Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
TerminatedNAResults postedLast updated 23 March 2022
What this trial tests
NA trial testing Artemis™ software system in Prostate Cancer in 46 participants. Terminated before completion.
Adults 40 to 85, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Core Cancer LengthPrimary· 2 Months
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)
TP
Group
Value
95% CI
MRI Targeted Biopsy
5
1.875 – 6.75
TR
Group
Value
95% CI
MRI Targeted Biopsy
6
2.1 – 7.75
TP+TR
Group
Value
95% CI
MRI Targeted Biopsy
5
1.95 – 7.25
Percentage of High-Grade Prostate Cancer Using Gleason ScoreSecondary· 2 Months
High-grade prostate cancer is defined as a Gleason score \> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.
Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)
TP
Group
Value
95% CI
MRI Targeted Biopsy
34
TR
Group
Value
95% CI
MRI Targeted Biopsy
40
TP+TR
Group
Value
95% CI
MRI Targeted Biopsy
49
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 23 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03366792.