Patients With Suspected Prostate CancerBIOPROSTABORDNCT05763355
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic
A study testing Biopsy in people with Patients With Suspected Prostate Cancer, run by Elsan at 2 sites in France.
Trial summary
The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Patients With Suspected Prostate Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Dec 2023to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with suspected prostate cancer with at least one of the following criteria met :
- MRI Staging: T2 or T3a,
- MRI Grading: Pirads greater than or equal to 3
- MRI tumor volume greater than or equal to 0.5 cm3
- e.Patient without tumor lesion detected by prostate MRI less than 3 months old with PSA > 4 ng/ml, or an observed suspicious induration to the rectal exam
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
Who cannot join
- Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
- Individuals deprived of liberty or placed under legal guardianship,
- Unwillingness or inability to comply with the study protocol for any reason.
- Patients without a health insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique St Augustin
Bordeaux, France, 33074
Centre Clinical
Soyaux, 16800
About this study
Official title: Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.
The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade.
The first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. There is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. The first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. It would also reduce the risk of rectal bleeding.
Read more
In addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate.
There is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. The aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.
- Conditions
- Patients With Suspected Prostate Cancer
- Being tested
- Biopsy
- Keywords
- Transpérinéal, Transrectal, Biopsy, Prostate, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsies will be performed under local anaesthesia. In all patients with a suspicious lesion (PIRADSv2.1 3-5) noted on the mp-MRI, the software-based image fusion biopsies will be obtained collecting 3 to 5 cores per target area according to its volume, 10-12 systematic cores of the remaining areas of the prostate will be collected from sectors specified in the PIRADSv2.1 prostate map.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal biopsy using KOELIS fusion system | Other | Transrectal procedure will be performed with the patient in the left lateral position with a completely free-hand technique utilising the KOELIS fusion system. Receives: Procedure: Biopsy |
| Transperineal biopsy using KOELIS perine grid | Other | Transperineal biopsy will be performed in the lithotomy position. KOELIS "Perine Grid" needle guidance device and "Steady Pro" free-hand probe arm will be utilised (free-hand assisted technique). Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of occurrence of biopsy-induced infection in both groups
Biopsy-induced infection are defined as :
- Positive post-biopsy urinary test result
- Clinical infection syndrome (T>37.5°C fever)
- Signs of urogenital infection (cystitis/prostatitis/orchi-epididymitis)
- Hospitalization for hyperpyrexia
- Septic shock
Measured: 30 days after intervention
Secondary outcomes (9)
Comparison of the rate of rectal bleeding in both groups
Measured: 30 days after intervention
Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups
Measured: 30 days after intervention
Comparison of the percentage of negative biopsies in both groups
Measured: 30 days after intervention
Comparison of the percentage of positive biopsies on on anterior areas in both groups
Measured: 30 days after intervention
Comparison of the Percentage of underestimation of the stage of tumor development in both groups
Confrontation with the MRI result and the resected specimen of the radical prostatectomy
Measured: 3 months after intervention
Assess the pain (tolerance) felt by the patient according to the biopsy method used
EVA pain scale at J0
Measured: 1 day
Comparison of the Room occupancy time in both groups
Measured: 1 day
Comparison of the Procedure Time in both groups
Procedure time = Endorectal Ultrasound Probe Introduction Time - Probe Removal Time
Measured: 1 day
Comparison of the Average Length of Stay in both groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Dec 2023
- Primary completion7 Jul 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Suspected Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763355
- Sponsor's protocol ID
- 2021-A02436-35
- Acronym
- BIOPROSTABORD
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.
- ClinicalTrials.gov ID
- NCT05763355
- Acronym / sponsor ID
- BIOPROSTABORD / 2021-A02436-35
- Conditions
- Patients With Suspected Prostate Cancer
- Keywords
- Transpérinéal, Transrectal, Biopsy, Prostate, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 10 Mar 2023 (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.
The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade.
The first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. There is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. The first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. It would also reduce the risk of rectal bleeding.
In addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate.
There is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. The aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal biopsy using KOELIS fusion system | Other | Procedure: BiopsyTransrectal procedure will be performed with the patient in the left lateral position with a completely free-hand technique utilising the KOELIS fusion system. |
| Transperineal biopsy using KOELIS perine grid | Other | Procedure: BiopsyTransperineal biopsy will be performed in the lithotomy position. KOELIS "Perine Grid" needle guidance device and "Steady Pro" free-hand probe arm will be utilised (free-hand assisted technique). |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with suspected prostate cancer with at least one of the following criteria met :
- e.Patient without tumor lesion detected by prostate MRI less than 3 months old with PSA > 4 ng/ml, or an observed suspicious induration to the rectal exam
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
Key exclusion criteria (4 listed)
- Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
- Individuals deprived of liberty or placed under legal guardianship,
- Unwillingness or inability to comply with the study protocol for any reason.
- Patients without a health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyBiopsies will be performed under local anaesthesia. In all patients with a suspicious lesion (PIRADSv2.1 3-5) noted on the mp-MRI, the software-based image fusion biopsies will be obtained collecting 3 to 5 cores per target area according to its volume, 10-12 systematic cores of the remaining areas of the prostate will be collected from sectors specified in the PIRADSv2.1 prostate map. | Procedure or surgery | Transperineal biopsy using KOELIS perine grid, Transrectal biopsy using KOELIS fusion system |
Primary outcome
Comparison of the rate of occurrence of biopsy-induced infection in both groups
Time frame: 30 days after intervention
Biopsy-induced infection are defined as : * Positive post-biopsy urinary test result * Clinical infection syndrome (T>37.5°C fever) * Signs of urogenital infection (cystitis/prostatitis/orchi-epididymitis) * Hospitalization for hyperpyrexia * Septic shock
9 secondary outcomes
Comparison of the rate of rectal bleeding in both groups
Time frame: 30 days after intervention
Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups
Time frame: 30 days after intervention
Comparison of the percentage of negative biopsies in both groups
Time frame: 30 days after intervention
Comparison of the percentage of positive biopsies on on anterior areas in both groups
Time frame: 30 days after intervention
Comparison of the Percentage of underestimation of the stage of tumor development in both groups
Time frame: 3 months after intervention
Assess the pain (tolerance) felt by the patient according to the biopsy method used
Time frame: 1 day
Comparison of the Room occupancy time in both groups
Time frame: 1 day
Comparison of the Procedure Time in both groups
Time frame: 1 day
Comparison of the Average Length of Stay in both groups
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Patients With Suspected Prostate Cancer, run by Elsan at 2 sites in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the rate of occurrence of biopsy-induced infection in both groups (time frame: 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.