Prostate Cancer Screening Trial Using Imaging

Completed

• Conditions: Prostate Neoplasm

• Registration Number: NCT03702439
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-08
• Study Start: 2018-10-10
• Study First Posted: 2018-10-11
• Primary Completion: 2019-05-15
• Study Completion: 2019-08-22
• Results First Submitted: 2020-07-15
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Results First Posted: 2022-01-27
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 411

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater	Through study completion, an average of 1 month	Men with a positive MRI defined by a score of 3 or greater

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom