Transperineal, MRI-guided, Prostate Biopsy

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Procedure: Transrectal prostate biopsy (TRB):; Procedure: Transperineal, MRI-guided, prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02651948

6253

Details and patient eligibility

About

Primary purpose:

Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.

Secondary purposes:

• Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.
• Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies
• Study of correlation between radiologic images and anatomopathologic result
• Description of needle track during the procedure
• Description of real time template saturation prostate biopsy
• Comparison of transperineal prostate biopsy relevance according to EBM
• Comparison of 1.5T MRI and 3T MRI for prostate cancer detection

Enrollment: 90 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men
• 40 to 80 years' old
• Affiliation to French social health system
• Signed consent
• Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies
• Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA < 10)

Exclusion criteria

• Gleason > 6 prostate cancer
• Metastatic prostate cancer
• Contraindication to MRI
• Contraindication to general anesthesia
• Non-reversible hemostasis trouble
• Inability to give consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Transperineal prostate biopsy (TPB)

Experimental group

Description:

Transperineal prostate biopsy MRI-guided

Treatment:

Procedure: Transrectal prostate biopsy (TRB):

Transrectal prostate biopsy (TRB)

Active Comparator group

Description:

Transrectal prostate biopsy echo-guided

Treatment:

Procedure: Transperineal, MRI-guided, prostate biopsy