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NCT Number: NCT05763355

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.

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.

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Key information

Conditions

Patients With Suspected Prostate Cancer Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique St Augustin, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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

Treatment and study plan

Biopsy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison of the rate of rectal bleeding in both groups

    Time frame: 30 days after intervention

  2. Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups

    Time frame: 30 days after intervention

  3. Comparison of the percentage of negative biopsies in both groups

    Time frame: 30 days after intervention

  4. Comparison of the percentage of positive biopsies on on anterior areas in both groups

    Time frame: 30 days after intervention

  5. Comparison of the Percentage of underestimation of the stage of tumor development in both groups

    Time frame: 3 months after intervention

    Confrontation with the MRI result and the resected specimen of the radical prostatectomy

  6. Assess the pain (tolerance) felt by the patient according to the biopsy method used

    Time frame: 1 day

    EVA pain scale at J0

  7. Comparison of the Room occupancy time in both groups

    Time frame: 1 day

  8. Comparison of the Procedure Time in both groups

    Time frame: 1 day

    Procedure time = Endorectal Ultrasound Probe Introduction Time - Probe Removal Time

  9. Comparison of the Average Length of Stay in both groups

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.

Acronym: BIOPROSTABORD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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