Prostate Cancer (Adenocarcinoma)ProsBiTNCT07919379
ProsBiT: Turkish Prostate Biopsy Study
An observational study of Prostate Cancer (Adenocarcinoma) and Prostatic Neoplams, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostatic Neoplams, Prostate Specific Antigen
- How many people
- 8,310 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 31 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men under risk of prostate cancer
Who may be able to join
- 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
Who cannot join
- Biopsy performed for active surveillance of known prostate cancer
- Missing biopsy route or biopsy pathology result
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University School of Medicine
Istanbul
About this study
Official title: ProsBiT: Turkish Multicenter Prospective Prostate Biopsy Study
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.
Read the detailed description
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.
- Keywords
- prostate biopsy, transperineal biopsy, transrectal biopsy, PSA density, PI-RADS, multiparametric MRI, prostate cancer, antibiotic prophylaxis, learning curve
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal biopsy | Men undergoing transrectal ultrasound-guided prostate biopsy (systematic and/or MRI-targeted) as part of routine care. | |
| Transperineal biopsy | Men undergoing transperineal prostate biopsy (systematic and/or MRI-targeted) as part of routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At biopsy pathology report (within 4 weeks after biopsy)
Secondary outcomes (5)
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.
Measured: 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.
Measured: During the biopsy procedure
Patient acceptability
Proportion of men who would choose the same biopsy method again.
Measured: Immediately after the biopsy procedure
Infectious complications
Proportion of men with post-biopsy infection (including cystitis, urethritis, epididymitis/orchitis) and sepsis.
Measured: [Within 30 days after biopsy - follow-up window]
Bleeding complications
Proportion of men with hematuria, urethrorrhagia, or perineal hematoma, overall and by antithrombotic use.
Measured: [Within 30 days after biopsy - follow-up window]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start15 Oct 2025
- Primary completion30 Oct 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,310 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Harran University, Kutahya Health Sciences University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Bagcilar Training and Research Hospital, Giresun University, Ankara City Hospital Bilkent, Başakşehir Çam & Sakura City Hospital, Mersin University, School of Medicine, Malatya Turgut Ozal University, Haseki Training and Research Hospital, Ankara Etlik City Hospital, Adana City Training and Research Hospital, Samsun Education and Research Hospital, Trabzon Kanuni Education and Research Hospital, Konya City Hospital, Izmir City Hospital, University of Gaziantep, Tepecik Training and Research Hospital
- Responsible party
- Principal investigator, Hüseyin Özgür Kazan, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919379
- Sponsor's protocol ID
- 2025/0327
- Acronym
- ProsBiT
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Schoots IG, Padhani AR. Risk-adapted biopsy decision based on prostate magnetic resonance imaging and prostate-specific antigen density for enhanced biopsy avoidance in first prostate cancer diagnostic evaluation. BJU Int. 2021 Feb;127(2):175-178. doi: 10.1111/bju.15277. Epub 2020 Nov 13. No abstract available.
PubMed 33089586
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProsBiT: Turkish Multicenter Prospective Prostate Biopsy Study
- ClinicalTrials.gov ID
- NCT07919379
- Acronym / sponsor ID
- ProsBiT / 2025/0327
- Keywords
- prostate biopsy, transperineal biopsy, transrectal biopsy, PSA density, PI-RADS, multiparametric MRI, prostate cancer, antibiotic prophylaxis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,310 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Harran University, Kutahya Health Sciences University, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Bagcilar Training and Research Hospital, Giresun University, Ankara City Hospital Bilkent, Başakşehir Çam & Sakura City Hospital, Mersin University, School of Medicine, Malatya Turgut Ozal University, Haseki Training and Research Hospital, Ankara Etlik City Hospital, Adana City Training and Research Hospital, Samsun Education and Research Hospital, Trabzon Kanuni Education and Research Hospital, Konya City Hospital, Izmir City Hospital, University of Gaziantep, Tepecik Training and Research Hospital
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal biopsy | – | –Men undergoing transrectal ultrasound-guided prostate biopsy (systematic and/or MRI-targeted) as part of routine care. |
| Transperineal biopsy | – | –Men undergoing transperineal prostate biopsy (systematic and/or MRI-targeted) as part of routine care. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men under risk of prostate cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Biopsy performed for active surveillance of known prostate cancer
- Missing biopsy route or biopsy pathology result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rate of clinically significant prostate cancer
Time frame: At biopsy pathology report (within 4 weeks after biopsy)
Proportion of men with clinically significant prostate cancer (ISUP grade group ≥2) on biopsy pathology, compared between transperineal and transrectal biopsy.
5 secondary outcomes
Detection rate of any and clinically insignificant prostate cancer
Time frame: At biopsy pathology report (within 4 weeks after biopsy)
Procedural pain
Time frame: During the biopsy procedure
Patient acceptability
Time frame: Immediately after the biopsy procedure
Infectious complications
Time frame: [Within 30 days after biopsy - follow-up window]
Bleeding complications
Time frame: [Within 30 days after biopsy - follow-up window]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 33089586Schoots IG, Padhani AR. Risk-adapted biopsy decision based on prostate magnetic resonance imaging and prostate-specific antigen density for enhanced biopsy avoidance in first prostate cancer diagnostic evaluation. BJU Int. 2021 Feb;127(2):175-178. doi: 10.1111/bju.15277. Epub 2020 Nov 13. No abstract available.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma) and Prostatic Neoplams, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of clinically significant prostate cancer (time frame: At biopsy pathology report (within 4 weeks after biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.