An observational study in Prostate Cancer (Adenocarcinoma), Prostatic Neoplams and Prostate Specific Antigen, sponsored by Istanbul Medeniyet University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Istanbul Medeniyet University · Observational
ProsBiT is a prospective multicenter observational cohort study that collects standardized data on men undergoing prostate biopsy for suspected prostate cancer at 24 urology centers in Turkey. Clinical, laboratory, imaging, procedural, pathology, complication, and patient-reported pain data are recorded in a common electronic case report form (REDCap). The study aims to compare transperineal and transrectal biopsy in terms of cancer detection, complications, and patient comfort; to evaluate how MRI findings (PI-RADS) and PSA density predict clinically significant prostate cancer, including external validation of published risk-adapted biopsy strategies; to describe variation in biopsy practice between centers; to assess bleeding risk in men using antithrombotic drugs; to examine the agreement between MRI lesion location and biopsy-positive zones; and to describe the learning curve of transperineal biopsy. No intervention is assigned by the study; all diagnostic and treatment decisions are made by the treating physicians according to routine practice.
Background: Prostate biopsy practice is changing rapidly, with increasing use of pre-biopsy MRI, MRI-targeted sampling, and the transperineal (TP) route, which may lower infection risk and reduce the need for antibiotic prophylaxis. Most evidence comes from Western academic centers, and real-world multicenter data from Turkey are lacking.
Design: Prospective, multicenter, observational cohort study. Participating centers enroll men undergoing prostate biopsy and record data in a shared REDCap database using a standardized electronic case report form. Biopsy route, targeting technique, number of cores, local anesthesia, and antibiotic prophylaxis are chosen by each center according to local practice.
Data collected: age, body mass index, Charlson comorbidity index, diabetes mellitus, family history, prior biopsy, urinary tract infection history, medications (alpha-blockers, 5-alpha reductase inhibitors, antithrombotic agents), IPSS, PSA, prostate volume, PSA density, pre-biopsy MRI (multiparametric or biparametric), PI-RADS score and location of the index and secondary lesions on a 24-zone prostate map, biopsy route and technique, local anesthesia technique and agent, antibiotic prophylaxis, number and length of cores, visual analog scale (VAS) pain scores at six procedural steps, willingness to undergo the same procedure again, complications (infection, sepsis, bleeding, hospitalization, intensive care admission, death), and biopsy pathology (ISUP grade group and location of malignant cores).
Planned analyses: (1) transperineal versus transrectal biopsy; (2) PSA density and PI-RADS as predictors of clinically significant prostate cancer and external validation of the Schoots-Padhani risk-adapted biopsy matrix; (3) center-level practice variation; (4) antithrombotic use and bleeding complications by biopsy route; (5) concordance between MRI index-lesion location and malignant-core location; and (6) the learning curve of transperineal biopsy. Multivariable regression with adjustment for clustering by center will be used.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 8,310 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Istanbul Medeniyet University is the lead sponsor of 192 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men under risk of prostate cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men undergoing transrectal ultrasound-guided prostate biopsy (systematic and/or MRI-targeted) as part of routine care.
Men undergoing transperineal prostate biopsy (systematic and/or MRI-targeted) as part of routine care.
Detection rate of clinically significant prostate cancer
Proportion of men with clinically significant prostate cancer (ISUP grade group ≥2) on biopsy pathology, compared between transperineal and transrectal biopsy.
Time frame: At biopsy pathology report (within 4 weeks after biopsy)
Detection rate of any and clinically insignificant prostate cancer
Proportion of men with any adenocarcinoma and with ISUP grade group 1 cancer on biopsy pathology.
Time frame: At biopsy pathology report (within 4 weeks after biopsy)
Procedural pain
Visual analog scale (VAS) pain score, 0 (no pain) to 10 (worst pain), recorded at digital rectal examination, probe insertion, local anesthetic injection, right-lobe sampling, left-lobe sampling, and the end of the procedure.
Time frame: During the biopsy procedure
Patient acceptability
Proportion of men who would choose the same biopsy method again.
Time frame: Immediately after the biopsy procedure
Infectious complications
Proportion of men with post-biopsy infection (including cystitis, urethritis, epididymitis/orchitis) and sepsis.
Time frame: [Within 30 days after biopsy - follow-up window]
Bleeding complications
Proportion of men with hematuria, urethrorrhagia, or perineal hematoma, overall and by antithrombotic use.
Time frame: [Within 30 days after biopsy - follow-up window]
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared publicly because of patient privacy and multicenter data-governance agreements. De-identified aggregate data may be made available upon reasonable request to the steering committee.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Medeniyet University →