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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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Inclusion criteria
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,
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Interventional model
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596 participants in 2 patient groups
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Central trial contact
Pierre-Thierry PIECHAUD, MD; Charlène PY, CRA
Data sourced from clinicaltrials.gov
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