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NCT07919379Active, not recruiting

ProsBiT: Turkish Prostate Biopsy Study

ProsBiT: Turkish Multicenter Prospective Prostate Biopsy Study

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

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Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
8310 (estimated)
First submitted
1 Nov 2026
Start date
15 Oct 2025
Primary completion date
30 Oct 2026
Lead sponsor
Istanbul Medeniyet University
NCT number
NCT07919379

What you commit to

  • Study type: Observational
  • Planned participants: 8310
  • From 15 Oct 2025 to the primary completion date, 30 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Biopsy performed for active surveillance of known prostate cancer

Other

  • Missing biopsy route or biopsy pathology result

Who the study is looking for

  • Men undergoing transrectal or transperineal prostate biopsy for suspected prostate cancer (elevated PSA and/or abnormal digital rectal examination and/or suspicious MRI) at a participating center
  • Biopsy-naive men and men with a prior negative biopsy

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Istanbul Medeniyet University School of MedicineIstanbulTürkiyeUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.