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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Trans-perineal MRI targeted Biopsy; Procedure: Trans-rectal MRI targeted Biopsy

• Registration Number: NCT03650153
• Lead Sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-28
• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 165

Inclusion Criteria

• prostate-specific antigen > 4ng/ml
• Palpation is positive

Exclusion Criteria

• older than 80y
• prostate-specific antigen > 100 ng/ml

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-perineal MRI targeted Biopsy	Trans-perineal MRI targeted Biopsy	Trans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal
Trans-rectal MRI targeted Biopsy	Trans-rectal MRI targeted Biopsy	Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal

Primary Outcome Measures

Name	Time	Method
the rate of positive detections	1 year	the rate of positive detections (How many case are Prostate cancer positive)

Secondary Outcome Measures

Name	Time	Method
the incidence rate of each complication	1 year	the Incidence of complication rate is the number of complications divided by the number of patients and the number of patients with complications. Complications were separated into those with major or minor sequelae and the proportion of each type that were due to medical error (avoidable).

Trial Locations

Locations (1)

King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia