N/A
N=408
Prostate Cancer Screening Trial Using Imaging
Prostate Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03702439 ↗Enrolled (actual)
408
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater — 17.7 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Imperial College London
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater |
17.7 | — |
| SECONDARY The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater |
10.6 | — |
| SECONDARY The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater |
23.7 | — |
| SECONDARY The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater |
12.8 | — |
| SECONDARY The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml |
9.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03702439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.