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Completed

NCT Number: NCT03650153

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

King Khalid University Hospital

Riyadh, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Trans-rectal MRI targeted Biopsy

Procedure

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.

Trans-perineal MRI targeted Biopsy

Procedure

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.

Primary outcomes

  1. the rate of positive detections

    Time frame: 1 year

    the rate of positive detections (How many case are Prostate cancer positive)

Secondary outcomes

  1. the incidence rate of each complication

    Time frame: 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).

Other outcomes

  1. Pain level assessed by visual analogue scale (VAS)

    Time frame: 1 year

    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).

Sponsors and collaborators

Lead sponsor

Princess Al-Johara Al-Ibrahim Cancer Research Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2018
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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