Prostate Cancer Screening Trial Using Imaging

Study Overview
=================
Brief Summary
-----------------
Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests: Bi-parametric MRI - reported by a radiologist and CAD-AI system Multiparametric ultrasound - including shearwave elastography A standard-of-care PSA test A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.

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

Conditions
-----------------
Prostate Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater | Men with a positive MRI defined by a score of 3 or greater | Through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater | 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 | 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 | 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 | Men with screen-positive PSA defined by a >/=3ng/ml | Through study completion, an average of 1 month |