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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04571840




Registration number
NCT04571840
Ethics application status
Date submitted
9/09/2020
Date registered
1/10/2020

Titles & IDs
Public title
Prostate Imaging Using MRI +/- Contrast Enhancement
Scientific title
A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
Secondary ID [1] 0 0
135819
Universal Trial Number (UTN)
Trial acronym
PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Multiparametric MRI +/- prostate biopsy
Diagnosis / Prognosis - Biparametric MRI +/- prostate biopsy

Active comparator: mpMRI - Multiparametric MRI

Experimental: bpMRI - Biparametric MRI


Diagnosis / Prognosis: Multiparametric MRI +/- prostate biopsy
MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings

Diagnosis / Prognosis: Biparametric MRI +/- prostate biopsy
MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of men with clinically significant cancer
Timepoint [1] 0 0
When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcome [1] 0 0
Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
Timepoint [1] 0 0
When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcome [2] 0 0
Agreement between bpMRI and mpMRI for score of suspicion
Timepoint [2] 0 0
When MRI results available, at an expected average of 30 days post-MRI
Secondary outcome [3] 0 0
Agreement between bpMRI and mpMRI for radiological staging decision
Timepoint [3] 0 0
When MRI results available, at an expected average of 30 days post-MRI
Secondary outcome [4] 0 0
Agreement between bpMRI and mpMRI for treatment eligibility
Timepoint [4] 0 0
When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention
Secondary outcome [5] 0 0
Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
Timepoint [5] 0 0
When biopsy results available, at an expected average of 30 days post-MRI
Secondary outcome [6] 0 0
Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
Timepoint [6] 0 0
When biopsy results available, at an expected average of 30 days post-biopsy
Secondary outcome [7] 0 0
Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
Timepoint [7] 0 0
At an expected average of 30 days post-intervention

Eligibility
Key inclusion criteria
1. Men at least 18 years of age referred with clinical suspicion of prostate cancer
2. Serum PSA = 20ng/ml
3. Fit to undergo all procedures listed in protocol
4. Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior prostate biopsy
2. Prior treatment for prostate cancer
3. Prior prostate MRI on a previous encounter
4. Contraindication to MRI
5. Contraindication to prostate biopsy
6. Unfit to undergo any procedures listed in protocol

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne E.
Recruitment hospital [2] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne E.
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Belgium
State/province [4] 0 0
Ghent
Country [5] 0 0
Brazil
State/province [5] 0 0
São Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
Denmark
State/province [7] 0 0
Copenhagen
Country [8] 0 0
Finland
State/province [8] 0 0
Helsinki
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Lille
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Düsseldorf
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Italy
State/province [16] 0 0
Milan
Country [17] 0 0
Italy
State/province [17] 0 0
Rome
Country [18] 0 0
Italy
State/province [18] 0 0
Turin
Country [19] 0 0
Italy
State/province [19] 0 0
Udine
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nijmegen
Country [21] 0 0
Singapore
State/province [21] 0 0
Novena
Country [22] 0 0
Spain
State/province [22] 0 0
Córdoba
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Cambridge
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Veeru Kasivisvanathan, MBBS PhD
Address 0 0
University College, London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Veeru Kasivisvanathan, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
0207 679 5057
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will become available 1 year after publication of the main study results.
Available to whom?
A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04571840