Status:
TERMINATED
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Lead Sponsor:
NYU Langone Health
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk...
Detailed Description
Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostat...
Eligibility Criteria
Inclusion
- No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score \>3/5)
Exclusion
- Prior pelvic radiotherapy
- Evidence of urinary tract infection or significant urinary retention
- Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
- No evidence of suspicious lesions on mpMRI
- Irreversible coagulopathy
- Contraindication to sedation
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03366792
Start Date
October 17 2017
End Date
February 26 2021
Last Update
March 23 2022
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016