MRI Scans for Prostate Cancer

(PRIME Trial)

Recruiting at 44 trial locations

Overseen By Pramit Khetrapal, MBBS PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University College, London

Disqualifiers: Prior biopsy, Prior treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer. This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

Research Team

Caroline Moore, MD FRCS

Principal Investigator

University College, London

Mark Emberton, MD FRCS

Principal Investigator

University College, London

Clare Allen, FRCR

Principal Investigator

University College London Hospital

Shonit Punwani, PhD FRCR

Principal Investigator

University College, London

Francesco Giganti, MD

Principal Investigator

University College, London

Veeru Kasivisvanathan, MBBS PhD

Principal Investigator

University College, London

Eligibility Criteria

This trial is for men over 18 suspected of having prostate cancer, with a PSA level ≤ 20ng/ml, and fit to undergo MRI scans and biopsies. It's not for those who've had previous prostate biopsies or MRIs, have contraindications to MRI or biopsy procedures, or have been treated for prostate cancer before.

Inclusion Criteria

I am a man, 18 or older, suspected to have prostate cancer.

I am physically fit to undergo all required medical procedures.

Able to provide written informed consent

Exclusion Criteria

I cannot undergo a prostate biopsy due to health risks.

You have had a biopsy of your prostate before.

You cannot undergo an MRI scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Assessment

Participants undergo bpMRI and mpMRI to assess the presence of clinically significant prostate cancer

1 week

1 visit (in-person)

Biopsy and Evaluation

Participants with suspicious MRI findings undergo targeted and systematic biopsy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI and biopsy

4 weeks

Treatment Details

Interventions

• Biparametric MRI
• Multiparametric MRI

Trial Overview The PRIME study is comparing two types of MRI scans in detecting significant prostate cancer: multiparametric (mpMRI) which uses IV contrast and biparametric (bpMRI) which does not. The goal is to see if bpMRI can match mpMRI's effectiveness without needing contrast.

Participant Groups

Group I: bpMRI Experimental Treatment 1 Intervention

Biparametric MRI

Group II: mpMRI Active Control 1 Intervention

Multiparametric MRI

Who Is Running the Clinical Trial?

University College, London

Lead Sponsor

Trials

884

Recruited

38,770,000+