Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound

Imperial College London1 site in 1 country411 target enrollmentOctober 10, 2018

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Neoplasm
Sponsor: Imperial College London
Enrollment: 411
Locations: 1
Primary Endpoint: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
Status: Completed
Last Updated: 4 years ago

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:

A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.

Registry

clinicaltrials.gov

Start Date

October 10, 2018

End Date

August 22, 2019

Last Updated

4 years ago

Study Type

Observational

Sex

Male

Sponsor

Responsible Party

Sponsor

•Men aged between 50 and 69 years inclusive at the time of study entry
•Participants must be fit to undergo all procedures listed in the protocol
•Estimated life expectancy of 10 years or more
•An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
•Participants must be willing and able to provide written informed consent

•Previous PSA test or prostate MRI within the prior two years of screening/consent visit
•Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months
•Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
•Any potential contraindication to MRI
•Any potential contraindication to prostate biopsy
•Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
•Any other medical condition precluding procedures described in the protocol

The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater

Time Frame: Through study completion, an average of 1 month

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

The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater(Through study completion, an average of 1 month)
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater(Through study completion, an average of 1 month)
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater(Through study completion, an average of 1 month)
The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml(Through study completion, an average of 1 month)