOG)
Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled 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.
Přehled studie
Postavení
Detailní popis
Prostate cancer is one of the most common malignancies among men. Multiparametric magnetic resonance imaging (mpMRI) has become an important tool for prostate cancer detection and risk stratification, particularly with the use of the Prostate Imaging Reporting and Data System (PI-RADS). Patients with PI-RADS 3-5 lesions are frequently considered candidates for targeted prostate biopsy.
Transrectal ultrasound-guided prostate biopsy has traditionally been the standard biopsy approach. However, the transrectal route may carry a risk of infectious complications due to passage through rectal mucosa and exposure to rectal flora. Transperineal prostate biopsy has gained increasing interest because it avoids transgression of the rectal mucosa and may reduce infectious complications.
Cognitive fusion biopsy is an MRI-targeted biopsy technique in which mpMRI findings are mentally correlated with real-time ultrasound images by the operator. This technique provides an accessible alternative to software-based fusion systems and can achieve accurate targeted sampling when performed by experienced clinicians.
The aim of this study is to prospectively compare transperineal and transrectal cognitive fusion prostate biopsy techniques regarding diagnostic performance and safety outcomes in patients with PI-RADS 3-5 lesions detected on mpMRI.
Eligible participants aged 50-75 years with biopsy indications will be randomized using a computer-generated stratified block randomization method. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 years and ≥60 years).
Participants will undergo either transperineal or transrectal cognitive fusion prostate biopsy according to their assigned study group. Systematic biopsy cores and targeted biopsy cores will be obtained according to the institutional protocol.
The primary endpoint is the detection rate of clinically significant prostate cancer, defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer. The primary analysis will evaluate non-inferiority of transperineal biopsy compared with transrectal biopsy.
Secondary endpoints include overall prostate cancer detection rate, Gleason Grade Group ≥2 cancer detection, infectious complications (fever, urinary infection, prostatitis, sepsis), procedure-related complications (hematuria, hematospermia, urinary retention), pain assessed by visual analog scale (VAS), and procedure duration.
Participants will be followed for 30 days after biopsy for assessment of adverse events and complications.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: MUHAMMED Y AYDIN, Doctor
- Telefonní číslo: +90 +90 554 838 4510
- E-mail: mysfa63@gmail.com
Studijní záloha kontaktů
- Jméno: ALPER G GÖK, PROFESSOR DOCTOR
- Telefonní číslo: +90 532 603 1181
- E-mail: alper_gok@hotmail.com
Studijní místa
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turecko (Türkiye), 06170
- Nábor
- Ankara Etlik City Hospital
-
Kontakt:
- ALPER GOK, Proffessor Doctor
- Telefonní číslo: +90 532 603 11 81
- E-mail: alper_gok@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous diagnosis of prostate cancer.
- Active urinary tract infection.
- Coagulopathy or bleeding disorders preventing prostate biopsy.
- Absence of multiparametric prostate MRI evaluation.
- No indication for prostate biopsy.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Transrectal Cognitive Fusion Prostate Biopsy
Participants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.
|
Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
|
|
Experimentální: Transperineal Cognitive Fusion Prostate Biopsy
Participants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.
|
Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Clinically significant prostate cancer detection rate
Časové okno: Within 4 weeks after biopsy (after final pathological evaluation)
|
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.
|
Within 4 weeks after biopsy (after final pathological evaluation)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall prostate cancer detection rate
Časové okno: Within 4 weeks after biopsy (after final pathological evaluation)
|
Comparison of overall prostate cancer detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques
|
Within 4 weeks after biopsy (after final pathological evaluation)
|
|
Post-biopsy infectious complications
Časové okno: Within 30 days after biopsy
|
Assessment and comparison of infectious complications including fever, urinary infection, prostatitis, and sepsis after prostate biopsy.
|
Within 30 days after biopsy
|
|
Post-biopsy procedure-related complications
Časové okno: Within 30 days after biopsy
|
Assessment and comparison of procedure-related complications including hematuria, hematospermia, urethral bleeding, and urinary retention.
|
Within 30 days after biopsy
|
|
Pain score after biopsy procedure
Časové okno: Immediately after biopsy procedure
|
Assessment of patient-reported pain using the Visual Analog Scale (VAS) after biopsy.
|
Immediately after biopsy procedure
|
|
Procedure duration
Časové okno: During biopsy procedure
|
Comparison of procedure duration between transperineal and transrectal cognitive fusion prostate biopsy techniques.
|
During biopsy procedure
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AEŞH-EK-2026-114
- ANKARA ETLIK CITY HOSPİTAL (Jiný identifikátor: ANKARA ETLIK CITY HOSPİTAL)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .