Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer

Transperineal, MRI-guided, Prostate Biopsy

Sponsors

Lead sponsor: University Hospital, Strasbourg, France

Source University Hospital, Strasbourg, France
Brief Summary

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

Overall Status Recruiting
Start Date May 2015
Completion Date August 2022
Primary Completion Date August 2022
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Collection of complications and rehospitalizations by using questionnaire 12 months
Enrollment 90
Condition
Intervention

Intervention type: Procedure

Intervention name: Transperineal, MRI-guided, prostate biopsy

Arm group label: Transrectal prostate biopsy (TRB)

Intervention type: Procedure

Intervention name: Transrectal prostate biopsy (TRB):

Arm group label: Transperineal prostate biopsy (TPB)

Eligibility

Criteria:

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

Gender: Male

Minimum age: 40 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Contact

Last name: Lang Hervé, MD

Email: [email protected]

Location
facility status contact
Service d'urologie Recruiting Hervé Lang, MD [email protected]
Location Countries

France

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Transperineal prostate biopsy (TPB)

Arm group type: Experimental

Description: Transperineal prostate biopsy MRI-guided

Arm group label: Transrectal prostate biopsy (TRB)

Arm group type: Active Comparator

Description: Transrectal prostate biopsy echo-guided

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov