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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Trans-rectal MRI targeted Biopsy; Procedure: Trans-perineal MRI targeted Biopsy

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 Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karim H Farhat, PhD; Phone Number: +966114679748; Email: kfarhat@ksu.edu.sa
• Study Contact Backup: Name: Danny M Rabah, PhD; Phone Number: +966114679748; Email: drabah@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Khalid University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trans-rectal MRI targeted Biopsy; Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal	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.
Active Comparator: Trans-perineal MRI targeted Biopsy; Trans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of positive detections	the rate of positive detections (How many case are Prostate cancer positive)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence rate of each complication	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).	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level assessed by visual analogue scale (VAS)	The pain VAS is a unidimensional measure of pain intensity used adult populations. The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on intended use of the scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).	1 year

Collaborators and Investigators

• Sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
• Investigators: Principal Investigator: danny M Rabah, FRCS, Surgery Department and Cancer Research Chair, College of Medicine, King Saud University, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Danny Rabah Study 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No