Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
About this study
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.
- Condition
- Prostate Cancer, Adenocarcinoma, Prostatic Neoplasms, Prostatic Diseases, Neoplasms
- Tested
- bpMRI, Image-Fusion targeted and systematic Biopsy
- Sponsor
- Imperial College London
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer, Adenocarcinoma, Prostatic Neoplasms, Prostatic Diseases, Neoplasms
- 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
- 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 9
- 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
- As above for randomisation 1
- Patient refusal for biopsy
Where
15 sites, 15 recruiting
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
and 9 more sites on ClinicalTrials.gov
Contact
-
Hashim Ahmed
0203 311 1673 hashim.ahmed@imperial.ac.uk
-
Thiagarajah Sasikaran
0207 594 6017 t.sasikaran@imperial.ac.uk
Potential match only. Final eligibility is determined by the study team.