Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research Center
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- the rate of positive detections
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •prostate-specific antigen \> 4ng/ml
- •Palpation is positive
Exclusion Criteria
- •older than 80y
- •prostate-specific antigen \> 100 ng/ml
Outcomes
Primary Outcomes
the rate of positive detections
Time Frame: 1 year
the rate of positive detections (How many case are Prostate cancer positive)
Secondary Outcomes
- the incidence rate of each complication(1 year)