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OpenTrials
Completed

NCT Number: NCT03702439

Prostate Cancer Screening Trial Using Imaging

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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Key information

Conditions

Prostate Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–69 year

Sex eligibility

Male

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater

    Time frame: Through study completion, an average of 1 month

    Men with a positive MRI defined by a score of 3 or greater

Secondary outcomes

  1. The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater

    Time frame: Through study completion, an average of 1 month

    Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater

  2. The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater

    Time frame: Through study completion, an average of 1 month

    Men With Screen-positive Prostate US Defined by a Score of 3 or Greater

  3. The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater

    Time frame: Through study completion, an average of 1 month

    Men With Screen-positive Prostate US Defined by a Score of 4 or Greater

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

    Time frame: Through study completion, an average of 1 month

    Men with screen-positive PSA defined by a >/=3ng/ml

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust

Registry information

Official study title

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

Acronym: PROSTAGRAM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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