Prostate MRI imaging study

ISRCTN	ISRCTN16082556
DOI	https://doi.org/10.1186/ISRCTN16082556
ClinicalTrials.gov (NCT)	NCT01292291
Protocol serial number	PROMIS PR11; HTA 09/22/67
Sponsor	University College London (UK)
Funder	Health Technology Assessment Programme

Submission date: 07/12/2011
Registration date: 09/12/2011
Last edited: 24/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-more-detailed-type-mri-scan-help-improve-diagnosis-prostate-cancer-promis

Contact information

Prof Mark Emberton
Scientific

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Email	MRCCTU.PROMIS@ucl.ac.uk

Study information

Primary study design	Observational
Study design	Prospective validating paired cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	PROstate MRI Imaging Study (PROMIS): evaluation of multi-parametric magnetic imaging in the diagnosis and characterisation of prostate cancer
Study acronym	PROMIS
Study objectives	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(s)	North West London Research Ethics Committee, 16/03/2011, ref: 11/LO/0185
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	28/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	714
Key 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
Key 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
Date of first enrolment	28/03/2012
Date of final enrolment	28/04/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinical Trials Unit at UCL

London
WC2B 6NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/02/2017		Yes	No
Results article	results	01/07/2018		Yes	No
Protocol article	protocol	01/05/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			24/03/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/03/2022: Plain English results added.
25/07/2018: Publication references added.

20/01/2017: Publication references added.

22/05/2012: The following changes were made to the trial record:
1. The overall start date was changed from 30/01/2012 to 28/03/2012.
2. The overall trial end date was changed from 30/01/2016 to 28/04/2015.