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Diagnostic Test

MRI Scans for Prostate Cancer (PRIME Trial)

N/A
Waitlist Available
Led By Shonit Punwani, PhD FRCR
Research Sponsored by University College, London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Prior treatment for prostate cancer
Contraindication to prostate biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at an expected average of 30 days post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two types of MRI scans to see if one is better than the other at detecting prostate cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the MRI procedure itself or reactions related to the use of IV contrast in mpMRI such as allergic reactions, nausea, headache, pain at injection site, or very rarely kidney problems.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment for prostate cancer before.
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I cannot undergo a prostate biopsy due to health risks.
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I am not fit for the procedures mentioned in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at an expected average of 30 days post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at an expected average of 30 days post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Agreement between bpMRI and mpMRI for score of suspicion
Agreement between bpMRI and mpMRI for treatment eligibility
Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: bpMRIExperimental Treatment1 Intervention
Biparametric MRI
Group II: mpMRIActive Control1 Intervention
Multiparametric MRI

Find a Location

Who is running the clinical trial?

University College, LondonLead Sponsor
862 Previous Clinical Trials
38,752,960 Total Patients Enrolled
24 Trials studying Prostate Cancer
26,618 Patients Enrolled for Prostate Cancer
Shonit Punwani, PhD FRCRPrincipal InvestigatorUniversity College, London
Francesco Giganti, MDPrincipal InvestigatorUniversity College, London

Media Library

Biparametric MRI (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04571840 — N/A
Prostate Cancer Research Study Groups: mpMRI, bpMRI
Prostate Cancer Clinical Trial 2023: Biparametric MRI Highlights & Side Effects. Trial Name: NCT04571840 — N/A
Biparametric MRI (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571840 — N/A
~0 spots leftby Dec 2024
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