Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Recruiting · NCT05574647 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
Image-Fusion targeted and systematic BiopsybpMRI
What this trial is about
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 to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk. To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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 a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)
- Exclusion Criteria:
- As above for randomisation 1
- Patient refusal for biopsy
Where it is running
15 locations listed.
- Basingstoke Hospital - Basingstoke, United Kingdom
- Southmead Hospital - Bristol, United Kingdom
- Addenbrooke Hospital, Cambridge - Cambridge, United Kingdom
- Cumberland Infirmary - Carlisle, United Kingdom
- St Peters Hospital - Chertsey, United Kingdom
- Darent valley Hospital - Dartford, United Kingdom
- Northwick Park Hospital - Harrow, United Kingdom
- St James's Hospital, Leeds - Leeds, United Kingdom
- Charing Cross Hospial - London, United Kingdom
- Manchester Royal Infirmary - Manchester, United Kingdom
- Northampton General Hospital - Northampton, United Kingdom
- Hillingdon Hospital - Uxbridge, United Kingdom
- Southend University Hospital - Southend-on-Sea, Essex, United Kingdom
- University Hospital Southampton - Southampton, Hampshire, United Kingdom
- Medway Maritime Hospital - Gillingham, Kent, United Kingdom