Status:
RECRUITING
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Cancer Research UK
National Institute for Health Research, United Kingdom
Conditions:
Prostate Cancer
Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer. To determine whether biparametric MRI (bpMRI) could be recommended as an alternative ...
Detailed Description
Background and study aims: The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue s...
Eligibility Criteria
Inclusion
- Randomisation 1
- Age 18 years or above (no upper limit)
- Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
- Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and/or an elevated PSA (within 6 months of screening visit) PSA \>/=3.0ng/ml for age 50-69 years PSA \>/=5.0ng/ml for age \>/=70 years If family or ethnic risk for prostate cancer, PSA \>/=2.5ng/ml for age 45-49 years
Exclusion
- PSA \>50ng/ml
- Prior prostate MRI or prostate biopsy in the two years prior to screening visit
- Prior diagnosis of prostate cancer
- Contraindication to MRI or gadolinium contrast
- Previous hip replacement to both hips
- Contraindication to performing a biopsy guided by a transrectal ultrasound probe
- Randomisation 2
- Inclusion Criteria:
- Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
Key Trial Info
Start Date :
November 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
3600 Patients enrolled
Trial Details
Trial ID
NCT05574647
Start Date
November 2 2022
End Date
January 31 2026
Last Update
July 24 2025
Active Locations (15)
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1
Southend University Hospital
Southend-on-Sea, Essex, United Kingdom, SS0 0RY
2
University Hospital Southampton
Southampton, Hampshire, United Kingdom, SO16 6YD
3
Medway Maritime Hospital
Gillingham, Kent, United Kingdom, ME7 5NY
4
Basingstoke Hospital
Basingstoke, United Kingdom, RG24 9NA