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Clinical Trials/ISRCTN43502108
ISRCTN43502108
Completed
未知

PROstate cancer Screening Trial using A Group of Radiological Approaches including MRI and ultrasound

Imperial College London0 sites408 target enrollmentOctober 8, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Imperial College London
Enrollment
408
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

2021 results in https://doi.org/10.1001/jamaoncol.2020.7456 (added 12/02/2021)

Registry
who.int
Start Date
October 8, 2018
End Date
September 2, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • 2\. Aged 50\-69 years
  • 3\. Fit to undergo all procedures listed in the protocol
  • 4\. Estimated life expectancy of 10 years or more
  • 5\. Understanding of the English language sufficient to understand written and verbal information about the trial and consent process
  • 6\. 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 (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
  • 4\. Any potential contraindication to MRI, including but not limited to:
  • 4\.1\. Devices or metallic foreign bodies such as pacemakers, implantable defibrillators, neurostimulators, cochlear implants, coronary stents, prosthetic heart valves, aneurysm clips and other intravascular devices
  • 4\.2\. Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal
  • 4\.3\. Claustrophobia
  • 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

Outcomes

Primary Outcomes

Not specified

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