Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorImperial College London
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- bpMRI
- Image-Fusion targeted and systematic Biopsy
Treatment groups
3,600 Participants
are divided into 4 treatment groupsSponsors and collaborators
Imperial College London
Lead sponsor
Cancer Research UK
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov