Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer

ConditionsProstate Cancer Adenocarcinoma Prostatic Neoplasms Prostatic Diseases Neoplasms

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

bpMRI
Diagnostic test
biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS.
Image-Fusion targeted and systematic Biopsy
Diagnostic test
During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal.

Treatment groups

3,600 Participants

are divided into 4 treatment groups

Group A: Standard: mpMRINo intervention 0 interventions

Group B: Intervention 1: bpMRIActive comparator 1 intervention

Group C: Standard: Visual estimation targeted and systematic biopsyNo intervention 0 interventions

Group D: Intervention 2: Image-fusion targeted and systematic biopsyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk.

Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.

Time frame