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

Princess Al-Johara Al-Ibrahim Cancer Research Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Trans-rectal MRI targeted Biopsy; Procedure: Trans-perineal MRI targeted Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03650153

Danny Rabah Study 2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: Male

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups

Trans-rectal MRI targeted Biopsy

Active Comparator group

Description:

Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal

Treatment:

Procedure: Trans-rectal MRI targeted Biopsy

Trans-perineal MRI targeted Biopsy

Active Comparator group

Description:

Trans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal

Treatment:

Procedure: Trans-perineal MRI targeted Biopsy