Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal
1 other identifier
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 3, 2024
April 1, 2024
3 years
August 27, 2018
April 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the rate of positive detections
the rate of positive detections (How many case are Prostate cancer positive)
1 year
Secondary Outcomes (1)
the incidence rate of each complication
1 year
Other Outcomes (1)
Pain level assessed by visual analogue scale (VAS)
1 year
Study Arms (2)
Trans-rectal MRI targeted Biopsy
ACTIVE COMPARATORTrans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal
Trans-perineal MRI targeted Biopsy
ACTIVE COMPARATORTrans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal
Interventions
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.
Eligibility Criteria
You may qualify if:
- prostate-specific antigen \> 4ng/ml
- Palpation is positive
You may not qualify if:
- older than 80y
- prostate-specific antigen \> 100 ng/ml
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Khalid University Hospital
Riyadh, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
danny M Rabah, FRCS
Surgery Department and Cancer Research Chair, College of Medicine, King Saud University, Saudi Arabia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 28, 2018
Study Start
January 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 3, 2024
Record last verified: 2024-04