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

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

Recruiting
Male
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Patients with suspected prostate cancer with at least one of the following criteria met :
    1. MRI Staging: T2 or T3a,
    2. MRI Grading: Pirads greater than or equal to 3
    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

Study details
    Patients With Suspected Prostate Cancer

NCT05763355

Elsan

7 March 2024

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