Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Neoplasms
Treatment
Image-Fusion targeted and systematic Biopsy
bpMRI
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Randomisation 1
Inclusion Criteria:
Age 18 years or above (no upper limit)
Patients with a prostate (either cis-male gender or trans-female gender with noprior androgen deprivation hormone use at all).
Referred to hospital and advised to undergo a prostate MRI because of an abnormaldigital 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 forage >/=70 years If family or ethnic risk for prostate cancer, PSA >/=2.5ng/ml forage 45-49 years
Exclusion
Exclusion Criteria:
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 atargeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
Exclusion Criteria:
As above for randomisation 1
Patient refusal for biopsy
Study Design
Study Description
Connect with a study center
Southend University Hospital
Southend-on-Sea, Essex SS0 0RY
United KingdomActive - Recruiting
University Hospital Southampton
Southampton, Hampshire SO16 6YD
United KingdomActive - Recruiting
Medway Maritime Hospital
Gillingham, Kent ME7 5NY
United KingdomSite Not Available
Basingstoke Hospital
Basingstoke, RG24 9NA
United KingdomActive - Recruiting
Southmead Hospital
Bristol, BS10 5NB
United KingdomActive - Recruiting
Cumberland Infirmary
Carlisle, CA2 7HY
United KingdomActive - Recruiting
Darent valley Hospital
Dartford, DA2 8DA
United KingdomActive - Recruiting
Charing Cross Hospial
London, W6 8RF
United KingdomActive - Recruiting
Hillingdon Hospital
Uxbridge, UB8 3NN
United KingdomActive - Recruiting
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