Prostate cancer screening trial using imaging
- Conditions
- Prostate cancerCancerMalignant neoplasms of prostate
- Registration Number
- ISRCTN43502108
- Lead Sponsor
- Imperial College London
- Brief Summary
2021 results in https://doi.org/10.1001/jamaoncol.2020.7456 (added 12/02/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 408
1. Male
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method