Status:
UNKNOWN
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Bumjin Lim
Dalsan Yoo
Conditions:
Prostate Cancer
Eligibility:
MALE
50-80 years
Phase:
NA
Brief Summary
This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspic...
Detailed Description
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a...
Eligibility Criteria
Inclusion
- 1\. Men undergoing a first-time prostate biopsy to rule out cancer
- 2\. Serum PSA ≥3ng/mL, ≤20ng/mL
- 3\. Age≥50 years, ≤80 years
- 4\. Clinical stage ≤T2c
- 5\. Patients must be able to provide written informed consent.
Exclusion
- 1\. Patients has any prior needle biopsy of the prostate
- 2\. Patients has a prior history of prostate cancer
- 3\. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- 4\. Patients has a prior history of BPH operation
- 5\. Patient with uncorrectable coagulopathies
- 6\. Unable to tolerate a TRUS guided biopsy.
- 7\. Patients had 5-alpha reductase inhibitor in the past six months.
- 8\. The patient has had a urinary tract infection or acute prostatitis in the last three months.
- 9\. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
Key Trial Info
Start Date :
March 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04320147
Start Date
March 23 2020
End Date
April 1 2023
Last Update
March 25 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736