Study Stopped
Investigators chose to discontinue the study based on interim findings
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
1 other identifier
interventional
46
1 country
1
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 of infectious complications after biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Oct 2017
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2017
CompletedFirst Submitted
Initial submission to the registry
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedResults Posted
Study results publicly available
March 23, 2022
CompletedMarch 23, 2022
February 1, 2022
3.4 years
November 21, 2017
February 24, 2022
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Core Cancer Length
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
2 Months
Secondary Outcomes (1)
Percentage of High-Grade Prostate Cancer Using Gleason Score
2 Months
Study Arms (1)
MRI Targeted Biopsy
EXPERIMENTALInterventions
Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Samir S. Taneja, MD
- Organization
- NYU Langone Health - Perlmutter Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Samir Taneja, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2017
First Posted
December 8, 2017
Study Start
October 17, 2017
Primary Completion
February 26, 2021
Study Completion
February 26, 2021
Last Updated
March 23, 2022
Results First Posted
March 23, 2022
Record last verified: 2022-02