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

Launched by IMPERIAL COLLEGE LONDON · Oct 7, 2022

Keywords

ClinConnect Summary

The Imperial Prostate 7 trial is studying new methods for detecting prostate cancer. Specifically, it aims to find out if a type of MRI called biparametric MRI (bpMRI) can be a good alternative to a more complex MRI method known as multiparametric MRI (mpMRI) for spotting significant prostate cancers. The trial also compares two ways of performing targeted biopsies, which are procedures used to take samples from the prostate to check for cancer. One method uses special software to combine images from the MRI with ultrasound, while the other relies on the doctor's visual assessment.

To join this trial, participants must be men aged 18 and older who have been advised to get a prostate MRI due to an abnormal exam or high PSA levels, which is a blood test related to prostate health. Participants should also have certain suspicious findings on their MRI that need further investigation. They should not have had a prostate biopsy or MRI in the past two years or a prior diagnosis of prostate cancer. If eligible, participants can expect to undergo the MRI and, if needed, a biopsy to help improve the ways doctors detect and diagnose prostate cancer. This trial is currently recruiting participants, and it represents an important step towards better prostate cancer care.

Gender

MALE

Eligibility criteria

• • 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 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