NCT03702439

Brief Summary

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests:

  1. 1.Bi-parametric MRI - reported by a radiologist and CAD-AI system
  2. 2.Multiparametric ultrasound - including shearwave elastography
  3. 3.A standard-of-care PSA test

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

October 2, 2018

Results QC Date

July 15, 2020

Last Update Submit

January 25, 2022

Conditions

Prostate Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml

    Through study completion, an average of 1 month

Eligibility Criteria

Age50 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men aged 50-69 years

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (2)

  • Eldred-Evans D, Winkler M, Klimowska-Nassar N, Burak P, Connor MJ, Fiorentino F, Day E, Price D, Gammon M, Tam H, Sokhi H, Padhani AR, Ahmed HU. Perceived patient burden and acceptability of MRI in comparison to PSA and ultrasound: results from the IP1-PROSTAGRAM study. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):531-537. doi: 10.1038/s41391-023-00662-6. Epub 2023 Mar 31.

    PMID: 37002379DERIVED

  • 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.

    PMID: 34110033DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
David Eldred-Evans
Organization
Imperial Prostate
d.eldred-evans@imperial.ac.uk
020 7594 7773

Study Officials

  • AHMED HASHIM, Prof

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 11, 2018

Study Start

October 10, 2018

Primary Completion

May 15, 2019

Study Completion

August 22, 2019

Last Updated

January 27, 2022

Results First Posted

January 27, 2022

Record last verified: 2022-01

Locations

GB(1)