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NCT03366792

Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer

Terminated NA Results posted Last updated 23 March 2022
What this trial tests

NA trial testing Artemis™ software system in Prostate Cancer in 46 participants. Terminated before completion.

Timeline
17 October 2017
Primary endpoint
26 February 2021
26 February 2021

Quick facts

Lead sponsorNYU Langone Health
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment46
Start date17 October 2017
Primary completion26 February 2021
Estimated completion26 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

NYU Langone Health — full company profile →

Who can join

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 Length Primary · 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
GroupValue95% CI
MRI Targeted Biopsy51.875 – 6.75
TR
GroupValue95% CI
MRI Targeted Biopsy62.1 – 7.75
TP+TR
GroupValue95% CI
MRI Targeted Biopsy51.95 – 7.25
Percentage of High-Grade Prostate Cancer Using Gleason Score Secondary · 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
GroupValue95% CI
MRI Targeted Biopsy34
TR
GroupValue95% CI
MRI Targeted Biopsy40
TP+TR
GroupValue95% CI
MRI Targeted Biopsy49

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.

MRI Targeted Biopsy
Serious: 0/46 (0%)
Deaths: 0/46
Other adverse events (1 terms — click to expand)

ReactionSystemMRI Targeted Biopsy
HematuriaRenal and urinary disorders

Data from ClinicalTrials.gov NCT03366792 adverse events section.

Sponsor's own description

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.

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Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other NYU Langone Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing