Prostate Cancer Screening Trial Using Imaging

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes