Prostate Cancer Screening Trial Using Imaging

Prostate Neoplasm Clinical Trial

— PROSTAGRAM  

Official title:

Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702439
• Other study ID #: 18HH4595
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

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