NCT03650153

Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center · Academic / Other
• Sex: Male
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.

Detailed description

This prospective study of comparing transperineal (TP) prostate MRI targeted biopsy with transrectal (TR) prostate MRI targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TP (n = 75) and TR (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analog scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Trans-rectal MRI targeted Biopsy	Trans-rectal biopsy of the prostate: A procedure in which a sample of tissue is removed from the prostate using a thin needle that is inserted through the rectum and into the prostate.
PROCEDURE	Trans-perineal MRI targeted Biopsy	Trans-perineal biopsy of the prostate: The sample is removed with a thin needle that is inserted through the skin of the perineum and into the prostate.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-08-28
• Last updated: 2024-04-03

Locations

1 site across 1 country: Saudi Arabia