Contact information
Type
Scientific
Primary contact
Prof Mark Emberton
ORCID ID
Contact details
MRC Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
-
MRCCTU.PROMIS@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01292291
Protocol/serial number
PROMIS PR11; HTA 09/22/67
Study information
Scientific title
PROstate MRI Imaging Study (PROMIS): evaluation of multi-parametric magnetic imaging in the diagnosis and characterisation of prostate cancer
Acronym
PROMIS
Study hypothesis
1. In men identified with clinical suspicion of prostate cancer, those with favourable MP-MRI results could safely avoid unnecessary biopsy
2. An MP-MRI based pathway can improve the rate of detection of clinically significant cancer as compared to TRUS biopsy
3. An MP-MRI based diagnostic pathway can be cost-effective
More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/092267/#/
Ethics approval
North West London Research Ethics Committee, 16/03/2011, ref: 11/LO/0185
Study design
Prospective validating paired cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Prostate cancer
Intervention
All patients will receive the same treatment - Multi-parametric MRI scan and the combined prostate biopsy procedure (Template Prostate Mapping biopsy [TPM], followed by Trans Rectal Ultrasound Biopsy [TRUS]).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
2. Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values [an overall MP-MRI score will be given from 1-5 (definite benign 1, probably benign 2, indeterminate 3, probably malignant 4, definitely malignant 5), where the primary definition of a positive result is MP-MRI score of ≥3]
3. Primary definition of cancer according to biopsy: Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 6 mm
Secondary outcome measures
1. Evaluation of MRI according to secondary definition of prostate cancer (Dominant Gleason pattern ≥ 4 and/or cancer core length ≥ 4 mm)
2. Evaluation of the optimal combination of MP-MRI parameters (T2, DW, DCE)
3. Cost-effectiveness
4. Inter-observer variation in the reporting of MP-MRI
5. Evaluation of factors associated with detection of clinically significant prostate cancer
6. Outcomes associated with translational work
Overall trial start date
28/03/2012
Overall trial end date
28/04/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Are aged 18 years or over, are at risk of prostate cancer and have been advised to have a prostate biopsy
2. Have a serum prostate-specific antigen (PSA) value of less than or equal 15ng/ml in the last 3 months
3. Have suspected less than or equal T2 on rectal examination
4. Are fit for general/spinal anaesthesia and all study procedures
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
714
Participant exclusion criteria
Current exclusion criteria as of 22/05/2012:
1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months
2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer
3. Have urinary tract infection or history of acute prostatitis within the last 3 months
4. Have a contraindication to MRI or any other medical condition precluding study procedures
5. Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work.
Previous exclusion criteria:
1. Have been treated using 5-alpha reductase inhibitors at time of registration or during the prior 6 months
2. Have a previous history of prostate biopsy, prostate surgery or treatment for prostate cancer
3. Have urinary tract infection or history of acute prostatitis within the last 3 months
4. Have a contraindication to MRI or any other medical condition precluding study procedures
5. Have previous history of hip replacement surgery
Recruitment start date
28/03/2012
Recruitment end date
28/04/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit at UCL
London
WC2B 6NH
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
c/o Professor Mark Emberton
Division of Surgery and Interventional Sciences
67 Riding House Street
London
W1P 7NN
United Kingdom
-
m.emberton@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25749312
2017 results in: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32401-1/fulltext