Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- the rate of positive detections [1 year]
the rate of positive detections (How many case are Prostate cancer positive)
Secondary Outcome Measures
- 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).
Other Outcome Measures
- Pain level assessed by visual analogue scale (VAS) [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
prostate-specific antigen > 4ng/ml
-
Palpation is positive
Exclusion Criteria:
-
older than 80y
-
prostate-specific antigen > 100 ng/ml
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King Khalid University Hospital | Riyadh | Saudi Arabia |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- Danny Rabah Study 2018