Condition category
Cancer
Date applied
07/12/2011
Date assigned
09/12/2011
Last edited
20/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.ucl.ac.uk/

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

Publication citations

Additional files

Editorial Notes

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.