Clinical trial NCT03702439: Prostate Cancer Screening Trial Using Imaging
Official title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Neoplasm
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2018-10-11
Enrollment: 411
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men aged 50-69 years

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
timeFrame: Through study completion, an average of 1 month
measure: The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
timeFrame: Through study completion, an average of 1 month
measure: The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
timeFrame: Through study completion, an average of 1 month
measure: The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: AHMED HASHIM, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wurnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budaus L. Twenty-year trends in prostate cancer stage and grade migration in a large contemporary german radical prostatectomy cohort. Prostate. 2021 Sep;81(12):849-856. doi: 10.1002/pros.24181. Epub 2021 Jun 10.