An interventional study of Trans-rectal MRI targeted Biopsy and Trans-perineal MRI targeted Biopsy in Prostate Cancer, sponsored by Princess Al-Johara Al-Ibrahim Cancer Research Center. Completed at 1 site in Saudi Arabia. Open to male participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Princess Al-Johara Al-Ibrahim Cancer Research Center · Not applicable, Interventional, and Diagnostic
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 165 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Princess Al-Johara Al-Ibrahim Cancer Research Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal
Procedure: Trans-rectal 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-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 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.
the rate of positive detections
the rate of positive detections (How many case are Prostate cancer positive)
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
Plan to share: Undecided
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Princess Al-Johara Al-Ibrahim Cancer Research Center