Trial Outcomes & Findings for Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer (NCT NCT03366792)

Last Updated: 2022-03-23

Results Overview

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)

Recruitment status

TERMINATED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

2 Months

Results posted on

2022-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	MRI Targeted Biopsy Artemis™ software system: 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.
Overall Study STARTED	46
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	MRI Targeted Biopsy Artemis™ software system: 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.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	2
Overall Study Ineligible (could not reach perinium)	2
Overall Study Study Closure (interim analysis showed no significant results)	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI Targeted Biopsy n=31 Participants Artemis™ software system: 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.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	MRI Targeted Biopsy n=31 Participants Artemis™ software system: 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.
Core Cancer Length TP	5 mm Interval 1.875 to 6.75
Core Cancer Length TR	6 mm Interval 2.1 to 7.75
Core Cancer Length TP+TR	5 mm Interval 1.95 to 7.25

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	MRI Targeted Biopsy n=31 Participants Artemis™ software system: 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.
Percentage of High-Grade Prostate Cancer Using Gleason Score TP	34 percentage of prostate cancer grades
Percentage of High-Grade Prostate Cancer Using Gleason Score TR	40 percentage of prostate cancer grades
Percentage of High-Grade Prostate Cancer Using Gleason Score TP+TR	49 percentage of prostate cancer grades

Adverse Events

MRI Targeted Biopsy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI Targeted Biopsy n=46 participants at risk Artemis™ software system: 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.
Renal and urinary disorders Hematuria	4.3% 2/46 • 2 months

Additional Information

Samir S. Taneja, MD

NYU Langone Health - Perlmutter Cancer Center

Phone: (212) 263-6301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place