Biparametric MRI +/- prostate biopsy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Radboudumc, Nijmegen, NetherlandsProstate CancerBiparametric MRI +/- prostate biopsy - DiagnosticTest
Eligibility
18+
Male
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Study Summary

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

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: At an expected average of 30 days post-intervention

Day 30
Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
Day 30
Agreement between bpMRI and mpMRI for radiological staging decision
Agreement between bpMRI and mpMRI for score of suspicion
Day 30
Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
Day 30
Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
Proportion of men with clinically significant cancer
Day 30
Agreement between bpMRI and mpMRI for treatment eligibility

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

mpMRI
1 of 2
bpMRI
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: Biparametric MRI +/- prostate biopsy · No Placebo Group · N/A

bpMRI
DiagnosticTest
Experimental Group · 1 Intervention: Biparametric MRI +/- prostate biopsy · Intervention Types: DiagnosticTest
mpMRI
DiagnosticTest
ActiveComparator Group · 1 Intervention: Multiparametric MRI +/- prostate biopsy · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at an expected average of 30 days post-intervention

Who is running the clinical trial?

University College, LondonLead Sponsor
772 Previous Clinical Trials
38,851,449 Total Patients Enrolled
19 Trials studying Prostate Cancer
18,469 Patients Enrolled for Prostate Cancer
Francesco Giganti, MDPrincipal InvestigatorUniversity College, London
Veeru Kasivisvanathan, MBBS PhDStudy ChairUniversity College, London
Caroline Moore, MD FRCSPrincipal InvestigatorUniversity College, London
1 Previous Clinical Trials
500 Total Patients Enrolled
Mark Emberton, MD FRCSPrincipal InvestigatorUniversity College, London
1 Previous Clinical Trials
500 Total Patients Enrolled
Clare Allen, FRCRPrincipal InvestigatorUniversity College London Hospital
Shonit Punwani, PhD FRCRPrincipal InvestigatorUniversity College, London

Eligibility Criteria

Age 18+ · Male Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

What is the current enrollment cap of this clinical trial?

"To complete this study, 500 qualified participants must be enrolled. Potential enrollees can visit one of the many trial sites such as Jewish General Hospital in Montréal and University of Chicago located in Minnesota." - Anonymous Online Contributor

Unverified Answer

Are there any Canadian facilities currently undertaking this research initiative?

"8 medical centres across North America are hosting this clinical trial. Participants will be able to find one close by, as the sites span Montréal, Chicago and New York along with 8 other cities. This should reduce travel needs for those who choose to join the study." - Anonymous Online Contributor

Unverified Answer

Is enrollment for the clinical trial still available?

"Clinicaltrials.gov states that this research is still recruiting participants, with the initial posting occuring on April 5th 2022 and last update occurring on May 11th of the same year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.