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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03702439
Other study ID # 18HH4595
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2018
Est. completion date August 22, 2019

Study information

Verified date January 2022
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests: 1. Bi-parametric MRI - reported by a radiologist and CAD-AI system 2. Multiparametric ultrasound - including shearwave elastography 3. A standard-of-care PSA test A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.


Recruitment information / eligibility

Status Completed
Enrollment 411
Est. completion date August 22, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 69 Years
Eligibility Inclusion Criteria: 1. Men aged between 50 and 69 years inclusive at the time of study entry 2. Participants must be fit to undergo all procedures listed in the protocol 3. Estimated life expectancy of 10 years or more 4. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process 5. Participants must be willing and able to provide written informed consent Exclusion Criteria: 1. Previous PSA test or prostate MRI within the prior two years of screening/consent visit 2. Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months 3. Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer 4. Any potential contraindication to MRI 5. Any potential contraindication to prostate biopsy 6. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 7. Any other medical condition precluding procedures described in the protocol

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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