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Prostate Cancer Screening Trial Using Imaging (PROSTAGRAM)

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ClinicalTrials.gov Identifier: NCT03702439
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

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 Type : Observational
Estimated Enrollment : 364 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
Estimated Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




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 ]

Secondary Outcome Measures :
  1. The proportion of men with screen-positive prostate ultrasound defined by a score of 3 or greater [ Time Frame: Through study completion, an average of 1 month ]
  2. The proportion of participants within each MRI score or US score of 1, 2, 3, 4 or 5 [ Time Frame: Through study completion, an average of 1 month ]
  3. An evaluation of proportion of participants across each MRI and US score with no cancer, insignificant cancer and significant cancer with each test. [ Time Frame: Through study completion, an average of 1 month ]
  4. A comparison of the proportion of participants with a positive result for each screening test. A comparison of the proportion of men subsequently diagnosed with a clinically significant prostate cancer as defined by pre-specified histological definition [ Time Frame: Through study completion, an average of 1 month ]
  5. Comparison of different testing combinations in terms of biopsy rates, detection of insignificant cancer and significant cancers [ Time Frame: Through study completion, an average of 1 month ]


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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

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


Contacts
Contact: David Eldred-Evans 0203 311 5473 d.eldred-evans@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03702439     History of Changes
Other Study ID Numbers: 18HH4595
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases