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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

Tracking Information
First Submitted Date October 2, 2018
First Posted Date October 11, 2018
Results First Submitted Date July 15, 2020
Results First Posted Date January 27, 2022
Last Update Posted Date January 27, 2022
Actual Study Start Date October 10, 2018
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2022)		 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
Original Primary Outcome Measures
 (submitted: October 8, 2018)		 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2022)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: October 8, 2018)
  • 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 ]
  • 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 ]
  • 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: Visit 2 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Cancer Screening Trial Using Imaging
Official Title Prostate Cancer Screening Trial Using A Group of Radiological Approaches Including MRI and Ultrasound
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men aged 50-69 years
Condition Prostate Neoplasm
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Würnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budäus 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2022)		 411
Original Estimated Enrollment
 (submitted: October 8, 2018)		 364
Actual Study Completion Date August 22, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03702439
Other Study ID Numbers 18HH4595
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Imperial College London
Study Sponsor Imperial College London
Collaborators Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: AHMED HASHIM, Prof Imperial College London
PRS Account Imperial College London
Verification Date January 2022