Trial Outcomes & Findings for Prostate Cancer Screening Trial Using Imaging (NCT NCT03702439)

NCT ID: NCT03702439

Last Updated: 2022-01-27

Results Overview

Men with a positive MRI defined by a score of 3 or greater

• Recruitment status: COMPLETED
• Target enrollment: 411 participants
• Primary outcome timeframe: Through study completion, an average of 1 month
• Results posted on: 2022-01-27

Participant Flow

Participant enrollment (411) exceeded the planned protocol enrollment (406) due to the logistics of mpMRI at the screening site. The TMG agreed that over-recruitment could occur on a single day to maximize MRI availability

Participant milestones

Measure	MRI, PSA and US Group Men eligible for screening with a short MRI or PSA or ultrasound
Overall Study STARTED	408
Overall Study COMPLETED	408
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prostate Cancer Screening Trial Using Imaging

Baseline characteristics by cohort

Measure	MRI, PSA and US Group n=408 Participants Men screened by PSA, MRI and US
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	352 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	408 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	94 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	132 Participants n=5 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 1 month

Population: All patients who had an MRI screening test

Men with a positive MRI defined by a score of 3 or greater

Outcome measures

Measure	Short MRI Arm n=406 Participants Men who had a Short MRI in study
The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater	17.7 Percentage of participants Interval 14.3 to 21.8

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Population: All men who had a short MRI

Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater

Outcome measures

Measure	Short MRI Arm n=406 Participants Men who had a Short MRI in study
The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater	10.6 Percentage of participants Interval 7.9 to 14.0

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Population: All men who had a ultrasound

Men With Screen-positive Prostate US Defined by a Score of 3 or Greater

Outcome measures

Measure	Short MRI Arm n=405 Participants Men who had a Short MRI in study
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater	23.7 Percentage of participants Interval 19.8 to 28.1

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Population: All men who had a ultrasound

Men With Screen-positive Prostate US Defined by a Score of 4 or Greater

Outcome measures

Measure	Short MRI Arm n=405 Participants Men who had a Short MRI in study
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater	12.8 Percentage of participants Interval 9.0 to 16.5

SECONDARY outcome

Timeframe: Through study completion, an average of 1 month

Population: Men with screen-positive PSA defined by a \>/=3ng/ml

Men with screen-positive PSA defined by a >/=3ng/ml

Outcome measures

Measure	Short MRI Arm n=406 Participants Men who had a Short MRI in study
The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml	9.9 Percentage of participants Interval 7.3 to 13.2

Adverse Events

MRI, PSA and US Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Eldred-Evans

Imperial Prostate

Phone: 020 7594 7773

Email: d.eldred-evans@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place