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Prostate Cancer Screening Trial Using Imaging (PROSTAGRAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702439
Recruitment Status : Completed
First Posted : October 11, 2018
Results First Posted : January 27, 2022
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.


Condition or disease
Prostate Neoplasm

Study Design
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Study Type : Observational
Actual Enrollment : 411 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men aged 50-69 years
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702439


Locations
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United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: AHMED HASHIM, Prof Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Study Protocol  [PDF] May 1, 2019
Statistical Analysis Plan  [PDF] October 27, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03702439    
Other Study ID Numbers: 18HH4595
First Posted: October 11, 2018    Key Record Dates
Results First Posted: January 27, 2022
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases